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Meet us at 2015 Drug Delivery Partnerships Conference!

January 28-30 | Boca Raton, FL USA

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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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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

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
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

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

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

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

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

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 

 

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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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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

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.

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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

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 

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.

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.

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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

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

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

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
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
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 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
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
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
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 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

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”

 

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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.

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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
                   

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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.


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

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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.

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