Flexible Mammalian & Microbial Drug Substance Manufacturing — Development to Commercial Scale

Industry-Leading Scale:

• Microbial fermentation capacity will reach 230,000 L when fully operational
• Positioning Shilpa as one of the largest microbial biologics CDMOs in India and globally
• Scalable infrastructure from development to commercial production
• Support for multiple products and campaigns simultaneously

• Hybrid CDMO Model: Integrated mammalian + microbial capacity helps serve diverse biologics projects—from mAbs to peptides and GLP-1s—in both clinical and commercial phases
• Scalable Infrastructure: Massive microbial capacity (230,000 L) offers unmatched scale flexibility
• Strong Technical Foundations: High-end facility controls, extensive purification pipelines, and regulatory-grade equipment ensure quality and compliance

Alongside Dharwad's microbial drug substance platform, group company Shilpa Biocare Private Limited manufactures animal-free recombinant human albumin (rHA) using a proprietary yeast-based fermentation process at Kadechur–Badiyal Industrial Area, Yadgir district, Karnataka, with more than 200 KL of fermentation capacity. Produced without any human or animal-derived raw materials, Shilpa's rHA serves cell culture, vaccine, biopharmaceutical formulation, regenerative medicine and therapeutic applications. The production technology is patented in the United States and Europe.

• Cell culture and media supplementation: A defined, animal-free albumin source for mammalian cell culture — supporting cell growth, viability and productivity in monoclonal antibody, vaccine and cell therapy manufacture, without the regulatory burden of animal-derived supplements.
• Vaccine formulation: Albumin functions as a stabiliser in vaccine formulations. A recombinant source removes plasma-derived material from the vaccine supply chain entirely.
• Biopharmaceutical formulation excipient: Prevention of protein adsorption to container surfaces, stabilisation against aggregation and interfacial stress, and cryoprotection in lyophilised formulations.
• Regenerative medicine and cell therapy: Cell and gene therapy manufacturing processes face intense regulatory scrutiny of raw material provenance. Animal-component-free albumin supports that requirement directly.
• Therapeutic albumin: Shilpa Medicare is developing recombinant human albumin as a therapeutic product. CDSCO approved the global Phase 3 clinical plan in May 2026, with Phase 3 studies initiating in India and Europe in the first half of FY2027 and an EMA Investigational Medicinal Product Dossier submission planned. A United States pre-IND engagement is targeted for FY2027.