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Meet us at 2015 Drug Delivery Partnerships Conference!

January 28-30 | Boca Raton, FL USA

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Jan
21
2014

InformEx

The event brings together an international mix of motivated buyers, manufacturers, distributors and sellers of high value chemistry for 4 days of sourcing, education & networking.

Visit us at booth # 1010

Dr. Kevin Kane will be presenting on the topic of late stageAPI development.

http://www.informex.com/informex-usa

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Jan
27
2014

3rd Drug Formulation & Bioavailability Conference

The 3rd Enhancing Drug Formulation & Bioavailability conference brings together the industry’s leading formulation experts to share and discuss emerging drug bioavailability and solubility enhancement strategies.

Join Dr. Abhijit Gokhale, Senior Scientist, Formulation andProcess Development as he discusses Recent Advances in Latest Technologies forBioavailability Improvement of Pharmaceutical Drugs on Tuesday January 28that 5:50pm

http://www.exlpharma.com/bioavailability#.Umlsr_nrz94

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Jan
27
2014

Drug Delivery Partnerships

Drug Delivery Partnerships is the meeting place to discover innovative products, anticipate and take advantage of trends in the partnering landscape and implement best practices to ensure your company stays ahead of the curve.

Join Don Barbieri, Associate Director, Formulations and Process Development as he discusses Fixed Dose Combinations – Consideration is Product Life Cycle Management at the Innovation Theatre on January 28th at 2pm.

http://www.iirusa.com/ddp/welcome.xml

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Feb
17
2014

Drug Development and Formulation

It is estimated that by 2014 the global pharmaceutical industry will be worth over $910 billion. Europe will contribute around a third of this figure, ranking second to the North American market. Due to increased competition from the emerging markets, Europe has suffered in terms of growth post 2009 but still contributes 50%.

As the industry model moves further from that of the blockbusters, companies are under more pressure than ever to push new compounds through development in an effort to see a return on their investments. Europe has along standing and loyal consumer market, is home to an elite group of highly profitable pharmaceutical companies and has the technical expertise to drive its growth in this area.

http://www.ddfevent.com/

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Feb
20
2014

Texas Life Science Forum

The Texas Life Science forum is the annual life sciencegathering in Texas showcasing over 50 emerging companies, technologies andscientific developments to an audience of over 500 investors, industryexecutives, entrepreneurs and researchers from across the state.

Title of Panel: Virtual doesn’t mean absent: How to selectand manage your outsourced providers.

Speaker: Kevin Kane, PhD, Account Executive, Patheon

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Feb
26
2014

HPAPI World Congress 2014

HPAPI World Congress is the region’s leading event dedicated to process enhancement, technological innovation and business development.

HPAPI World Congress is an interactive 2 day event with multiple, disruptive learning formats and offers real practical outcomes around: 

·        High Potency API Development

.        High Potency Finished Product Manufacture

John McLaughlin to present on “Effective highly potent compound handling inCMOs” on 26 February

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Feb
26
2014

15th Clinical Trials Supply

The global pharmaceutical industry is embarking on a transformation journey in which the clinical supply chain will play a strategic change management role. Increased service requirements will require pharmaceutical companies to adapt their business models to accommodate market changes.

The challenges around; reduced costs, greater agility and improved speed to market – whilst ensuring the often complex regulatory legal framework in countries are being met – will form a turbulent operating landscape for companies in the industry.

http://www.arena-international.com/ctseurope

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Mar
03
2014

7th Annual European Life Sciences CEO Forum

The 7th Annual European Life Sciences CEO Forum, is being held on 4th-5th March 2014 at the Hilton Zurich Airport Hotel, Switzerland. This event will be highly transactional, bringing together an exciting cross-section of venture-funded and small-cap companies with leading investors, pharmas, and scientific thought leaders. We expect around 350 delegates and 80 presenting companies.

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Mar
10
2014

BioEurope Spring

BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing lifescience companies with high caliber partnering opportunities.

Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative start-ups.

http://www.ebdgroup.com/bes/index.php

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Mar
10
2014

2014 DCAT Week

Meet with us at the DCAT Week. This is one of the largest gatherings in the world
for the pharmaceutical and related industries.

You're cordially invited to the Patheon post-gala dinner reception at the Waldorf Astoria - 4th floor - Cole Porter Suite. See you there!

http://www.dcat.org/

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Mar
12
2014

CMO Leadership Awards Reception and Ceremony

Patheon will be recognized in 4 out of the 5 categories: Innovation, Productivity, Quality and Reliability.

http://www.cmoleadershipawards.com/index.php/en/

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Mar
17
2014

CHPA Annual Executive Conference

Through powerful keynote presentations and panel discussions, this Conference brings the latest self-care behavior trends, global perspectives on the OTC market, insights on big data and technology, visions of global power, and the impact of the Affordable Care Act.

http://www.chpa.org/AEC/

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Mar
18
2014

Interphex

Join us at Booth 1438 March 18-20, 2014 in New York City for the leading annual gathering of pharmaceutical and biopharmaceutical manufacturing professionals.

http://www.interphex.com/

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Mar
24
2014

Biopharmaceutical Development and Production Week

IBC's Biopharmaceutical Development & Production (BDP) Week event provides the most in-depth coverage of bioprocessing methods in the field, to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline.

http://www.ibclifesciences.com/BDPWeek/overview.xml

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Mar
24
2014

4th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems

Join us to witness and share your experiences with the world leaders from pharmaceutical and biopharmaceutical research rendering their expertise in pre-formulation, formulation and physiological approaches associated with pharmaceutical moieties.

Dr. Jason Vaughn, Director, Formulation and Process Development as he presents on preformulation considerations for solid and semisolid dosage forms.

http://pharmaceutica2014.pharmaceuticalconferences.com/

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Apr
02
2014

BiosimilarDrug Development World

The 3rd annualBiosimilar Drug Development World Europe provides true insight on the bestdevelopment, manufacturing, clinical and commercialisation strategies forbiosimilars in the global market

http://www.healthnetworkcommunications.com/conference/biosimilar-drug-development-world-europe/

 

 

 

 

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Apr
02
2014

BioProcess International European Conference and Exhibition

Connecting innovations in upstream, downstream, analytics and formulation to accelerate process development, improve product quality and prepare for increasingly diverse pipelines.

http://www.informa-ls.com/event/Bpi2014

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Apr
07
2014

2014 PDA Annual Meeting

Join us at Booth 309 at the PDA Annual Meeting.

The theme for the meeting is “Biopharmaceutical and Sterile Pharmaceutical Manufacturing – Embracing Innovation to Meet Global Challenges.

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Apr
09
2014

CPhI / iCSE Japan 2014

2014年4月9日[水]~11日[金]に東京ビックサイトで開催される国際医薬品材料・中間体展での製造業界受託サービスエキスポに出展致します。展示ブースはJ-04番となっております。

また、今回はパセオンのエキスパートによる出展者プレゼンテーションを下記の内容にて行いますので、是非ご参加いただきますようお願い申し上げます。

4月9日(16:00-16:45)

Title: Strategies forDeveloping Sterile Dosage Forms

4月10日(13:45-14:15)

Title: QbD – A Contract Manufacturers Perspective andExperience. Application to the new Process validation guidance strategy.

詳細はこちら

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Apr
09
2014

CPhI / iCSE Japan 2014

CPhI Japan and co-located events ICSE, P-MEC,BioPh, and Pharmatec are the ultimate one-stop-shop for all pharma relevantactivity concerning Japan. The following Exhibitor’s presentation will bepresented by Patheon’s experts during this tradeshow.

