- Shilpa Biologicals has announced a new bioconjugation suite at its Dharwad site, set to be operational by September 2025.
- The suite will enable integrated ADC manufacturing by combining payloads, monoclonal antibodies, and bioconjugation on a single campus.
Shilpa Biologicals, a full-service contract development and manufacturing organisation (CDMO), has announced the addition of a dedicated bioconjugation suite at its Dharwad campus in India. The facility is currently undergoing validation and is expected to start onboarding client programmes by September 2025.
The new suite is situated adjacent to Shilpa’s existing commercial biologics manufacturing plant, and will enable clinical and commercial-scale production of antibody-drug conjugates (ADCs) within a fully integrated site. This positions Shilpa among a small group of global CDMOs offering end-to-end ADC capabilities—from payloads and linkers to monoclonal antibodies and bioconjugation.
According to the company, the expansion includes 200L single-use bioconjugation reactors and lyophilisation capacity of up to 65 kg. It is supported by complementary development laboratories for process development, analytical characterisation, and scale-up. Shilpa’s Hyderabad site will continue to provide isolator-based fill-finish services for cytotoxic products.
The Dharwad facility is backed by one of the industry’s largest linker and payload libraries, as well as 10 cGMP high-potency active pharmaceutical ingredient (HPAPI) suites. These suites are designed for compounds with occupational exposure limits (OELs) below 0.01 µg/m³, enabling the safe processing of potent payloads used in oncology.
Dr. Sridevi Khambhampaty, CEO of Shilpa Biologicals, stated: “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.”
