Integrated biologics R&D and manufacturing campus at Dharwad, Karnataka — biosimilars, ADCs, recombinant proteins and clone-to-vial biologics CDMO.
Shilpa Biologicals Private Limited operates an integrated biologics R&D and manufacturing campus at Plot 532/A, Belur Industrial Area, Dharwad, Karnataka, India – 580011.
The Dharwad campus is a fully integrated biologics CDMO, supporting projects from early development through drug-substance manufacturing, drug-product development, fill-finish and packaging — combining R&D, analytical development, manufacturing and quality-control infrastructure to take biologic products from concept through commercialization. The campus supports biosimilars, novel biologic entities, vaccines, antibody-drug conjugates (ADCs), recombinant proteins and other complex biologics, across both mammalian and microbial platforms.
Shilpa Biologicals Private Limited, Plot No. 532/A, Belur Industrial Area, Dharwad – 580011, Karnataka, India.
Scale | Detail |
|---|---|
| Small-volume manufacturing | 50 L and 200 L bioreactors, with and without perfusion |
| Large-volume manufacturing | 2 × 2,000 L and 4 × 1,000 L bioreactors — 8,000 L total installed capacity |
| Planned expansion | Up to 16,000 L capability |
DP Capability | Capacity |
|---|---|
| Small-volume PFS / Vial | 20 units/min |
| Large-volume PFS/Vial with isolator | 40 units/min |
| High-volume vial filling | 300 units/min |
| Vial sizes | 2R to 100R |
Shilpa Biologicals’ scientific team covers molecular biology, biochemistry, immunology, formulation sciences, process development, process characterization, scale-up, analytical development, fill-finish development, quality control and regulatory support — including transient and stable cell-line development and analytical-method development and qualification for comprehensive protein characterization.
Supported biologic modalities:
Monoclonal antibodies · non-mAb biologics · biosimilars · fusion proteins · bispecific antibodies · recombinant proteins · glycoproteins · PEGylated proteins · enzymes · hormones · antigens · mRNA · multimeric protein complexes · ADCs · vaccines · recombinant human albumin
Cell & process development
Engineered CHO cell lines, engineered yeast strains, proprietary vector constructs, media-component development, cell banking, cell-line characterization.
Bioreactor / process platforms
Ambr® 15 mL micro-bioreactors for high-throughput screening; 2 L and 10 L glass fermenters; 50 L single-use bioreactors; 1,000 L and 2,000 L single-use bioreactors; fed-batch and continuous perfusion processing — applicable to monoclonal antibodies, fusion proteins and glycoproteins.
One of the major recent expansions at Dharwad is the integrated ADC capability. In 2025, Shilpa Biologicals announced a dedicated bioconjugation suite at its Dharwad campus, adjacent to the existing commercial biologics manufacturing facility — integrating payloads and linkers, monoclonal antibodies, and bioconjugation, positioning Dharwad to provide integrated ADC development and manufacturing across early-stage development through clinical and commercial manufacturing.
Dedicated R&D laboratories, analytical-development laboratories, quality-control laboratories, manufacturing lines, drug-substance manufacturing infrastructure, drug-product / fill-finish suites, packaging facilities, cell banking and characterization capabilities, single-use bioreactor infrastructure, cold-chain storage and warehousing. Two warehouse facilities total more than 1,200 m².
Cold-chain infrastructure
−20°C walk-in freezer: 150 KL · −20°C walk-in freezer: 19.2 KL · 2–8°C walk-in cold room: 93 KL · 2–8°C DS cold room: 26.2 KL · two 2–8°C RM cold rooms: 25.2 KL · two RM quarantine/recall cold rooms: 9.6 KL · intermediate-product cold room: 17 KL.
Product | Code | Area / Application |
|---|---|---|
| Adalimumab Biosimilar | SBM-01 | Rheumatology, Dermatology, Gastroenterology, Ophthalmology |
| Aflibercept Biosimilar | SBM-02 | Ophthalmology |
| Recombinant Human Albumin | SBM-03 | Blood-volume expansion, infusion therapy |
| FC Fusion Protein Biosimilar | SBM-04 | Rheumatology |
| mAb Biosimilar | SBM-05 | Oncology |
| mAb Biosimilar | SBM-06 | Oncology |
| Peptide-ARBM 101 | SBM-07 | Client confidential |
DSIR-recognised in-house R&D unit · GLP laboratory certification (BSI) · GMP certificate · ISO 9001:2015 · ISO 14001:2015 · ISO 45001:2018.
A Karnataka Drugs Control Department GMP certificate identifies Shilpa Biologicals at Plot 532-A, Belur Industrial Area, Dharwad and confirms compliance with Schedule M GMP requirements under the relevant manufacturing licence. An ISO 9001:2015 certificate published by Shilpa Biologicals covers the development, manufacturing and supply of biopharmaceuticals and vaccines.