April 9 (16:00-16:45)

Title: Strategies forDeveloping Sterile Dosage Forms

April 10 (13:45-14:15)

Title: QbD – A Contract Manufacturers Perspective andExperience. Application to the new Process validation guidance strategy.

http://www.cphi.com/japan/home#sthash.xoQfwH5u.dpuf Read More

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Apr
09
2014

Nicholas Hall's INSIGHT 25th European OTC Conference & Action Workshop

Celebrating 25 years of informative and inspiring events, Nicholas Hall's INSIGHT European OTC Conference focuses on iNNOVATION as a theme this year. During this three-day event, the speakers will navigate you along the many paths to iNNOVATION, with topical presentations from Nicholas Hall and industry experts.

http://www.nicholashall.com/events/detail/nicholas-halls-insight-european-otc-conference-and-action-workshop-2014/

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May
06
2014

Vitafoods Europe

Vitafoods Europe is the leading ingredients and raw materials event for the nutraceutical, dietary supplements and functional food and drinks industries.

http://www.vitafoods.eu.com/

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May
12
2014

FCE Pharma

FCE Pharma focuses on the production chain in the pharmaceutical sector, especially the phases of manufacture, supply and distribution of products and services.
FCE Pharma attracts a qualified public of professionals associated with the pharmaceutical industry, suppliers, distributors and dealers of the counrty. The ideal spot for business in the pharmaceutical industry offering a vision of the future, product innovations, equipment and services, all in one place.             

http://www.fcepharma.com.br/en/

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May
12
2014

BioTrinity

BioTrinity is the premier European Biopartnering and Investment Conference, partnering R&D companies with big pharma and more biomedical investors than any other key European partnering conference.

http://www.biotrinity.com/silverstripe/

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May
14
2014

Biotech 2014 Japan

Gathering 603 exhibitors and 10,362 visitors in 2013, BIOtech Japan is Asia's LARGEST industry gathering. 650 exhibitors and 15,000 visitors are expected in 2014!

http://www.bio-t.jp/en/

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May
19
2014

AAPS National Biotechnology Conference

One Conference—Four Conference Workstreams:

• Biomanufacturing

• Biomarker and PK/PD

• Research and Discovery

• Immunogenicity and Administration Routes

The scientific programming at the 2014 National Biotechnology Conference will feature symposia, roundtables, sunrise sessions, short courses, and workshops.

https://www.aaps.org/nationalbiotech/

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May
20
2014

Clinical Trial Supply West Coast

The conference aims to bring together senior-level professionals on the West Coast, providing a fantastic platform to share ideas with your industry peers and take part in in-depth discussions. The program contains some key presentations from top industry specialists along with the opportunity to network and take part in round table discussions focused on present challenges faced by the industry. The event is tailored specifically to the West Coast and is a fantastic opportunity to meet your industry peers.

http://www.arena-international.com/ctswest/

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May
20
2014

IATI

IATI is Israels umbrella organisation representing the various constituents of the nations advanced technologies, be it high-tech, biomed, multi-national corporations, start-ups, incubators, accelerators, service providers and more.

http://www.iati.co.il/event-item/411/iati-israel-innovation-conference

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Jun
03
2014

50th AESGP Annual Meeting

AESGP is celebrating its 50th anniversary.

Self care has evolved exponentially in the past 50 years with new ingredients, products and practices, and is now well recognised as a fundamental building block for the delivery of care in advanced health care systems.

Reminding the milestones along the way, the 50th AESGP Annual Meeting, organised in conjunction with the 18th WSMI General Assembly, gathers together the consumer healthcare sector and provides a forum for discussion on the exciting developments expected in the future for self care in Europe and the world.

http://www.aesgp.eu/events/London50/

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Jun
11
2014

PharmaOutsourcing and Procurement

The Pharma Outsourcing & ProcurementSummit addresses the urgent need for the pharmaceutical industry to identifyand locate the best pharmaceutical outsourcing partnerships and solutions tostay competitive in an uncertain climate whilst addressing heightenedregulatory pressures and need to maintain high quality standards.

http://www.outsourcingevent.com/

 

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Jun
12
2014

BOS cmc

Welcome to Biotech Outsourcing Strategies cmc 2014 the CMC focused event for outsourcing professionals in the pharma, biotech and contract services community.

Now in our 7th consecutive year BOS cmc is a popular forum for R&D CMC professionals to meet, network and discuss best practice in CMC outsourcing! With a programme including small molecule and biologics tracks and a strong enthuses on virtual drug development, BOS cmc has been created withthe specific needs of the virtual biotech/pharma in mind. For our CMO sponsors BOS cmc provides a unique partnering event exclusively focused on CMC outsourcing. Join us in Copenhagen to brush up on skills, meet new business partners and network all in a friendly, welcoming environment.

http://www.bio2bevents.com/forthcoming-events/boscmc2014

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Jun
23
2014

Bio International Convention

The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry.

http://convention.bio.org/

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Jul
02
2014

Interphex Japan

Covering the whole process of Pharmaceutical R&D and Manufacturing (from all kinds of equipment, lab devices, contract services, packaging to other total solutions), INTERPHEX JAPAN is firmly established as the one and only business platform where the whole Japanese pharmaceutical industry gets together.

http://www.interphex.jp/en/

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Jul
13
2014

Controlled Release Society Annual Meeting

There is no better meeting for reaching the influential and international drug delivery and delivery science audience.

http://www.controlledreleasesociety.org/meetings/annual/Pages/default.aspx

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Aug
18
2014

Bioprocessing Summit

The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line selection to bioproduction. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.

This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor waterfront. Hundreds of bioprocess professionals come together each year at the Summit to share practical solutions for today’s laboratory challenges with researchers from around the world.

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Sep
02
2014

Prefilled Syringe Summit

Prefilled Syringe Summit 2014 is where you can share knowledge and expertise with your peers to find solutions to specific challenges facing the industry. Attend and gain clarity on regulatory guidelines, identify innovative PFS design features and optimize your fill/finish process. Learn from, and network with, the most senior industry experts from pharma, biotech, CMOs and PFS manufacturers in an open and focused setting rarely experinced by the field.

http://prefilled-syringes.com/

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Sep
09
2014

CHPA Market Exchange

CHPA offers annual meetings and conferences, as well as periodic seminars, workshops, and webinars on topics of importance to the consumer healthcare products industry.

http://www.chpa.org/MX/

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Sep
18
2014

13th Annual Contracting & Outsourcing Conference

Contract Pharma magazine is holding its 13th Annual Contracting & Outsourcing Conference & Tabletop Exhibition, devoted to outsourcing in the pharma and  biopharmaceutical industries. The event will be held on September 18-19, 2014 in the heart of New Jersey's pharmaceutical industry. Stop by the Patheon table to speak with a representative and learn more about our pharma outsourcing capabilities.

http://conference.contractpharma.com/ 

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Sep
23
2014

Biotech Outsourcing Strategies 2014

Biotech Outsourcing Strategies (BOS) is a popular forum for R&D professionals to meet, network and discuss best practise in R&D outsourcing.  With two parallel tracks covering Discovery/Early Development Outsourcing and Clinical Operations Outsourcing you can be confident that our high quality speaker programme will cover your specific area of outsourcing interest. With a strong emphasis on the challenges faced by the virtual outsourcing model BOS will be particularly relevant to biotech and pharma evolving toward (or already operating) a virtual or semi virtual R&D operation.

http://www.bio2bevents.com

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Sep
24
2014

BioSpain

Jointly organized in its 6th edition by the Spanish Bioindustry Association (ASEBIO), SPRI (Government of the Basque Country) and the BioBasque agency, Biospain 2012 has become one of the leading biotech events in Europe, being the perfect setting for forging new partnerships and strengthening existing business relationships in the biotechnological market.

http://www.biospain2014.org/

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Oct
07
2014

CPhI Worldwide

The world's leading pharmaceutical networkingevent, co-located with ICSE, P-MEC and InnoPack and hosting over 34,000attendees from 140 countries and 2,200 exhibitors.
Meet face-to-face with international pharmaceutical companies, stay informedabout the latest industry trends and remain one step ahead of a constantlychanging pharmaceutical market.

http://www.cphi.com/Europe/home

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Oct
14
2014

PODD - Partnerships in Drug Delivery

The Conference Forum is delighted to present the 4th Annual PODD, Partnership Opportunities in Drug Delivery event. This annual Boston based conference is designed with three purposes:

  1. To present a strategic level program for pharma and biotech business development professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and opportunities to improve therapies and extend the life cycle of a drug.
  2. To provide drug delivery and specialty pharmas with a platform to present their technologies and get the latest insights on what the delivery and formulation needs are.
  3. To offer ample networking time, facilities and services for one-on-one meetings to establish new business contacts and enhance existing ones.

http://theconferenceforum.org/conferences/partners-in-drug-delivery/overview/

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Oct
20
2014

BioProcess International

This year’s BioProcess International Conference & Exhibition will be held in Boston, MA. The conference is ranked the #1 BioProcessing event by the industry and the Patheon team is excited to be attending. BPI attracts experts from all bioprocessing and biomanufacturing disciplines and all levels, from research scientist to group leader to senior level executive who share and discuss their challenges in an interactive, learning environment. We hope to see you at our Booth #701!

http://www.ibclifesciences.com/BPI/overview.xml


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Oct
26
2014

World ADC San Diego

World ADC San Diego has been designed to dramatically enhance your ADC research and development efforts. Providing access to expert intelligence on how to select your lead candidate with confidence, improve preclinical predictability and maximize clinical efficacy, the 2014 program cannot be missed.

This year, 65+ amazing speakers and over 550 of the global network of ADC developers will distil 12 months of learning into 4 jam packed days of insight and intelligence. Join us to improve your programs and be part of the mission to develop better ADC drugs.

http://adc-summit.com

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Oct
29
2014

AusBiotech 2014

AusBiotech conference is held annually to inform and update the biotechnology sector with current industry facts and knowledge.  It provides key presentations and forums to help bring together representatives and professionals from across the biotechnology industry and the globe to experience a comprehensive conference program, extensive bio-industry exhibition, business matching program and associated events such as the AusFoodtech Symposium.

http://ausbiotechnc.org

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Nov
02
2014

2014 AAPS Annual Meeting

Plan now for the meeting that extends your boundaries.

