Shilpa Biologicals Commissions Integrated ADC Drug Substance GMP Manufacturing Facilities

Shilpa Biologicals Ltd., has commissioned a state-of-the-art Antibody–Drug Conjugate (ADC) GMP manufacturing facility, purpose-built and designed to meet global regulatory approval standards including the U.S. FDA, EMA, and other major health authority requirements. The facility is fully operational, with GMP qualification protocols now actively underway, with a clear path to commercial readiness. 

Sridevi Khambhampaty, CEO, Shilpa Biologicals Pvt Ltd commented, “The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity and this ADC drug substance facility adds a new sophisticated dimension to the capabilities of the Shilpa group, we now offer global biotech and pharma partners a uniquely integrated ADC facility built with the knowledge of our existing high potency manufacturing excellence.”

With this commissioning, Shilpa Medicare Ltd becomes one of the few companies in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing — encompassing payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale drug substance. The manufacture of ADC drug substance demands specialized cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification — all within a GMP-validated environment.  

This commissioning is part of Shilpa’s long-term strategy to become a globally relevant CDMO partner for advanced oncology ADC drug substance manufacturing and commitment to high-value biologics, complex oncology drug substance platforms, and innovation-driven GMP manufacturing.