Analytical method transfers are commonplace in the CDMO industry and may occur during the lifecycle of a project as a sponsor moves from an early stage clinical service provider to a CDMO that can support late phase and/or commercial production. Performing an analytical method transfer instead of revalidation activities may save time and money for the overall project. However, regulatory guidance is vague on the requirements of what is needed for a successful analytical method transfer. This webinar will provide an overview of the analytical method transfer process. Topics discussed will include the requirements for an analytical method transfer, a risk analysis framework that can be applied across diverse methodologies, the differences between a transfer and validation activities, and key statistical approaches that can be leveraged for a successful analytical method transfer.
Chris Berger, Sr. Director QC, Avid Bioservices, Inc.
Chris Berger joined Avid Bioservices in 2015 and is responsible for analytical method development and characterization activities within the analytical development space and raw material release and qualification, in-process analysis, lot release and stability analysis, as well as method transfer and validation within the quality control environment. Mr. Berger brings over 15 years of experience in biologics analytical method development and quality control to the Avid team. Mr. Berger has extensive experience in the development, validation, and transfer of analytical methods used for both in-process control and lot release testing. Mr. Berger’s experience has covered working with large complex molecules greater than 900 kDa to smaller enzymes, as well as traditional monoclonal antibodies. He has had a hand in developing and validating numerous analytical methods for determination of concentration, purity, and impurities in diverse and unique manufacturing processes. In addition to the development and validation of analytical methods, Mr. Berger is well versed in statistical quality control for ongoing monitoring and trending of both process and analytical performance.
Who Should Attend?
Professionals in the life sciences industry who participate in analytical method transfer activities (RAs, scientists, and lab managers).
What You Will Learn
After this webinar, participants will:
- Understand regulatory guidance around method transfer activities
- Understand experimental design approaches around method transfers
- Understand and leverage a risk-based analysis for determining transfer criteria
- Develop a baseline understanding of key statistical approaches for method transfer
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focusing on biologics derived from cell culture systems. A globally compliant partner of the biotechnology and biopharmaceutical industries, Avid offers a comprehensive range of process and analytical development and high-quality cGMP clinical and commercial manufacturing services.