Shilpa Biologicals
Shilpa Biologicals is a leading innovator in biologics manufacturing, specializing in biosimilars, vaccine development, fusion proteins, and blood-product therapies. With state-of-the-art facilities and a talented team of scientists, the company is committed to making high-quality, affordable therapies accessible worldwide. Their expertise spans from early-stage research to large-scale commercial manufacturing, with a focus on immunology and hematology. Strategic partnerships with global pharma companies underscore their role as a trusted CDMO and biologics innovator.
Industries
Nr. of Employees
medium (51-250)
Shilpa Biologicals
Products
Adalimumab biosimilar (anti‑TNF monoclonal antibody)
High‑concentration adalimumab biosimilar developed for subcutaneous administration in prefilled syringes; completed Phase 3 clinical studies and received market authorization in a referenced market.
Aflibercept biosimilar (ophthalmology fusion protein)
Biosimilar development program for an ophthalmology‑targeted recombinant fusion protein intended to provide VEGF inhibition; clinical development initiated.
Recombinant human albumin platform
Recombinant albumin produced via a synthetic/fermentation route intended for therapeutic and excipient uses; development includes a patented manufacturing process and large‑scale scale‑up programs.
Pipeline of monoclonal antibody and Fc‑fusion biosimilars
Multiple monoclonal antibody and Fc‑fusion biosimilar programs across oncology, immunology and ophthalmology with supporting process development and comparability studies.
Adalimumab biosimilar (anti‑TNF monoclonal antibody)
High‑concentration adalimumab biosimilar developed for subcutaneous administration in prefilled syringes; completed Phase 3 clinical studies and received market authorization in a referenced market.
Aflibercept biosimilar (ophthalmology fusion protein)
Biosimilar development program for an ophthalmology‑targeted recombinant fusion protein intended to provide VEGF inhibition; clinical development initiated.
Recombinant human albumin platform
Recombinant albumin produced via a synthetic/fermentation route intended for therapeutic and excipient uses; development includes a patented manufacturing process and large‑scale scale‑up programs.
Pipeline of monoclonal antibody and Fc‑fusion biosimilars
Multiple monoclonal antibody and Fc‑fusion biosimilar programs across oncology, immunology and ophthalmology with supporting process development and comparability studies.
Services
End‑to‑end CDMO biologics services
Integrated services from cell line and process development through analytical characterization, formulation, aseptic fill–finish and GMP manufacture of drug substance and drug product for clinical and commercial supply.
Cell line and in‑house cell banking services
Transient and stable cell line development, clone selection, research/master/working cell bank preparation and in‑house cell line characterization to support biologics production.
Process development, MSAT and technology transfer
Upstream and downstream process optimization, scale‑down modelling, pilot runs, engineering batches and structured technology transfer to commercial manufacturing with process validation support.
Analytical development, characterization and stability testing
Development, qualification and validation of analytical methods (HPLC/UPLC, MS, CE), bioassays, glycan profiling and stability studies to support lot release, comparability and regulatory filings; ICH‑compliant stability programs.
HPAPI, bioconjugation and ADC development services
Containment‑rated HPAPI suites, payload/linker handling, single‑use bioconjugation reactors and downstream processing including lyophilization to support ADC development from early‑stage to commercial supply.
Vaccine and viral vector contract manufacturing
Contract manufacture of vaccine and viral‑vector drug substance including process development, characterization, virus purification and GMP production for pandemic and routine vaccine supply.
End‑to‑end CDMO biologics services
Integrated services from cell line and process development through analytical characterization, formulation, aseptic fill–finish and GMP manufacture of drug substance and drug product for clinical and commercial supply.
Cell line and in‑house cell banking services
Transient and stable cell line development, clone selection, research/master/working cell bank preparation and in‑house cell line characterization to support biologics production.
Process development, MSAT and technology transfer
Upstream and downstream process optimization, scale‑down modelling, pilot runs, engineering batches and structured technology transfer to commercial manufacturing with process validation support.
Analytical development, characterization and stability testing
Development, qualification and validation of analytical methods (HPLC/UPLC, MS, CE), bioassays, glycan profiling and stability studies to support lot release, comparability and regulatory filings; ICH‑compliant stability programs.
HPAPI, bioconjugation and ADC development services
Containment‑rated HPAPI suites, payload/linker handling, single‑use bioconjugation reactors and downstream processing including lyophilization to support ADC development from early‑stage to commercial supply.
Vaccine and viral vector contract manufacturing
Contract manufacture of vaccine and viral‑vector drug substance including process development, characterization, virus purification and GMP production for pandemic and routine vaccine supply.
Expertise Areas
- Cell line development and characterization
- Upstream and downstream bioprocess development
- Continuous bioprocessing and perfusion systems
- Biologics and biosimilar process development
Key Technologies
- ATF and perfusion bioprocessing
- Fed‑batch and high‑density fermentation
- Single‑use and stainless‑steel bioreactors (bench to multi‑kL)
- Continuous purification and multi‑mode chromatography