Advanced pharmaceutical solutions
Targeted • Precise • Effective
Integrated ADC capability from Shilpa Medicare — HPAPI payloads, linkers, monoclonal antibodies and GMP bioconjugation, all within one group.
Shilpa Medicare offers integrated antibody-drug conjugate manufacturing in which all four components come from within the group: high-potency cytotoxic payloads and linkers synthesised at Raichur, monoclonal antibodies produced at Dharwad, and GMP bioconjugation performed in an integrated ADC drug-substance facility commissioned at Dharwad in June 2026 with 200-litre single-use bioconjugation reactors and lyophilisation capacity to 65 kilograms.
An antibody-drug conjugate has four parts, and conventionally four suppliers:
Each interface is a comparability risk, a technology transfer, a quality agreement and a potential single point of failure. Sponsors managing ADC programmes routinely cite supply-chain fragmentation as their principal manufacturing risk. Timelines stretch; accountability blurs.
ADC Component | Where Shilpa Makes It | Capability |
|---|---|---|
| Monoclonal antibody | Shilpa Biologicals, Dharwad, Karnataka | CHO/HEK expression, 4,000 L single-use mammalian capacity, EU-GMP certified |
| Cytotoxic payload | Shilpa Pharma Lifesciences, Raichur, Karnataka | High-potency API manufacture in OEL-4 containment; multi-tonne HPAPI capacity; large in-house payload library |
| Linker | Shilpa Pharma Lifesciences, Raichur | Linker chemistry and PEG capability |
| Bioconjugation | Shilpa Biologicals, Dharwad | 200 L single-use bioconjugation reactors; GMP qualified |
| Lyophilisation & fill-finish | Shilpa Biologicals, Dharwad | Lyophilisation to 65 kg; three fill-finish suites including RTU vial and pre-filled syringe formats |
| Analytical characterisation | Dharwad + Nacharam, Hyderabad | Drug-to-antibody ratio determination, free drug analysis, aggregation, potency, LC-MS/MS bioanalysis |
The result: one organisation, one quality system, one point of accountability, for a complete ADC drug substance. Very few organisations anywhere can offer this. In India, the combination is close to unique.
Conjugation chemistry selection and optimisation through to formulation and stability.
GMP production spanning payload and linker through sterile fill-finish.
CMC and regulatory support for ADC drug substance and drug product.
Shilpa Medicare's integration also enables a genuinely rare capability: ADC biosimilar development. Two programmes are underway — trastuzumab emtansine and trastuzumab deruxtecan. Developing an ADC biosimilar requires simultaneous mastery of antibody, payload, linker and conjugation, which is why the field has so few participants.
End-to-end ADC development from feasibility through IND-enabling studies
Custom synthesis of cytotoxic payloads and linkers at Raichur
Isolator-based GMP facilities for highly potent ADC production
Explore Shilpa Biologicals' biosimilar pipeline and CDMO platform
