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SC10 - Bioprocess Development: Considerations for the Quality and Safety of Materials in Contact with Biologics

 

  • 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: 

 DianePaskietDiane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceutical Services  

Ms. Paskiet has over twenty years of experiencein 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 supportand R&D.Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories.

 

Jeffrey Carter, Ph.D., Regulatory Strategy 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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