Extractables and Leachables - Biopharma Polymeric Devices

Why Should You Attend:

As single-use disposable polymeric products have gained rapid acceptance by biopharmaceutical manufacturer worldwide, there are growing regulatory and industry concerns over leachables and extractables from these polymeric products.

This webinar will review current standards and regulatory issues and discuss industry trends and developments. It will review the latest industry standards and regulatory developments for examining extractables / leachables in biopharm development and manufacturing processes. It will also examine ‘how to’ make determination and which methodology, e.g., modeling, profiling and actual testing, is appropriate for the application.

Learning Objectives:

• Be able to identify process applications where leachables testing vs. modeling is acceptable.
• Understand the concepts of extractables and leachables testing / modeling to assist in writing change control documentation and meet regulatory requirements.
• Review various analytical techniques to separate, determine, quantitate (NVR) and / or qualify (ID) using RP-HPLC, GC-MS/MS, and FTIR.
• Determine which processes and polymeric products would need testing.

Areas Covered in the Webinar:

• Definition of polymeric extractables / leachables in biopharm process.
• Testing and detection techniques and technologies.
• How to determine where, when and what testing needs be done.
• Discuss the various modeling, profiling and actual testing methods.
• What are the current industry and regulatory expectation and trends for extractable /leachable analysis?
• Examine the process parameters and formulation that affect these testing studies, dosage, toxicity, surface areas, time, temperature, etc.

Who Will Benefit:

• Process development engineers and scientists
• Pilot-plant staff
• Production management and operations
• Validation and QA/QC
• RA personnel

Instructor Profile:

With over twenty years’ experience in the pharmaceutical and life science industries, Mark Trotter has a broad range of work experience, from pharmacologic chemistry research project leader to marketing management in the laboratory and process equipment industries. This extensive background in the biopharmaceutical sciences is coupled with an in-depth regulatory knowledge that supports his expertise in these areas of process validation and qualification.

He has specialized training and work experiences in filter membrane technologies, including sterilizing, prefiltration, chromatography as well as single-use disposables technologies. Upstream fermentation to downstream applications, including separations, clarification and purifications processes technologies, are areas of subject matter expertise he brings to the training, technology transfer and consulting services. He completed his post-graduate studies at Long Island University, C.W. Post College, earning his MS in Medical Microbiology and continuing on for his MBA in Finance.

Mr. Trotter has published numerous technical articles, book chapters and has contributed expert editorial comment on these subjects. He is a member of PDA (Parenteral Drug Association), ASM (American Society of Microbiology) International Society for Pharmaceutical Engineering, (ISPE.), and the American Society of Quality, (ASQ), serving on ASTM E55 Biopharma Group and the USP Filtration Expert Panel.

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