Schedule a Meeting with Patheon!

  • Widen your personal network with scientists from all fields related to pharmaceutical sciences.
  • Explore programming including Hot Topics covering both large and small pharma.
  • Find the latest advances with more than 2,500 contributed papers.

https://www.aaps.org/annualmeeting/


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Nov
03
2014

BIO-Europe® Conference

BIO-Europe® is Europe's largest partnering conference serving the global biotechnology industry. The conference annually attracts leading dealmakers from biotech, pharma and finance along with the most exciting emerging companies. Produced with the support of BIO, it is regarded as a “must attend” event for the biotech industry.

Featuring EBD Group's sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative start-ups.

http://www.ebdgroup.com/bioeurope

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Nov
10
2014

Outsourced Pharma West

Outsourced Pharma West Conference & Exhibition will engage pharmaceutical and biopharmaceutical executives who form and manage partnerships for development and manufacturing. The program includes interactive panels on drug development and partnering led by done-it-before executives, informal networking receptions, and an exhibition showcase of services providers. Presented in its inaugural year by Life Science Leader magazine, BayBio, and OutsourcedPharma.com.

http://baybio.org/outsourced-pharma-west

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Jan
28
2015

Drug Delivery Partnerships Conference

As the longest running conference of its kind, Drug Delivery Partnerships (DDP) is hailed by all as the world's most authoritative conference on collaboration to drive progress in drug delivery, with attendees from nearly 30 countries and 40 U.S. states. DDP is where you discover innovative products, take advantage of trends, and jumpstart strategic relationships to leap ahead of the curve.

http://www.iirusa.com/ddp/welcome.xml


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Apr
08
2014

Recorded WEBCAST on Challenges in the Development of Active Drug-layered Formulations

Active drug layering provides tremendous opportunities in the development of immediate-release dosage forms of a single drug entity or fixed-dose combination drugs. The technique also has been widely used to develop modified-release dosage forms as a monolithic system or as multiparticulates with a possibility of targeting the release to a specific region of the gastrointestinal tract. The development of an active drug-layered formulation can pose challenges based on properties of the API, dose, processing parameters, target release profiles required, and other factors. The webcast discusses applications of this technique, development considerations, manufacturing and analytical challenges, and case studies.

Speakers: Don Barbieri, Terri Williamson, Robert Diehl

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May
23
2014

Recorded WEBCAST on Life Cycle Management Opportunities in Softgel Technologies

Drug delivery technology based on the softgels is widely accepted as preferred dosage form in the consumer healthcare, and is recognized as an interesting life cycle opportunity for pharmaceutical products. One such opportunity is the development of dosage forms for specific populations, like pediatrics, although this area of formulation development is relatively uncovered and novel. The European Medicines Agency has stated: “The joint goal for industry, regulators, practitioners and patients is to encourage pediatric drug development in order to create a situation where substantially more children have access to safe and effective medication…”.

The webinar will present the benefits and limitations offered by Chewels™ as a pediatric dosage form through an actual case study of an approved generic application of a chewable softgel. Formulation options, manufacturing, and regulatory aspects will be discussed, with relevant subjects like pediatric guidelines, cross linking of gelatin and regulatory perception, bioequivalence approach, and general feedback on the dosage form by health authorities during the registration process.

Speakers:

Kaspar van den Dries - Senior Director Formulation Sciences Solid Dose and Softgels, Patheon

Katja van Eijndhoven - Regulatory Affairs Manager, Banner Life Sciences

Register Here

Jun
11
2014

Recorded WEBCAST on Lyophilization Cycle Design and Scale Up

Recorded Webcast: Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles

Lyophilization or freeze drying is a well established process in manufacturing of sterile injectable products. The Lyocycle involves freezing, primary drying and secondary drying. Development of a lyo cycle and understanding of heat and mass transfer under different load conditions is critical in development of a robust lyophilization process.

The webinar will focus on establishing a lyophilization scale- up model that is aimed to demonstrate the full scalability between lab and production lyo in order to allow to perform the development or optimisation of a freeze-drying cycle in the pilot freeze dryer with significant cost savings.

Speakers:

Enrico Corona, Formulation and Production Manager, Patheon
Ronald Pate, Lyophilization Scientist, Customer Project Support, Patheon

Jun
24
2014

Recorded WEBCAST on QbD Strategies for Successful Drug Product Formulation

Recorded WebcastQbD Strategies for Successful Drug Product Formulation

Quality-by-Design (QbD) is a strategic approach that helps companies achieve higher process understanding, enhanced control, better product quality, increased data for continuous improvement and potential for reduced FDA approval times. Implementing a robust QbD strategy allows Pharma, Biotech and contract service providers to build leaner processes and achieve the ultimate goal for successful product development and manufacturing.

This live webinar examines the opportunities in QbD projects, including the hurdles in implementing QbD from a contractors’ perspective. Join us to discover how to define a successful strategy and execute a systematic scientific plan to overcome challenges and meet regulatory requirements.

Speakers

Anil Kane Ph.D. MBA, Global Head of Formulations, Patheon
Steve Closs, Director, Global Technical Affairs, Patheon

Jul
17
2014

Recorded WEBCAST - Analytical Challenges & Case Studies in Method Dev. for Fixed-Dose Combinations

Recorded Webcast: Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations

Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug’s efficacy and improve patient compliance. Pharmaceutical companies are turning to these fixed-dose combinations to maximize product value and expand a product’s lifecycle. 

In this webcast, experts will discuss challenges and solutions for the development of analytical methods associated with fixed-dose combinations. Case studies will demonstrate the complexities involved with analyzing these dosage forms. 

Speakers:

Gordon Marr, PDS Analytical Development
Maureen McLaughlin, Analytical Chemist
Yue Chen, PDS Analytical Development

Sep
16
2014

Recorded WEBCAST on Applying single-use technologies in Biopharmaceuticals

Recorded Webcast: Applying single-use technologies in Biopharmaceuticals to achieve Supply Chain Excellence

Single-use technologies have revolutionized manufacturing operations in the biopharmaceutical industry, for both drug substance and drug product. While they are now commonly used for production of clinical trial material, new flexible facility design incorporating single-use technologies can also enable more efficient commercial manufacturing of monoclonal antibodies and other biopharmaceutical products. 

This live session will feature case studies showcasing the application of single-use technologies to drug substance and drug product manufacture.

Webinar highlights:

• Capacity increases and how they were realised due to the introduction of single-use technologies
• Extractables and leachables strategies
• Product development strategy and the use of single-use technologies
• Flexible manufacturing facilities and how to reduce footprint
• Technological possibilities for increased supply of commercial quantities of biopharmaceuticals

Speakers: 

Tony Pidgeon, Director, Applied Technology Finished Dose, Patheon
John McGuire, Director, Applied Technology, Biologics API – EMEA/APac, Patheon

Sep
17
2014

Recorded WEBCAST on API Characterization for a Speedy and Successful Formulation Strategy

Recorded Webcast: API Characterization for a Speedy and Successful Formulation Strategy

The physicochemical properties of the API in a solid state are extremely important as they affect the choice and design of formulation as well as the performance of the dosage form. A robust solid-state characterization of the API at an early stage helps drug developers better understand the properties of the API and the effect these characteristics have on the drug behavior, especially on uniform distribution, solubility, stability, and its in-vitro dissolution and bioavailability. This information impacts formulation and development decisions. In this webinar, experts examine key API properties and their impact on formulation design and development decisions.

In this webinar, experts examine key API properties and their impact on formulation design and development decisions.

Speakers: 

Anil Kane Ph.D. MBA, Executive Director, Global Formulation Sciences, PDS
Friedrich Brandl, Quality Manager, DSM Pharma Chemicals, Regensburg (ResCom®)

Mar
14
2012

WEBCAST A Quality by Design (QbD) Approach to Monoclonal Antibodies Formulation and Lyophilization

Monoclonal antibody formulation and lyophilization process development offer unique challenges based each individual molecule. Unexpected results can result in costly delays and significant formulation problems later in the development cycle. Applying Quality by Design(QbD) practices to formulation and development processes, early in the development cycle can lead to achieving development milestones faster and with more predictable results. This 60-minWebcast will offer insight from leading industry experts on QbD approaches to improve monoclonal antibody formulation and lyophilization process development. Gain insight into how development challenges can be minimized using QbD practices at the earliest stages of development.

Roman Hlodan,PhD, Biopharmaceutical Specialist at Patheon, will discuss QbD approaches to monoclonal antibodies formulation.

EnricoCorona, Formulation and Process Development Manager at Patheon, will present methods to include QbD processes for lyophilization cycle development.

