Shilpa Biologicals opens bioconjugation suite at Dharwad site

Published: 22-May-2025

The CDMO will now have commercial-scale capacity to manufacture all three core ADC components

CDMO Shilpa Biologicals has opened a dedicated bioconjugation suite at its Dharwad, India site. 

By building this new suite, Shilpa becomes one of a select group of CDMOs who are able to provide clinical and commercial-scale manufacturing across all three core antibody-drug conjugate (ADC) components — including payloads/linkers, monoclonal antibodies and bioconjugates.

By achieving this at a single integrated campus, the company can cater to the growing demand for ADC manufacturing, which is picking up steam in the oncology space. 

Located next to the company's existing commercial biologics manufacturing facility, the suite is backed by a sizable payload and linker library, with multi-tonne capacity for high-potency active pharmaceutical ingredient (HPAPI) capacity.

Shilpa's 10 cGMP HPAPI suites are equipped to handle compounds exposure limits (OELs) below 0.01 µg/m³, assuring employee safety during the processing of potent ADC payloads.

The multi-client bioconjugation suite also includes 200L single use bioconjugation reactors and a lyophilisation capacity of up to 65kg.

Complementary development laboratories positioned at the site will provide process development and analytical characterisation, as well as both early and late-stage scale-up capabilities.

For final dose requirements, Shilpa’s Hyderabad site is equipped with multiple isolator-based fill-finish lines dedicated to cytotoxic products.

“We are seeing an unprecedented wave of ADC innovation entering clinical development — yet only a handful of CDMOs globally offer true end-to-end capabilities," noted CEO of Shilpa Biologicals Dr Sridevi Khambhampaty.

"Our co-located ADC services — spanning payloads, linkers, antibodies, and bioconjugation — are generating significant industry interest, especially from US and European biotech companies seeking a single, reliable partner to support their journey from discovery to commercial launch.

The Dharwad suite is currently undergoing validation and is expected to begin operations by September 2025.

 

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