Successful Scaling and Transfer of Biotherapeutic Characterization Methods

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Successful Transfer of Biotherapeutic Characterization Methods

Mihir Thakar

Product Manager, Phenomenex

Tuesday, August 8, 2023

10:00 AM - 11:00 AM (PT)

Overview:

Analytical methods are major quality control and integrity tools for biotherapeutic drug development. Transferring these methods to one or more receiving sites during the drug development process or post-approval is a typical, yet critical activity to meet drug development timelines.

Key Learning Points:

Learn key factors of method transfer, as well as modernization
Understand the options and guidelines listed in the FDA guideline and USP <621>, <1224>
Develop tips and tricks that eases the burden of ensuring robust, fit -for-purpose methods

Who Should Attend:

Any Method development scientists or anyone involved in optimizing/modernizing methods.

Speaker Bio:

Mihir holds master’s degree in biotechnology. He has over a decade of experience working with various Biopharma companies in characterization of therapeutic peptides, proteins, and Oligonucleotides.

He has been associated with Phenomenex more than 5 years, served in various functions including Business Dev. Manager- Biologics. At present, he has been working as a Global Product Manager- Biopharma segment.

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