Register Here

Jun
12
2012

Recorded WEBCAST on "When Softgels Are a Good First Option: Overcoming Bioavailability Challenges"

The tablet is the most common drug formulation on the market, but is it always the best choice to improve bioavailability? In many cases, current drugs would have performed better as softgels. Understanding when to leverage the advantages of softgel technology could save crucial time and resources in development and manufacturing in addition to offering the benefits of finally obtaining a better absorption and formulating a better product than the same tablet.  During this 60 minute webcast, learn how softgel technology can be used to solve poor bioavailability challenges. Through case studies and analysis, two leading industry experts will provide an introduction to softgel technology and case studies where softgels have proven to be better.

What is Different about Soft Gelatin Capsules?

Diego Monterroza, Director of Research and Development at PROCAPS S.A., one of the world’s largest softgel manufacturers. In his presentation, Diego will provide an introduction to softgels including gelatin properties,advantages of softgel capsules, the manufacturing process, formulation, and quality controls.

Softgel Delivery Can Improve Drug Bioavailability

Edgar Jaynes, Associate Director, Liquid Fill Softgel, Pharmaceutical Development Services at Patheon, a leading global provider of contract development and manufacturing services. In his presentation, Edgar will review current Rx sofgels on the market, discuss bioavailability concerns, and provide case study examples of bioavailability enhancement using softgel formulations, including Cyclosporin, Digoxin, Dutasteride, Isotretinoin, Progesterone, and Saquinavir.

Register Here

Jul
26
2012

Recorded WEBCAST on "Unlocking the Power of New Softgel Technology for Multiple API Formulations"

Historically, tablets have been the go-to formulation for products with multiple active ingredients. However, new softgel technology is emerging and challenges traditional formulation paradigms with innovative solutions to multiple API products and unique dosing regimens.

 

In this 60 minute webcast, two scientific experts in tablet and softgel formulation development, will examine the traditional approaches to multiple API product formulations and will introduce unique softgel technologies that overcome challenges faced with difficult-to-develop, multiple API products. These unique softgel technologies can be used for life cycle management, create lower-cost products, and enable combinations of multiple delivery systems in a single, patient centric  dose, including: 

 

•      Multiple active ingredients

•      Incompatible materials with different release profiles

•      Liquids, granules, solids and hard capsules

•      Fast and sustained release

•      Gastric and intestinal release

Register Here

Sep
01
2012

RECORDED Overcoming Challenges in Complex Formulation Development:Bilayer Tablets & Beads-in-Capsule

Choosing the right formulation for a molecule is a challenging process. Whether you are looking to extend the life-cycle of a drug or handling complicated APIs, there are multiple formulation options available for solid dose forms. Knowing which formulation will deliver the optimal bioavailability is crucial to a drug’s eventual success.  For example, how do you develop a fixed dose formulation that ensures the compatibility of multiple APIs with differen tprofiles?  This 60-minute webcast will provide answers to questions like this through case-study analysis and insight from leading industry experts on formulation-development strategies in product life-cycle management, including specialized formulations such as bilayer tablets and beads-in-capsules.

Anil Kane, Ph.D, MBA, Executive Director, Global Science & Technology, Pharmaceutical Development Services at Patheon will discuss bilayer tableting challenges and solutions.

Ram Kasina Ph.D, Senior Director-Formulation and Process Development at Patheon will discuss beads in capsule formulation development challenges.

Register Here

 

Sep
19
2012

Recorded WEBCAST on "Optimizing Controlled Release: The Use of Osmotic Oral Delivery Systems"

Several formulation design options are available to control or modulate the drug release from a dosage form. The majority of oral dosage forms fall in the category of matrix, reservoir, or osmotic systems. In a hydrophilic matrix system, the drug is embedded in a polymer matrix and the release takes place by diffusion of the drug into the hydrated polymer gel layer and erosion of the gel layer into the release medium. In contrast, reservoir systems have a drug core surrounded or coated by a water-insoluble, but permeable rate-controlling membrane. However, factors such as pH, the presence of food, and other physiological factors may affect drug release from conventional, matrix and reservoir controlled-release systems. Osmotic systems utilize the principle of osmotic pressure for the delivery of drugs. Drug release from these systems is independent of pH and other physiological parameters to a large extent, making it possible to modulate the release characteristic by optimizing the properties of drug and the coating system.  In this 60 minute webcast, two scientific experts in formulation development of oral osmotic release dosage forms, will speak on

  • Theory and basic formulation principles of oral osmotic release systems
  • Advantages over other conventional release systems
  • Recent advances in osmotic delivery
  • Case Studies

Basic Formulation/Scale-up Considerations and the Theory behind Oral Osmotic Systems – Don Barbieri, Patheon, Inc

 

Recent Advances in Osmotic Delivery – Elizabeth Tocce, Dow Chemical Co.


Mar
06
2013

Recorded WEBCAST Accelerate Sterile&Non-Sterile Clinical Trial Manufact. w/Single-Use Technologies

Pharmaceutical products manufactured with non-dedicated equipment are always at risk of being contaminated with traces of the previous product manufactured. This risk is reduced by costly and time-consuming equipment cleaning regimes and cleaning verification/validation programs. Single-use disposable systems eliminate the risk of cross-contamination and reduce time and costs while meeting safety requirements for clinical trial scale batches.

This 60-minute webcast will focus on how single use technologies improve the economics of manufacturing clinical trial supplies for both sterile and non-sterile products. While single-use disposable technologies have been widely adopted for sterile products, they have been less-often used for non-sterile products, but are equally effective and can lead to additional time saving programs for phase I clinical trial materials. Through case studies, two industry leaders will demonstrate the benefits and limitations of single-use disposable systems, focusing on:

  • Single-use systems for sterile product manufacturing
  • Single-use systems for tablet and capsule manufacturing
  • Extractables and leachables
  • Additional time saving techniques
                   

Register Here

             


May
02
2013

Recorded WEBCAST on "A Pragmatic Application of QbD: Turning Theory into Tangible Success"

A well-designed Quality by Design (QbD) approach to drug development and manufacturing can substantially minimize development and scale-up challenges and increase the reliability of the manufacturing process. While a wealth of information exists on the theory behind QbD, there is no “one size fits all” application of it. For a project to reap the added benefits of quality and robustness resulting from QbD, it is critical to understand how to use some of the QbD tools to identify and control the factors contributing to product variability. For example, reduced product variability from QbD can lead to cost savings as a result of decreased batch failure during routine manufacture.

During this 60-minute webcast, two industry experts will share case studies and their experience with QbD and offer insight into how the practical application of QbD contributed to the success of their projects — steps that can be universally applied to your projects.

Don Barbieri, associate director of formulation and process development, Patheon, will present case studies demonstrating different aspects of the QbD approach, including identifying CQAs (critical quality attributes) and CPPs (critical processing parameters) as well as risk assessment determination, risk mitigation, DoE, and more.

David Smith, pharmaceutical specialist, formulation and process development, Patheon, will present a case study where the pragmatic application of QbD enabled a successful tech transfer of a film-coated tablet from Phase III to commercial scale.

Register Here

May
15
2013

Recorded WEBCAST on Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes

Trends in Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes

In the pharmaceutical industry, an increasing number of new drug candidates are considered “highly potent”, which can have significant impact on how they can be safely handled in drug product development and manufacturing.This webcast explores what the term “highly potent” means and discusses what is required to manufacture these drugs from an equipment containment perspective.The main focus will be on the safe handling of these drugs (e.g. safety of equipment operators). However, these principles also apply to meeting Good Manufacturing Practices (GMP) requirements for minimizing cross-contaminationto other drugs manufactured in the same facility. The use of control banding, a procedure for assigning an active pharmaceutical ingredient to a potent or non-potenthazard category corresponding to an airborne concentration range, will also be discussed. Two case studies that are designed to highlight the key take home messages of this session will be presented.

Marvin Faber, PhD, DOHS, CRSP - Sr. Director, Global Head EH&S at Patheon: “Overview of Safe Potent Compound Handling”

Giuseppe Galati, PhD - Manager, Toxicology Services Corporate Environmental, Health & Safety at Patheon: “Toxicological Principles of Banding”

Jeff Dinyer – Director, Environment, Health and Safety, North America and Global High Potency at Patheon: “Containment Trends and Practices

Register Here

May
15
2013

WEBCAST on "Trends in safe handling of potent compounds in pharmaceutical manufacturing processes"

In the pharmaceutical industry, an increasing number of new drug candidates are considered “highly potent”, which can have significant impact on how they can be safely handled in drug product development and manufacturing. This webcast explores what the term “highly potent” means and discusses what is required to manufacture these drugs from an equipment containment perspective. The main focus will be on the safe handling of these drugs (e.g. safety of equipment operators). However, these principles also apply to meeting Good Manufacturing Practices (GMP) requirements for minimizing cross-contamination to other drugs manufactured in the same facility. The use of control banding, a procedure for assigning an active pharmaceutical ingredient to a potent or non-potent hazard category corresponding to an airborne concentration range, will also be discussed. Two case studies that are designed to highlight the key take home messages of this session will be presented.

