Pranhitha has 35 years of experience developing recombinant proteins and viral vectors for the clinic at Immunex, Amgen, SeaGen and as an independent consultant.   

She received her PhD in Biochemistry at Brandeis, followed by postdoctoral training in molecular cell biology at MIT.  She completed a certification course in Clinical Trials and Regulatory Affairs at the University of Washington. 

Pranhitha has extensive experience. Leading cross-functional teams in antibody and gene therapy product development from gene sequence to BLA and successful launch.   Her current consulting areas include: 

• CMC strategy, regulatory filing for early, late and post commercial stages.  

• Protein and viral vector design for expression in mammalian cells 

• Assessment and development of mammalian expressions platforms (including host, recombinant cell lines, and cell banks)  

• Development of high yield cell culture process development and product quality control to meet drug product comparability.    

• Biosafety and viral clearance