Formulation Strategies: Moving IV to SQ & Vial to PFS
The biopharma industry continues to look for ways to improve patient compliance through the transition of intravenous (IV) to subcutaneous (SQ) administration and/or vial to pre-filled syringe (PFS) presentation. Both approaches are valuable alternatives for the increasing number of patients facing chronic illnesses such as rheumatoid arthritis and multiple sclerosis, and companies are also exploring these approaches for other indications, such as oncology. In this webinar, experts will discuss the formulation development challenges, considerations, and potential solutions associated with IV to SQ transitions, as well as vial to PFS, to ensure the product’s safety and efficacy.
Paresh Vadgama Principal Scientist, Biologics Formulation and Drug Product Development Catalent Biologics
Paresh Vadgama has over 14 years of experience in the Biological Drug Product Development. He has handled a wide spectrum of therapeutic proteins ranging from small peptides, insulin/insulin analogues, to monoclonal antibodies as well as advanced modalities such as conjugated proteins, fusion proteins, bispecific antibodies, and vaccines etc.
In his current role as Principal Scientist, Biologics Formulation & Drug Product Development at Catalent, Switzerland, he is leading cross-functional efforts in the areas of Formulation, Process, Primary Packaging Development, and Tech-transfer practices across the US and EU biologics sites.
Prior to joining Catalent, he has held various positions of increasing responsibilities in R&D department of multiple biotech organizations based in Switzerland, India, and Malaysia, such as Biocon, Intas, Lupin, Glenmark and AC Immune. His career has been focused onto early- to late-stage CMC development of liquid & lyophilized dosage forms in vials, PFS and cartridges; primary & secondary packaging development, fill-finish process tech-transfer, overseeing clinical supply and the use of Quality by Design (QbD) concepts in process design. He has filed 5 formulation patents and have authored several DP sections of regulatory dossiers for US, EU, Japan & India markets.
His research interests include areas of high concentration protein formulation development & their process tech-transfer, CFD-based fill-finish model development, personalized medicine, and continuous drug product manufacturing.
He holds a master’s degree in Pharmaceutical Sciences with specialization in Drug Delivery from the prestigious Institute of Chemical Technology (formerly, UDCT), India.
Date: Wednesday, February 16, 2022 Time: 9am ET / 6am PT / 3pm CET Duration: 1 Hour