Marvin Faber, PhD, DOHS, CRSP - Sr. Director, Global Head EH&S at Patheon: “Overview of Safe Potent Compound Handling”

Giuseppe Galati, PhD - Manager, Toxicology Services Corporate Environmental, Health & Safety at Patheon: “Toxicological Principles of Banding”

Jeff Dinyer – Director, Environment, Health and Safety at Patheon: “Containment Trends and Practices”

 

Register Here

           

 

Jun
04
2013

Recorded WEBCAST Cleaning Validation: Science, Risk, and Novel Approaches to Testing

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:

• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.

Speakers:
Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

REGISTER HERE

Jun
04
2013

Recorded WEBCAST "Cleaning Validation: Science, Risk, and Novel Approaches to Testing"

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:

• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.
Speakers:

Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

Register Here

Jun
04
2013

Recorded WEBCAST on "Cleaning Validation: Science, Risk, and Novel Approaches to Testing"

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:

• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.

Speakers:

Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

Register Here

Jun
04
2013

Recorded WEBCAST Cleaning Validation: Science, Risk, and Novel Approaches to Testing

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:

• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.
Speakers:

Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

REGISTER

Jun
04
2013

Recorded WEBCAST Cleaning Validation: Science, Risk, and Novel Approaches to Testing

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:

• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.
Speakers:

Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

REGISTER

Jun
05
2013

Recorded - WEBCAST - Cleaning Validation: Science, Risk, and Novel Approaches to Testing

All pharmaceutical manufacturers are required to comply withregulations for cleaning validation. Many companies have incorporated theirhistorical practices with limited scientific underpinning and little evaluationof risk. Some companies have chosen to avoid the debate entirely by usingexpensive disposable systems exclusively. Using the latitude available in cGMPsfor 21st century, scientific data evaluation, and risk-based approaches canstreamline the process. By developing sound and defensible programs with rapidand specific testing, cleaning validation can be efficiently and effectivelyimplemented. This webcast will:

• introduce thescience-driven risk-based guide for cleaning validation being developed byISPE;
• discuss practical considerations for implementing cleaning validationprograms; and
• highlight the speed and efficiency benefits of LC/MS for development andexecution of cleaning test methods.

Speakers:


Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE CleaningGuide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

Read More

Jun
11
2013

Recorded WEBCAST Accelerating the Drug Development Trajectory by improving Solubility of Coumpounds

Move your product development rapidly, achieving agreed timelines at fixed budgets and with minimal API.

This webinar offers a roadmap to understanding and overcoming solubility issues in Phase I clinical trials. We will discuss how companies can drastically improve solubility to optimize drug development timelines and get regulatory approval faster.

Watch this webinar and learn about:

  • Streamlining First in Man formulation development programs
  • Solubility / bioavailability enhancement
  • Formulation strategies for Phase I for soluble and poorly soluble molecules
  • SoluPathTM - fixed price, multiplatform solution to improve bioavailability

Speakers:

Robin Platt, Operations Director, Milton Park, UK, Patheon

Jason Vaughn, rector of Formulation and Product Development, Cincinnati, US, Patheon

REGISTER

Jun
11
2013

Recorded WEBCAST Accelerating the Drug Development Trajectory by improving Solubility of Compounds

Move your product development rapidly, achieving agreed timelines at fixed budgets and with minimal API.

This webinar offers a roadmap to understanding and overcoming solubility issues in Phase I clinical trials. We will discuss how companies can drastically improve solubility to optimize drug development timelines and get regulatory approval faster.

Attend this webinar and learn about:

  • Streamlining First in Man formulation development programs
  • Solubility / bioavailability enhancement
  • Formulation strategies for Phase I for soluble and poorly soluble molecules
  • SoluPathTM - fixed price, multiplatform solution to improve bioavailability

Speakers:

Robin Platt - Operations Director at Patheon, Milton Park, UK

Jason Vaughn - Director of Formulation and Product Development at Patheon, Cincinnati, US

Register Here

Jun
11
2013

Recorded WEBCAST celerating the Drug Development Trajectory by improving Solubility of new Compounds

Move your product development rapidly, achieving agreed timelines at fixed budgets and with minimal API.

This webinar offers a roadmap to understanding and overcoming solubility issues in Phase I clinical trials. We will discuss how companies can drastically improve solubility to optimize drug development timelines and get regulatory approval faster.

Watch this webinar and learn about:

  • Streamlining First in Man formulation development programs
  • Solubility / bioavailability enhancement
  • Formulation strategies for Phase I for soluble and poorly soluble molecules
  • SoluPathTM - fixed price, multiplatform solution to improve bioavailability

Speakers:

Robin Platt - Operations Director, Milton Park, UK, Patheon

Jason Vaughn - Director of Formulation and Product Development, Cincinnati, US, Patheon

REGISTER
Patheon

Jun
18
2013

Recorded WEBCAST Accelerating the Drug Development Trajectory by improving Solubility of new Compoun

Move your product development rapidly, achieving agreed timelines at fixed budgets and with minimal API.

This webinar offers a roadmap to understanding and overcoming solubility issues in Phase I clinical trials. We will discuss how companies can drastically improve solubility to optimize drug development timelines and get regulatory approval faster.

Watch this webinar and learn about:

  • Streamlining First in Man formulation development programs
  • Solubility / bioavailability enhancement
  • Formulation strategies for Phase I for soluble and poorly soluble molecules
  • SoluPathTM - fixed price, multiplatform solution to improve bioavailability

Speakers:

Robin Platt, Ph.D., Operations Director of Patheon's Milton Park site in the UK

Jason M. Vaughn Ph.D., Director of Formulation and Product Development at Patheon Cincinnati.

Jun
18
2013

Recorded WEBCAST Cleaning Validation: Science, Risk, and Novel Approaches to Testing

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:

• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.
Speakers:

Andrew Walsh

Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”

Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”

REGISTER HERE

Jun
18
2013

Recorded WEBCAST Accelerating Drug Development Trajectory by improving Solubility of new Compounds

Move your product development rapidly, achieving agreed timelines at fixed budgets and with minimal API.

This webinar offers a roadmap to understanding and overcoming solubility issues in Phase I clinical trials. We will discuss how companies can drastically improve solubility to optimize drug development timelines and get regulatory approval faster.

Watch this webinar and learn about:

  • Streamlining First in Man formulation development programs
  • Solubility / bioavailability enhancement
  • Formulation strategies for Phase I for soluble and poorly soluble molecules
  • SoluPathTM - fixed price, multiplatform solution to improve bioavailability

Speakers:

Robin Platt,
Operations Director, Milton Park, UK, Patheon

Jason Vaughn
Director of Formulation and Product Development, Cincinnati, US
Patheon

REGISTER HERE

Jul
18
2013

WEBCAST on Overcoming Challenges in Development of Oral Enteric and Controlled-Release Dosage Forms

Enteric-coated dosage forms are designed to resist the destructive action of gastric fluid and to disintegrate in the higher pH environment of the intestinal fluid. This need may arise if the API degrades upon exposure to an acidic environment or causes irritation of the gastric mucosa. The complexity of developing a controlled-release dosage form increases for drug molecules that possess narrow therapeutic windows, and where absorption site is in the upper or lower part of the small intestine and/or colon. Some small and large molecules further need solubility/permeability enhancement at the intestinal pH range while others need to be protected from moisture in solid dosage form, thus requiring multiple layers of coating – enteric, moisture barrier, controlled-release, etc.

During this 60-minute interactive webcast, three industry experts will discusses challenges and case studies in the development of enteric and controlled-release properties in a variety of solid dosage form ssuch as multi-particulate, tablets, capsules, and softgels.

Speakers:

Anil Kane, Ph.D., Executive Director, Global Formulation Sciences, PDS, Patheon
Nazaneen Pourkavoos, Ph.D. , Director, Formulation Development, Patheon, High Point
Jason M. Vaughn, Ph.D., Director, Formulation and Product Development, Patheon, Cincinnati

Register

Jul
22
2013

Recorded WEBCAST Overcoming Challenges in Development of Oral Enteric and Controlled-Release Dosage

Recorded Webcast: Overcoming Challenges in Developmentof Oral Enteric and Controlled-Release Dosage Forms

Enteric-coated dosage forms are designed to resist the destructive action of gastric fluid and to disintegrate in the higher pH environment of the intestinal fluid. This need may arise if the API degrades upon exposure to an acidic environment or causes irritation of the gastric mucosa. The complexity of developing a controlled-release dosage form increases for drug molecules that possess narrow therapeutic windows, and where absorption site is in the upper or lower part of the small intestine and/or colon. Some small and large molecules further need solubility/permeability enhancement at the intestinal pH range while others need to be protected from moisture in solid dosage form, thus requiring multiple layers of coating – enteric, moisture barrier, controlled-release,etc.

