- Shilpa Biologicals has commissioned a GMP manufacturing facility for antibody-drug conjugates (ADCs) in Dharwad, India, designed to meet US FDA and EMA standards.
- The facility provides integrated ADC drug substance services, including payload synthesis, linker development, monoclonal antibody production, ADC conjugation, and purification.
Shilpa Biologicals Private Ltd, a subsidiary of Shilpa Medicare, has commissioned an antibody-drug conjugate (ADC) GMP manufacturing facility in Dharwad, India. The company said the facility has been designed to meet global regulatory standards, including those of the US FDA and EMA, and is fully operational with GMP qualification protocols currently underway.
The new facility expands the company’s capabilities in ADC drug substance development and manufacturing. According to Shilpa Biologicals, the site offers integrated services covering payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale drug substance. The company stated that this makes it one of the few companies in India offering end-to-end ADC drug substance manufacturing capabilities.
Shilpa Medicare said the investment builds on more than 25 years of experience in highly potent compound manufacturing through its High Potency API (HPAPI) platform. The company noted that the platform requires specialized containment and safety engineering to support the production of highly potent compounds.
“The manufacturing of highly potent compounds has been a core part of the company’s operations and that the ADC drug substance facility expands those capabilities for global partners seeking integrated development and manufacturing services.”
Sridevi Khambhampaty, CEO of Shilpa Biologicals Pvt Ltd
The company said the facility supports its strategy to expand biologics manufacturing and strengthen its position as a CDMO and contract manufacturing partner for global pharmaceutical and biotechnology companies developing oncology therapies. GMP qualification activities are ongoing as the company progresses toward commercial readiness.
