Shilpa Biologicals Ltd, a material subsidiary of Shilpa Medicare Ltd, has commissioned a Good Manufacturing Practice (GMP)-compliant Antibody-Drug Conjugate (ADC) manufacturing facility designed to meet global regulatory standards.
The facility is fully operational, with GMP qualification protocols currently underway, paving the way for commercial-scale operations.
Integrated ADC capabilities
With the commissioning of the facility, Shilpa Medicare becomes one of the few companies in India offering end-to-end ADC drug substance development and manufacturing services.
The facility covers payload synthesis, linker development, monoclonal antibody production, ADC conjugation and purification. As a result, the company can provide integrated solutions to global pharmaceutical and biotechnology firms.
Management comment
“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,” said Shilpa Biologicals Ltd Chief Executive Officer Sridevi Khambhampaty.
“We now offer global biotech and pharma partners a uniquely integrated ADC facility built on our existing high-potency manufacturing expertise,” she added.
Head start
“India has the scientific talent and now, with this facility, the infrastructure as well to be a serious and trusted partner in global ADC Drug Substance manufacturing,” said Shilpa Medicare Ltd Managing Director Vishnukant Bhutada.
“Our 25-year legacy in high-potency manufacturing gives us a head start that very few can match. With the addition of this facility, we can provide a comprehensive one-stop solution to leading oncology innovators,” he added.
Strategic significance
ADC manufacturing requires specialised containment systems, advanced conjugation chemistry and stringent biologics purification processes. Therefore, the new facility strengthens Shilpa’s position in the high-value oncology manufacturing segment.
Furthermore, the project supports the company’s long-term strategy of becoming a globally relevant CDMO partner for advanced oncology drug substance manufacturing.