Mysore Ramprasad | Executive Director Analytical and Formulation Development, DP Manufacturing
Ambrx Biopharma

Mysore Ramprasad, Executive Director Analytical and Formulation Development, DP Manufacturing, Ambrx Biopharma

Dr. Ramprasad is currently Executive Director of Analytical & Formulation Development at Ambrx and is responsible for all early and late-stage CMC related internal and external analytical method development, validation, CQA and product quality oversight, batch release and stability of all drug substances and drug products.  He also oversees Drug Product Manufacturing, process characterization and validation, Comparability and Compatibility studies, and is responsible for all relevant CMC sections in global regulatory filings.  Ram also leads formulation development, formulation robustness studies, and drug delivery of precision-engineered mAb, ADCs, bispecifics, and cytokines conjugated with PEG or site-specific cytotoxics. 
Ram obtained his Ph.D. in Molecular Biophysics from the Indian Institute of Science, Bangalore; conducted his post-doctoral work at UAB, and was an Asst. Prof. at UCSD Medical School.  He has over 24 years’ experience in Biologics Product Development from early stage to BLA readiness, working in high-paced biopharmaceutical industries with significant contributions to several successful IPOs and M&A [SkyePharma, CovX, Halozyme, CMC Biologics, aTyr Pharma, and Ambrx].  He has a breadth of experience in controlled-release formulation development of cytokines and growth factors using multivesicular depot liposomes, and hyaluronidase-mediated Enhanze technology for conversion from IV to SC drug delivery.  He led Biosimilar Formulation Development projects at CMC Biologics, and has published widely and presented at International conferences. He is the inventor of two novel lipoprotein receptors and has a US patent on Depot Hyaluronidase formulation for Benign Prostatic Hyperplasia (BPH) treatment.

Appearances:



Festival of Biologics Day 2 @ 11:40

High Concentration Subcutaneous Formulation Development of ARX517, first-in-class anti-PSMA ADC, for Advanced Solid Tumor therapies

  • Review of commercial ADC formulations
  • ARX517 ADC in Phase 1 clinical development background (CMC focus)
  • Next phase ARX517 SC formulation development (first in class SC ADC formulation)
last published: 31/Jan/23 09:55 GMT
last published: 31/Jan/23 09:55 GMT

back to speakers