Learn more about our large scale manufacturing services and capabilities.
CHO/HEK cell line development and optimization for high productivity and robust performance.
Fed-batch and perfusion processes across multiple scales with 24/7 process monitoring and control.
Multistep chromatography, filtration and UF/DF delivering high-purity drug substance.
Aseptic fill-finish support through partners and/or internal drug product capabilities.
Transition from pilot → commercial maintaining key parameters (mixing, shear, oxygen transfer).
Stainless steel at 500 L to 230,000 L scale; multiple trains for campaign flexibility.
High-capacity chromatography skids, virus clearance steps (for mammalian), large-scale UF/DF systems (>10 m²).
Stage-wise process validation (PPQ), cleaning validation, environmental monitoring, lifecycle approach per FDA & EMA guidelines.
Commercial packaging, serialization, regulatory labeling, controlled cold chain distribution globally.
Complete PPQ documentation and lifecycle validation data
Commercial manufacturing documentation with full traceability
CoAs with comprehensive quality testing for commercial release
Real-time and accelerated stability studies supporting shelf life
Complete support for BLA/NDA/MAA submissions and updates
Shilpa Biologicals develops and manufactures recombinant proteins using microbial expression platforms — E. coli and yeast — at its Dharwad, Karnataka campus, with two 1,000-litre stainless-steel fermentation trains plus 200-litre and 20-litre vessels. Programmes include recombinant insulin for diabetes care, fusion proteins and peptide biologics, supported by integrated downstream purification, formulation and fill-finish.
Capability | Specification |
|---|---|
| Expression platforms | Escherichia coli, Saccharomyces yeast |
| Fermentation | Two independent trains — stainless-steel fermenters 1,000 L × 2, plus 200 L and 20 L |
| Development scope | Metabolic pathway engineering, high-density fermentation, multi-parallel fermentation screening |
| Downstream | Chromatography up to 2,000 L/hour, conventional and continuous chromatography, tangential flow filtration, refolding process development |
| Characterisation | High-throughput protein characterisation, primary and higher-order structure, potency bioassays |
| Fill-finish | Three suites — vials, pre-filled syringes, RTU and RTS formats |
| Site | Shilpa Biologicals, Belur Industrial Area, Dharwad, Karnataka |
Shilpa Biologicals is developing recombinant insulin products addressing the global need for affordable diabetes care. The programme draws on the group's recombinant protein expression, fermentation, purification, formulation development and analytical characterisation capability, and is designed to meet international quality and regulatory standards.
Diabetes affects over half a billion people globally, and insulin access remains constrained by cost in much of the world. Scalable, quality-compliant recombinant insulin manufacture is one of the highest-leverage contributions a manufacturer can make to global health economics — and aligns directly with Shilpa Medicare's stated purpose.
Shilpa Biologicals' microbial and mammalian platforms support fusion protein development — including Fc-fusion and albumin-fusion constructs where the group's recombinant albumin capability provides a distinctive advantage — and peptide biologics bridging the peptide chemistry capability at Raichur with biologics manufacture at Dharwad.
Development-scale microbial manufacturing for early-phase programs
End-to-end microbial fermentation and purification services
Aseptic processing and packaging for your drug product needs
Discover our integrated biologics development platform