During this 60-minute interactive webcast, three industry experts will discuss challenges and case studies in the development of enteric and controlled-release properties in a variety of solid dosage forms such as multi-particulate, tablets, capsules, and softgels.

Speakers:

Anil Kane, Ph.D., Executive Director,Global Formulation Sciences, PDS, Patheon
Nazaneen Pourkavoos, Ph.D. , Director, Formulation Development, Patheon, High Point
Jason M. Vaughn, Ph.D., Director, Formulation and Product Development, Patheon, Cincinnati

Sep
11
2013

WEBCAST "Application of Engineering Solutions to Solve Challenges in Pharmaceutical Processing

Pharmaceutical manufacturing of solid oral dosage forms such as tablets and capsules involves several powder handling steps, including blending, transfer, granulation, fluid bed drying, tablet compression, and encapsulation. The inability to achieve reliable powder flow during these steps can have a significant adverse effect on the manufacturing a product. Production costs can be significantly higher than anticipated due to required intervention on the part of operators, low yield, or unplanned process redesign. Powder characteristics such as particle size distribution, bulk density, cohesiveness, stickiness, and static behavior can have a significant influence on manufacturing processes for small-scale or large commercial-scale operations. Low melting or softening solids can add another handling challenge in dosage form manufacturing, especially in cases where high speed tableting is required for large-scale manufacturing. The experience from multiple projects can help alleviate or solve many of these challenges regardless of the phase of the project.

During this 60-minute interactive webcast, two industry experts will discuss challenges in powder and product handling such as flowability, stickiness, and the potential to soften or melt during the manufacture of solid dosage forms. They also will discuss the application of engineering solutions to overcome these processing challenges. Case studies will be shared to demonstrate possible solutions.

Anil Kane, Ph.D. Executive Director, Global Formulation Sciences, PDS at Patheon will discuss case studies in application of innovative solutions to solve critical powder handling issues in tableting/encapsulation.

James Prescott, Senior Consultant/Director, Jenike & Johanson, Inc., will discuss the use of bench scale tests to predict powder flow and segregation behaviors at production.

Read More

Sep
16
2013

RECORDED Webcast Application of Engineering Solutions to Solve Challenges in Pharmaceutical Process

Pharmaceutical manufacturing of solid oral dosage forms such astablets and capsules involves several powder handling steps, includingblending, transfer, granulation, fluid bed drying, tablet compression, andencapsulation. The inability to achieve reliable powder flow during these stepscan have a significant adverse effect on the manufacturing a product.Production costs can be significantly higher than anticipated due to requiredintervention on the part of operators, low yield, or unplanned processredesign. Powder characteristics such as particle size distribution, bulkdensity, cohesiveness, stickiness, and static behavior can have a significantinfluence on manufacturing processes for small-scale or large commercial-scaleoperations. Low melting or softening solids can add another handling challengein dosage form manufacturing, especially in cases where high speed tableting isrequired for large-scale manufacturing. The experience from multiple projectscan help alleviate or solve many of these challenges regardless of the phase ofthe project.

During this 60-minute interactive webcast, two industry experts will discusschallenges in powder and product handling such as flowability, stickiness, andthe potential to soften or melt during the manufacture of solid dosage forms.They also will discuss the application of engineering solutions to overcomethese processing challenges. Case studies will be shared to demonstratepossible solutions.

Speakers:

AnilKane, Ph.D., Executive Director, Global Formulation Sciences,PDS, Patheon

James Prescott, Senior Consultant/Director, Jenike& Johanson, Inc.

Register Here

Sep
25
2013

Recorded WEBCAST Application of Engineering Solutions to Solve Challenges in Pharmaceutical Process

Pharmaceutical manufacturing of solid oral dosage forms such astablets and capsules involves several powder handling steps, includingblending, transfer, granulation, fluid bed drying, tablet compression, andencapsulation. The inability to achieve reliable powder flow during these stepscan have a significant adverse effect on the manufacturing a product.Production costs can be significantly higher than anticipated due to requiredintervention on the part of operators, low yield, or unplanned processredesign. Powder characteristics such as particle size distribution, bulkdensity, cohesiveness, stickiness, and static behavior can have a significantinfluence on manufacturing processes for small-scale or large commercial-scaleoperations. Low melting or softening solids can add another handling challengein dosage form manufacturing, especially in cases where high speed tableting isrequired for large-scale manufacturing. The experience from multiple projectscan help alleviate or solve many of these challenges regardless of the phase ofthe project.

During this 60-minute interactive webcast, two industry experts will discusschallenges in powder and product handling such as flowability, stickiness, andthe potential to soften or melt during the manufacture of solid dosage forms.They also will discuss the application of engineering solutions to overcomethese processing challenges. Case studies will be shared to demonstratepossible solutions.

Speakers:

AnilKane, Ph.D., Executive Director, Global Formulation Sciences,PDS, Patheon

James Prescott, Senior Consultant/Director, Jenike& Johanson, Inc.

Read More

Sep
25
2013

Recorded WEBCAST Application of Engineering Solutions to Solve Challenges in Pharmaceutical Process

RecordedWebcast: Applicationof Engineering Solutions to Solve Challenges in Pharmaceutical Processing: CaseStudies from Development to Production Scale

 

Pharmaceutical manufacturing of solid oral dosage forms such astablets and capsules involves several powder handling steps, includingblending, transfer, granulation, fluid bed drying, tablet compression, andencapsulation. The inability to achieve reliable powder flow during these stepscan have a significant adverse effect on the manufacturing a product.Production costs can be significantly higher than anticipated due to requiredintervention on the part of operators, low yield, or unplanned processredesign. Powder characteristics such as particle size distribution, bulkdensity, cohesiveness, stickiness, and static behavior can have a significantinfluence on manufacturing processes for small-scale or large commercial-scaleoperations. Low melting or softening solids can add another handling challengein dosage form manufacturing, especially in cases where high speed tableting isrequired for large-scale manufacturing. The experience from multiple projectscan help alleviate or solve many of these challenges regardless of the phase ofthe project.

During this 60-minute interactive webcast, two industry experts will discusschallenges in powder and product handling such as flowability, stickiness, andthe potential to soften or melt during the manufacture of solid dosage forms.They also will discuss the application of engineering solutions to overcomethese processing challenges. Case studies will be shared to demonstratepossible solutions.

Speakers:

AnilKane, Ph.D., Executive Director, Global Formulation Sciences,PDS, Patheon

James Prescott, Senior Consultant/Director, Jenike& Johanson, Inc.

Oct
08
2013

Recorded WEBCAST Application of Engineering Solutions to Solve Challenges in Pharmaceutical Process

Pharmaceutical manufacturing of solid oral dosage forms such as tablets and capsules involves several powder handling steps, including blending, transfer, granulation, fluid bed drying, tablet compression, and encapsulation. The inability to achieve reliable powder flow during these steps can have a significant adverse effect on the manufacturing a product. Production costs can be significantly higher than anticipated due to required intervention on the part of operators, low yield, or unplanned process redesign. Powder characteristics such as particle size distribution, bulk density, cohesiveness, stickiness, and static behavior can have a significant influence on manufacturing processes for small-scale or large commercial-scale operations. Low melting or softening solids can add another handling challenge in dosage form manufacturing, especially in cases where high speed tableting is required for large-scale manufacturing. The experience from multiple projects can help alleviate or solve many of these challenges regardless of the phase of the project. 

During this 60-minute interactive webcast, two industry experts will discuss challenges in powder and product handling such as flowability, stickiness, and the potential to soften or melt during the manufacture of solid dosage forms. They also will discuss the application of engineering solutions to overcome these processing challenges. Case studies will be shared to demonstrate possible solutions. 

Presenters:

Anil Kane, Ph.D. 
Executive Director, 
Global Formulation Sciences, PDS 
Patheon 

James Prescott 
Senior Consultant/Director 
Jenike & Johanson, Inc.

Recorded Version 

Feb
03
2014

Recorded WEBCAST on Robustness, Reproducibility and Risk Management

Bringing a molecule to the market reliably and cost-effectively.

Recorded Webcast: Robustness, Reproducibility and Risk Management

For many CDMOs late stage development for solid and sterile pharmaceutical products is a critical phase and a huge challenge; manufacturing a product with reliable high quality requires a significant increase in financial commitment.

Robust, reliable and repeatable processes can pay dividends on the route to successful commercialisation and applying a Quality by Design (QbD) program can guarantee this success. Our webinar leaders will share insights into a proven path through scale up and technology transfer to commercialisation.

Speakers:

Romano Rivolta
, Senior Director Business Management and Technology Transfer, Patheon
Mike Dey, Managing Director, Claidmhor Pharma

Feb
04
2014

RECORDED Webcast on Robustness, Reproducibility and Risk Management

Bringing a molecule to the market reliably and cost-effectively.

