Shilpa commissions ADC facility

India’s Shilpa Biologicals has announced the commissioning of a GMP antibody–drug conjugate (ADC) facility. The company said that the facility is “purpose-built and designed to meet global regulatory approval standards”. It is fully operational, with GMP qualification protocols underway.

Shilpa Biologicals’ parent company, Shilpa Medicare, has invested heavily in highly potent compound manufacturing over the past 25 years. With this facility, it claims to “one of the very few companies in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing”, including payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation and the purification of GMP-scale drug substance.