Learn more about our biological drug development & 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.
Large-scale microbial production for commercial needs
Shilpa Biologicals offers clone-to-vial biologics contract development and manufacturing from one EU-GMP certified campus — cell line development, mammalian and microbial upstream processing, downstream purification, formulation, three independent fill-finish suites, analytical characterisation and regulatory support, all under one quality system.
Stage | Capability |
|---|---|
| Cell line development | CHO and HEK platform selection, transfection, clone screening and selection, stability and productivity assessment, automated GMP master and working cell bank generation and storage |
| Upstream — mammalian | Media and feed development, fed-batch and perfusion, multi-parallel bioreactor screening, scale-up through 20 L / 50 L seed → 200 L → 1,000 L → 4,000 L single-use, with design headroom to 8,000 L |
| Upstream — microbial | E. coli and yeast expression, high-density fermentation, metabolic pathway engineering, 1,000 L × 2 stainless steel plus 200 L and 20 L |
| Downstream | Capture and polishing chromatography up to 2,000 L/hour, viral clearance, tangential flow filtration, refolding, conventional and continuous chromatography, 2–8 °C controlled processing |
| Formulation | Excipient screening, aggregation and interfacial stability control, liquid and lyophilised presentations, container-closure selection |
| Fill-finish | Three independent suites — RTU combination line 40 parts/minute (vials + PFS); RTU combination line 20 parts/minute (multi-format); RTS vial line 300 parts/minute (2–100 mL) |
| Bioconjugation | 200 L single-use bioconjugation reactors; lyophilisation to 65 kg |
| Analytical & QC | Primary and higher-order structure, glycan profiling, charge variant analysis, potency bioassays, forced degradation, comparability studies, lot release; LIMS-managed, 21 CFR Part 11 compliant |
| Regulatory | CMC authoring, comparability strategy, EMA and emerging-market dossiers, agency query response |
Shilpa Biologicals' mammalian trains are built on single-use technology. For a CDMO customer this has direct consequences: no cleaning validation between programmes, materially reduced cross-contamination risk, faster changeover between campaigns, and lower barrier to running multiple client programmes in parallel without the campaign scheduling constraints of stainless-steel facilities.
More than 20 active biologics CDMO projects, with approximately one new customer added per quarter and three Phase 3 programmes underway. Named collaborations include NXI Therapeutics AG (long-term CMC development, scale-up, GMP clinical supply and commercial manufacture for an immunomodulatory programme), mAbTree Biologics (novel immuno-oncology monoclonal antibody, US FDA Orphan Drug Designation January 2026) and Orion Corporation (nivolumab biosimilar co-development and European supply).
Shilpa Biologicals develops biosimilars across oncology, immunology and ophthalmology using mammalian cell culture platforms at its EU-GMP certified Dharwad campus. The pipeline includes adalimumab, aflibercept, nivolumab, pembrolizumab, daratumumab, dupilumab, trastuzumab and two antibody-drug conjugate biosimilars. Commercial partnerships cover Europe with Orion Corporation and 30+ Latin American countries with SteinCares.
Biologics account for a growing majority of pharmaceutical value and a disproportionate share of healthcare cost. As reference products lose exclusivity, biosimilars offer the single largest available lever on the cost of advanced therapy.
The barrier is capability. A biosimilar is not a copy — it must be demonstrated highly similar to the reference product in structure, function, purity, potency and clinical performance. That requires cell line engineering, process development that reproduces a specific glycosylation and charge profile, analytical characterisation of extraordinary depth, and comparability data that satisfies the EMA or the US FDA. Shilpa Biologicals built the platform for that work: advanced mammalian cell culture, continuous bioprocessing capability, comprehensive analytical characterisation, and integrated fill-finish — all on one EU-GMP certified site.
Molecule | Therapy Area | Reference Class | Status |
|---|---|---|---|
| Adalimumab | Immunology | Anti-TNF monoclonal antibody | Development complete; launched in India |
| Aflibercept | Ophthalmology | Anti-VEGF fusion protein | Phase 1/3 clinical |
| Nivolumab | Oncology | Anti-PD-1 monoclonal antibody | Phase 1/3 clinical; Orion partnership for Europe |
| Pembrolizumab | Oncology | Anti-PD-1 monoclonal antibody | In development |
| Trastuzumab | Oncology | Anti-HER2 monoclonal antibody | In development |
| Daratumumab | Oncology / haematology | Anti-CD38 monoclonal antibody | Pre-clinical |
| Dupilumab | Immunology / dermatology | Anti-IL-4Rα monoclonal antibody | Pre-clinical |
| Trastuzumab emtansine | Oncology | Antibody-drug conjugate | In development |
| Trastuzumab deruxtecan | Oncology | Antibody-drug conjugate | In development |
Orion Corporation — Europe. In mid-2026 Shilpa Biologicals and Orion Corporation of Finland agreed co-development and exclusive European supply of a nivolumab biosimilar, with Orion responsible for European commercialisation. The nivolumab reference product addresses a European market of approximately USD 4.1 billion and a global market of approximately USD 12 billion.
SteinCares — Latin America. In February 2026 Shilpa Biologicals entered an exclusive biosimilar licensing agreement with SteinCares covering more than 30 Latin American countries. SteinCares manages registration and distribution; Shilpa Biologicals manufactures from Dharwad.
Stage | Capability |
|---|---|
| Cell line development | CHO and HEK platform selection, clone screening, stability studies, automated GMP cell banking |
| Upstream process development | Media and feed optimisation, fed-batch and perfusion, multi-parallel bioreactor screening, scale-up to 4,000 L single-use |
| Downstream process development | Capture and polishing chromatography, viral clearance, conventional and continuous chromatography, TFF |
| Analytical characterisation | Primary and higher-order structure, glycan profiling, charge variants, potency bioassays, forced degradation, comparability against reference product |
| Formulation | Excipient screening, aggregation and stability control, liquid and lyophilised presentations |
| Fill-finish | Vials, pre-filled syringes, RTU and RTS formats |
| Regulatory | Comparability strategy, EMA and emerging-market dossiers, clinical development support |