For many CDMOs late stage development for solid and sterile pharmaceutical products is a critical phase and a huge challenge; manufacturing a product with reliable high quality requires a significant increase in financial commitment.

Robust, reliable and repeatable processes can pay dividends on the route to successful commercialisation and applying a Quality by Design (QbD) program can guarantee this success. Our webinar leaders will share insights into a proven path through scale up and technology transfer to commercialisation.

Read More

Feb
04
2014

表題:頑健性、再現性およびリスクマネジメント ~商品化成功への道~

信頼性が高く、コスト効率良く医薬品を上市する医薬品開発製造委託機関)の多くにとって固形及び無菌医薬品の

開発後期は非常に重要な段階であり、また大きな課題があります。信頼できる高品質な製品を製造するには、より多くの資金投入が必要となります。

頑健性があり、信頼性が高く、再現可能なプロセスは、商品化成功に向けた過程で有用であり、QbDプログラムの適用によってこの成功が保証されます。当社のオンラインセミナーでは、スケールアップおよび技術移管から商品化までの実証されたプロセスについてお話します。

<終了後オンデマンドセミナーとして配信>

 

詳細はこちら

Feb
14
2014

Recorded WEBCAST on Robustness, Reproducibility and Risk Management

Robust, reliable and repeatable processes can pay dividends on the route to successful commercialisation and applying a Quality by Design (QbD) program can guarantee this success. Our webinar leaders will share insights into a proven path through scale up and technology transfer to commercialisation.

Learn more about:

  • Successful scale up from Phase III clinical trials to manufacturing
  • Selecting the optimal metrics to accelerate the scale up process
  • Completing a tech transfer effectively without interruptions
  • Mitigating regulatory, supplier and natural disaster risks by using a back-up manufacturing site
  • Building robustness and efficiency by applying QbD to process development

Speakers:

RomanoRivolta, Senior Director Business Management and Technology Transfer (Patheon)

MikeDey, Managing Director (ClaidmhorPharma)

Register Here

Apr
08
2014

Recorded WEBCAST on Challenges in the Development of Active Drug-layered Formulations

Active drug layering provides tremendous opportunities in the development of immediate-release dosage forms of a single drug entity or fixed-dose combination drugs. The technique also has been widely used to develop modified-release dosage forms as a monolithic system or as multiparticulates with a possibility of targeting the release to a specific region of the gastrointestinal tract. The development of an active drug-layered formulation can pose challenges based on properties of the API, dose, processing parameters, target release profiles required, and other factors. The webcast discusses applications of this technique, development considerations, manufacturing and analytical challenges, and case studies.

Speakers: Don Barbieri, Terri Williamson, Robert Diehl

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Apr
08
2014

WEBCAST Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms

Active drug layering provides tremendous opportunities in the development of immediate-release dosage forms of a single drug entity or fixed-dose combination drugs. The technique also has been widely used to develop modified-release dosage forms as a monolithic system or as multiparticulates with a possibility of targeting the release to a specific region of the gastrointestinal tract. The development of an active drug-layered formulation can pose challenges based on properties of the API, dose, processing parameters, target release profiles required, and other factors. The webcast discusses applications of this technique, development considerations, manufacturing and analytical challenges, and case studies.

Speakers: 

Donald Barbieri,
Associate Director Formulation and Process Development 
Patheon 

Tracy Williamson. Pharmaceutical Development Services 
Patheon 

Robert Diehl, MS, MBA, Analytical Development/Pharmaceutical Development Services 
Patheon 

Read More

Apr
10
2014

RECORDED Webcast on Overcoming Challenges in the Development of Active Drug-Layered Formulations

Active drug layering provides tremendous opportunities in the development of immediate-release dosage forms of a single drug entity or fixed-dose combination drugs. The technique also has been widely used to develop modified-release dosage forms as a monolithic system or as multiparticulates with a possibility of targeting the release to a specific region of the gastrointestinal tract. The development of an active drug-layered formulation can pose challenges based on properties of the API, dose, processing parameters, target release profiles required, and other factors. The webcast discusses applications of this technique, development considerations, manufacturing and analytical challenges, and case studies. 

Speakers: 

Donald Barbieri
 
Associate Director 
Formulation and Process Development 
Patheon 

Tracy Williamson 
Pharmaceutical Development Services 
Patheon 

Robert Diehl, MS, MBA 
Analytical Development/Pharmaceutical Development Services 
Patheon 

 

Read More


May
21
2014

WEBCAST "Life Cycle Management Opportunities in Softgel Technologies

Drug delivery technology based on the softgels is widely accepted as preferred dosage form in the consumer healthcare, and is recognized as an interesting life cycle opportunity for pharmaceutical products. One such opportunity is the development of dosage forms for specific populations, like pediatrics, although this area of formulation development is relatively uncovered and novel. The European Medicines Agency has stated: “The joint goal for industry, regulators, practitioners and patients is to encourage pediatric drug development in order to create a situation where substantially more children have access to safe and effective medication…”.

The webinar will present the benefits and limitations offered by Chewels™ as a pediatric dosage form through an actual case study of an approved generic application of a chewable softgel. Formulation options, manufacturing, and regulatory aspects will be discussed, with relevant subjects like pediatric guidelines, cross linking of gelatin and regulatory perception, bioequivalence approach, and general feedback on the dosage form by health authorities during the registration process.

Speakers:

Kaspar van den Dries, Senior Director Formulation Sciences Solid Dose and Softgels, Patheon

Katja van Eijndhoven, MTOPRA, Regulatory Affairs Manager, Banner Life Sciences

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May
23
2014

Recorded WEBCAST on Life Cycle Management Opportunities in Softgel Technologies

Drug delivery technology based on the softgels is widely accepted as preferred dosage form in the consumer healthcare, and is recognized as an interesting life cycle opportunity for pharmaceutical products. One such opportunity is the development of dosage forms for specific populations, like pediatrics, although this area of formulation development is relatively uncovered and novel. The European Medicines Agency has stated: “The joint goal for industry, regulators, practitioners and patients is to encourage pediatric drug development in order to create a situation where substantially more children have access to safe and effective medication…”.

The webinar will present the benefits and limitations offered by Chewels™ as a pediatric dosage form through an actual case study of an approved generic application of a chewable softgel. Formulation options, manufacturing, and regulatory aspects will be discussed, with relevant subjects like pediatric guidelines, cross linking of gelatin and regulatory perception, bioequivalence approach, and general feedback on the dosage form by health authorities during the registration process.

Speakers:

Kaspar van den Dries - Senior Director Formulation Sciences Solid Dose and Softgels, Patheon

Katja van Eijndhoven - Regulatory Affairs Manager, Banner Life Sciences

Register Here

May
29
2014

WEBCAST on Advancing Your Injectable Into FIM By Implementing Robust Formulation Strategies

As the healthcare industry moves away from clinical visits, notably those for injected therapies, pharmaceutical companies need to find new ways to capitalize on the opportunities in the evolving marketplace.  Whether you are developing a new drug or exploring lifecycle management opportunities, formulation expertise and latest technologies will enable you to launch a high-quality sterile product into the market place.

Presenter: Tony Pidgeon, Senior Manager, Global Science and Technology, Patheon

Read more

Jun
11
2014

Recorded WEBCAST on Lyophilization Cycle Design and Scale Up

Recorded Webcast: Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles

Lyophilization or freeze drying is a well established process in manufacturing of sterile injectable products. The Lyocycle involves freezing, primary drying and secondary drying. Development of a lyo cycle and understanding of heat and mass transfer under different load conditions is critical in development of a robust lyophilization process.

The webinar will focus on establishing a lyophilization scale- up model that is aimed to demonstrate the full scalability between lab and production lyo in order to allow to perform the development or optimisation of a freeze-drying cycle in the pilot freeze dryer with significant cost savings.

Speakers:

Enrico Corona, Formulation and Production Manager, Patheon
Ronald Pate, Lyophilization Scientist, Customer Project Support, Patheon

Jun
11
2014

WEBCAST on "Lyophilization Cycle Design and Scale Up

Lyophilization or freeze drying is a well established process in manufacturing of sterile injectable products. The Lyocycle involves freezing, primary drying and secondary drying. Development of a lyo cycle and understanding of heat and mass transfer under different load conditions is critical in development of a robust lyophilization process.

The webinar will focus on establishing a lyophilization scale- up model that is aimed to demonstrate the full scalability between lab and production lyo in order to allow to perform the development or optimisation of a freeze-drying cycle in the pilot freeze dryer with significant cost savings.

Speakers:

Enrico Corona - Formulation and Production Manager, Patheon

Ronald Pate - Lyophilization Scientist, Customer Project Support, Patheon

Register Here

Jun
24
2014

WEBCAST on QbD Strategies for Successful Drug Product Formulation

Quality-by-Design (QbD) is a strategic approach that helps companies achieve higher process understanding, enhanced control, better product quality, increased data for continuous improvement and potential for reduced FDA approval times. Implementing a robust QbD strategy allows Pharma, Biotech and contract service providers to build leaner processes and achieve the ultimate goal for successful product development and manufacturing.

