Patheon is a global provider of development and commercial manufacturing services for solid and sterile prescription drugs, offering a wide variety of services and products. SEE AND Read More »
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.
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:
Plan now for the meeting that extends your boundaries.
Meet with Patheon!
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 there!
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.
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.
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.
Andrew Leason, Analytical Development Scientist, Patheon
Richard R. Goodin, Senior Analytical Chemist, Early Development, Pharmaceutical Development Services, Patheon
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.
Romano Rivolta, Senior Director Business Management and Technology Transfer, Patheon
Mike Dey, Managing Director, Claidmhor Pharma
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
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.
Kaspar van den Dries - Senior Director Formulation Sciences Solid Dose and Softgels, Patheon
Katja van Eijndhoven - Regulatory Affairs Manager, Banner Life Sciences
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.
Enrico Corona, Formulation and Production Manager, Patheon
Ronald Pate, Lyophilization Scientist, Customer Project Support, Patheon
Recorded Webcast: 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.
Anil Kane Ph.D. MBA, Global Head of Formulations, Patheon
Steve Closs, Director, Global Technical Affairs, Patheon
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.
Gordon Marr, PDS Analytical Development
Maureen McLaughlin, Analytical Chemist
Yue Chen, PDS Analytical Development
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.
Anil Kane Ph.D. MBA, Executive Director, Global Formulation Sciences, PDS
Friedrich Brandl, Quality Manager, DSM Pharma Chemicals, Regensburg (ResCom®)
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