Prashant Varma Email and Phone Number

-Part of Scale-up group before tech transfer to pilot plant/GMP manufacture-Lead and assist in non-GMP harvesting of cell culture by centrifugation and depth filtration, chromatography for purification of proteins, and Tangential Flow Filtration (TFF) and final filtration for manufacturing of Bulk Drug Substance (BDS)-Perform intermediate hold stability studies-Perform lab-scale harvest, chromatography using Akta Avant system (Unicorn software), and TFF-Packing of bench-scale and intermediate scale resin columns-Evaluating new technologies like Single Pass TFF, in-line concentration measurements during TFF-Evaluation of technologies like spray drying of biopharmaceuticals, prediction of viscosity at higher concentrations etc-Authoring Drug Substance section of BLA

-Overseeing tech-transfer of biopharmaceutical drug product manufacturing in the New Product Introduction group- Providing technical expertise while filling drug product in syringes and vials in a GMP environment - Helping in troubleshooting and risk-assessing filling needle clogging issues for high concentration drug products - Exposure to operations of automated visual inspection and packaging of pre-filled syringes into Safety Device, and Auto-injectors

- Formulation development of protein molecules and analysis for early to late stage development. Experience with HPLC, UV & fluorescence spectrophotometry, SDS-PAGE, Capillary Gel Electrophoresis (Caliper), rheometry, Circular Dichroism, cap-DSC, DLS, and theoretical knowledge of most of the biophysical techniques. - Experienced in small-scale filling and sealing of vials containing formulations for stability studies, shake and freeze-thaw studies, shelf-life profile management, compatibility studies, and in writing protocols and reports. - Lyophilization of protein formulations- Preliminary knowledge of topical drug delivery- Contributed to the formulation section of IMPD for a monoclonal antibody sub-unit for Phase IIa- Contributing to the P.2. section of a BLA for a monoclonal antibody

Formulation development of protein molecules and analysis for early to late stage development. Experience with HPLC, UV & fluorescence spectrophotometry, Circular Dichroism, SDS-PAGE, rheometry, theoretical knowledge of most of the biophysical techniques. Experienced in small-scale filling and sealing of vials containing formulations for stability studies, shake and freeze-thaw studies, shelf-life profile management, and in writing protocols and reports. Oversaw pilot-plant scale filling of a high-concentration of monoclonal antibody in glass and plastic syringes, and glass vials, and managed stability studies for 2 years to decide the right formulation and container. Presented the results in poster format in internal, and external conference (2012 Workshop on Protein aggregation and immunogenicity, Breckenridge, Colorado).

Research Associate in Preformulation and Formulation Development Department, New Chemical Entity Research (small molecules)

Research Associate in Formulation Development Department (small molecules). Modifying previous formulations to improve the stability or other physical characteristics of oral solid/liquid formulations.