Shilpa Biologicals is a wholly owned subsidiary of Shilpa Medicare, a company which has more than 36 years of history in HPAPI for Oncology, immunosuppressants, peptides and bio polymers. Shilpa Biologicals is a fully integrated, Clone to Commercial full service CDMO, catering to the contract development and manufacturing needs of our Biotech and Biopharma customers. Our strategy is to be a valuable partner to these customers as a full-service CDMO, having development R&D, scale up facilities both for microbial and mammalian cell culture, fill-finish, clinical affairs and bio-analytical services. Most of our facilities have gained USFDA, EMEA and other regulatory approvals and have deep partnerships with companies across the world.
We specialize in development of both novel Biologics and Biosimilars, having capability to develop mAbs, ADC, Peptides, Fusion Proteins, Vaccines and other therapeutic proteins for Cell and Gene Therapy and Alternate Food. Our ability to handle both complex chemistries esp in solid phase synthesis, mammalian cell culture for mAb and ADC development and manufacturing (using single use bioreactors) and bio-catalysis using our own developed enzymes are key differentiators. The recent expansion of our Microbial fermentation capacity to 230,000 litres is able to address large capacity needs for both therapeutic and alternate proteins where cost economies become significant.
Our partnering approach is flexible to meet the development and scale up demands of small and medium biotech, to enable them to progress through Biologics development life cycle, and at the same time, support our large Biopharma customers with late-stage and commercial production of large quantities of finished products (both DS and DP).