Successful Scaling of Biotherapeutic Characterization Methods
Analytical methods are major quality control and integrity tools for biotherapeutic drug development. Transferring these methods to one or more receiving sites or scaling them during the drug development process or post-approval is a typical, yet critical activity to meet drug development timelines. Therefore, method transfer and scaling activities must be managed effectively.
Key Learning Points:
- Learn key factors of method scaling and transfer
- Understand the options and guidelines listed in the FDA guideline and USP <621>, <1224>
- Develop tips and tricks that eases the burden of scaling and transferring methods
Who Should Attend:
- Any Method development scientists or anyone involved in optimizing/modernizing methods.
Presenter: Mihir Thakar (Product Manager, Phenomenex)
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.
