Successful Transfer of Biotherapeutic Characterization Methods 
Mihir Thakar
Product Manager, Phenomenex
Tuesday, August 8, 2023
10:00 AM - 11:00 AM (PT)
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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