Shilpa Biologicals Commissions GMP-Compliant ADC Manufacturing Facility
Shilpa Biologicals has commissioned a Good Manufacturing Practice (GMP) compliant antibody-drug conjugate (ADC) manufacturing facility. The facility is now fully operational, while GMP qualification protocols remain in progress.
The plant has been designed to support development and manufacturing of high-quality ADC drug substances for global pharmaceutical and biotechnology companies. It is backed by parent company Shilpa Medicare, which has invested in highly potent compound manufacturing over the past 25 years.
The facility offers end-to-end ADC manufacturing capabilities spanning payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale drug substances. This integrated setup is intended to help customers streamline development timelines while meeting regulatory requirements.
With this commissioning, Shilpa Biologicals positions itself among a small number of companies in India offering comprehensive ADC drug substance development and manufacturing services under one roof, catering to rising global demand for targeted cancer therapies.