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 SHORT COURSE 11: MATERIALS IN CONTACT WITH BIOLOGICS: UNDERSTANDING RISK TO QUALITY AND SAFETY


Materials that contact biologics during manufacturing, storage and final packaging can pose risks to biopharmaceutical quality. This in-depth course reviews the regulatory requirements, types of materials used and material chemistry, and then examines the strategies for prediction and risk assessment of potential threats to quality and safety of biologics drug products. The course reviews development of a successful analytical strategy for single-use components, container closure components and risk posed by leachables.

Topic to be covered:
The Types of Materials Used in the Manufacture and Storage of Biologics

  • Manufacturing Components
  • Container Closure Components

The Regulatory Landscape

  • CBER, ICH, USP, PQRI

Understanding Material Chemistry

  • Plastic, Rubber, Glass, Metal

Strategy for Assessing Suitability of Components for Intended Use
Manufacturing Components: Single-Use and Disposables

  • Conditions of Use
  • System Compatibility
  • Critical Components
  • Critical Assessments

Container Closure Components/ Primary Systems

  • Conditions of Use
  • System Compatibility
  • Critical Components
  • Critical assessments

Interaction of Biologics with Product Contact Materials

  • Yeild
  • Leachables
  • Protein Stability

Closing Remarks and Future Perspective: Where Are We Now and Where Are We Going

Instructors:   

Diane Paskiet, Ph.D., Director of Scientific Affairs, West Pharmaceutical 

 Jeffrey Carter, Ph.D., Strategic Projects Leader, GE Healthcare 

 

Speaker Biographies: 

Diane PaskietDiane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceuticals

Dr. Paskiet has over twenty years of experience in polymer analysis relating to product failures, deformualtion and migration studies.  She has served as a project advisor in support of qualification studies associated with container closure systems for IND and NDA filings. Her current responsibilities include coordination of studies for technical support and R&D. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories.

JeffreyCarterJeffrey Carter, Ph.D., Strategic Projects Leader, GE Healthcare

Dr. Carter has been a supplier to the bio/pharmaceutical manufacturing industry for the past twenty years, and he has been with GE Healthcare Life Sciences since 2005, serving in R&D and Marketing capacities.  Before this, he served in R&D and product management capacities at Millipore Corp.  In an R&D capacity at GE, he managed a group responsible for product development related to filtration and single-use products intended for use in biopharmaceutical manufacturing. He has also served in product management and in acquisition integration.  Recently, he has led efforts within GE to assure that raw materials, suppliers, and the supply chain for GE single-use products are at an appropriately high quality standard.  He has been active in organizations such as the Parenteral Drug Association and ASTM E55, and is a board member of the BioProcess Systems Alliance. His present role as Regulatory Strategy Leader is to serve as a voice for evolving regulatory and de facto expectations related to the global implementation of single-use manufacturing.  Dr. Carter holds a PhD degree from Penn State University in molecular microbiology.

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