This live webinar examines the opportunities in QbD projects, including the hurdles in implementing QbD from a contractors’ perspective. Join us to discover how to define a successful strategy and execute a systematic scientific plan to overcome challenges and meet regulatory requirements.

Speakers:

Anil Kane Ph.D. MBA 
Global Head of Formulations, Patheon

Steve Closs 
Director, Global Technical Affairs, Patheon

Read More

Jun
24
2014

Recorded WEBCAST on QbD Strategies for Successful Drug Product Formulation

Recorded WebcastQbD Strategies for Successful Drug Product Formulation

Quality-by-Design (QbD) is a strategic approach that helps companies achieve higher process understanding, enhanced control, better product quality, increased data for continuous improvement and potential for reduced FDA approval times. Implementing a robust QbD strategy allows Pharma, Biotech and contract service providers to build leaner processes and achieve the ultimate goal for successful product development and manufacturing.

This live webinar examines the opportunities in QbD projects, including the hurdles in implementing QbD from a contractors’ perspective. Join us to discover how to define a successful strategy and execute a systematic scientific plan to overcome challenges and meet regulatory requirements.

Speakers

Anil Kane Ph.D. MBA, Global Head of Formulations, Patheon
Steve Closs, Director, Global Technical Affairs, Patheon

Jul
17
2014

Recorded WEBCAST - Analytical Challenges & Case Studies in Method Dev. for Fixed-Dose Combinations

Recorded Webcast: Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations

Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug’s efficacy and improve patient compliance. Pharmaceutical companies are turning to these fixed-dose combinations to maximize product value and expand a product’s lifecycle. 

In this webcast, experts will discuss challenges and solutions for the development of analytical methods associated with fixed-dose combinations. Case studies will demonstrate the complexities involved with analyzing these dosage forms. 

Speakers:

Gordon Marr, PDS Analytical Development
Maureen McLaughlin, Analytical Chemist
Yue Chen, PDS Analytical Development

Jul
17
2014

WEBCAST on Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations

Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug’s efficacy and improve patient compliance. Pharmaceutical companies are turning to these fixed-dose combinations to maximize product value and expand a product’s lifecycle.

In this webcast, experts will discuss challenges and solutions for the development of analytical methods associated with fixed-dose combinations. Case studies will demonstrate the complexities involved with analyzing these dosage forms.

Speakers:

Gordon Marr, PDS Analytical Development
Maureen McLaughlin, Senior Manager
Yue Chen, PDS Analytical Development

Read More

Sep
16
2014

WEBCAST on Applying single-use technologies in Biopharmaceuticals to achieve Supply Chain Excellence

Single-use technologies have revolutionized manufacturing operations in the biopharmaceutical industry, for both drug substance and drug product. While they are now commonly used for production of clinical trial material, new flexible facility design incorporating single-use technologies can also enable more efficient commercial manufacturing of monoclonal antibodies and other biopharmaceutical products. 

This live session will feature case studies showcasing the application of single-use technologies to drug substance and drug product manufacture.

Webinar highlights:

• Capacity increases and how they were realised due to the introduction of single-use technologies
• Extractables and leachables strategies
• Product development strategy and the use of single-use technologies
• Flexible manufacturing facilities and how to reduce footprint
• Technological possibilities for increased supply of commercial quantities of biopharmaceuticals

Speakers: 

Tony Pidgeon, Director, Applied Technology Finished Dose, Patheon
John McGuire, Director, Applied Technology, Biologics API – EMEA/APac, Patheon

Time (Check Local Time):
14:00 BST (British Summer Time)
15:00 CEST (Central European Summer Time)
09:00 EDT (Eastern Daylight Time)
06:00 PDT (Pacific Daylight Time) 

Register here to secure your place!

Sep
16
2014

Recorded WEBCAST on Applying single-use technologies in Biopharmaceuticals

Recorded Webcast: Applying single-use technologies in Biopharmaceuticals to achieve Supply Chain Excellence

Single-use technologies have revolutionized manufacturing operations in the biopharmaceutical industry, for both drug substance and drug product. While they are now commonly used for production of clinical trial material, new flexible facility design incorporating single-use technologies can also enable more efficient commercial manufacturing of monoclonal antibodies and other biopharmaceutical products. 

This live session will feature case studies showcasing the application of single-use technologies to drug substance and drug product manufacture.

Webinar highlights:

• Capacity increases and how they were realised due to the introduction of single-use technologies
• Extractables and leachables strategies
• Product development strategy and the use of single-use technologies
• Flexible manufacturing facilities and how to reduce footprint
• Technological possibilities for increased supply of commercial quantities of biopharmaceuticals

Speakers: 

Tony Pidgeon, Director, Applied Technology Finished Dose, Patheon
John McGuire, Director, Applied Technology, Biologics API – EMEA/APac, Patheon

Sep
17
2014

Recorded WEBCAST on API Characterization for a Speedy and Successful Formulation Strategy

Recorded Webcast: API Characterization for a Speedy and Successful Formulation Strategy

The physicochemical properties of the API in a solid state are extremely important as they affect the choice and design of formulation as well as the performance of the dosage form. A robust solid-state characterization of the API at an early stage helps drug developers better understand the properties of the API and the effect these characteristics have on the drug behavior, especially on uniform distribution, solubility, stability, and its in-vitro dissolution and bioavailability. This information impacts formulation and development decisions. In this webinar, experts examine key API properties and their impact on formulation design and development decisions.

In this webinar, experts examine key API properties and their impact on formulation design and development decisions.

Speakers: 

Anil Kane Ph.D. MBA, Executive Director, Global Formulation Sciences, PDS
Friedrich Brandl, Quality Manager, DSM Pharma Chemicals, Regensburg (ResCom®)

Sep
18
2014

WEBCAST on API Characterization for a Speedy and Successful Formulation Strategy

The physicochemical properties of the API in a solid state are extremely important as they affect the choice and design of formulation as well as the performance of the dosage form. A robust solid-state characterization of the API at an early stage helps drug developers better understand the properties of the API and the effect these characteristics have on the drug behavior, especially on uniform distribution, solubility, stability, and its in-vitro dissolution and bioavailability. This information impacts formulation and development decisions. In this webinar, experts examine key API properties and their impact on formulation design and development decisions.

Key Learning Objectives:

• Understand critical API solid-state characterization parameters
• Review the impact on formulation design and addressing drug product performance challenges
• Improve speed and flexibility in early phase development

Speakers: 

Anil Kane Ph.D. MBA, Executive Director, Global Formulation Sciences, PDS
Friedrich Brandl, Quality Manager, DSM Pharma Chemicals, Regensburg (ResCom®)

Read More

Oct
15
2014

WEBCAST on Systematic and Efficient Methods for a Speedy Clinical Product Development

This webinar will present strategies for fast, efficient, and effective analytical method development for preclinical and early clinical development programs.  In most cases, development and qualification of analytical methods is rate-limiting for drug candidates moving rapidly from discovery to first-in-man studies. The key to success is to balance the tasks of performing sufficient method development to ensure safety in the clinical programs; building a base of scientific knowledge to support development; and meeting development timelines with available resources. Presentations will include discussions and case studies for:

•          Rapid chromatographic method development for preclinical drug programs
•          Analytical method problem solving for early clinical development formulations

Key Learning Objectives: 

•          Understand how to rapidly develop analytical methods for preclinical drug programs.
•          Identify and solve problems with analytical methods for early clinical formulations.
•          Understand trade-offs between available scientific knowledge and project deadlines from an analytical method development perspective.

Speakers: 

Andrew Leason, Analytical Development Scientist, Patheon
Richard R. Goodin, Senior Analytical Chemist, Early Development, Pharmaceutical Development Services, Patheon

Read More

Nov
15
2014

Recorded WEBCAST on "Increasing your chances for success in First-In-Man studies"

The path to First in Man studies is a long road with many choices to make based on little to no information. In many cases, knowing the right path to take is dependent upon the signs read along the way and understanding which signs contain relevant information. Whether you are faced with bioavailability issues, financial constraints, or pressure to meet accelerated deadlines, having a well-designed development plan for your molecule can make the difference between success and failure. This webcast will provide you with insight into how to find the right signs and understand them to help you speed along the path to achieve the best outcomes. You will hear a detailed case study about the development of an insoluble compound that otherwise never would have made it to First in Man and lessons learned from that experience. These presentations and interactive Q&A sessions will provide you with insight into how to speed your molecule to First in Man studies with an optimal formulation strategy.

“Successful Dosage Form Development for First in Man”

JasonVaughn, Ph.D., Director of Scientific Affairs, Patheon, Inc

 

“A Case Study on Getting an Insoluble Compound into Man”

JimWright, Ph.D., Chief Scientific Officer at BIND Biosciences

 

Register here

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