Shilpa Biologicals, an India-based biopharmaceutical manufacturing company and subsidiary of Shilpa Medicare, has commissioned a new antibody-drug conjugate (ADC) drug substance manufacturing facility designed to support development and GMP production for global pharmaceutical and biotechnology companies.

The facility is operational, with GMP qualification activities underway, according to the announcement. The company said the site was designed to meet regulatory requirements from agencies including the U.S. FDA and European Medicines Agency (EMA).

The integrated facility will support ADC drug substance manufacturing activities, including payload synthesis, linker manufacturing, monoclonal antibody production, as well as conjugation and purification. ADC manufacturing requires specialized handling of highly potent compounds, controlled processes and biologic purification capabilities, according to the company.

The new expands Shilpa Biologicals’ existing capabilities in high-potency compound manufacturing. The company said its experience with highly potent active pharmaceutical ingredients (APIs) provides a foundation for ADC manufacturing operations that require containment, safety controls, and regulatory compliance.

Shilpa Biologicals said the facility will allow it to support pharmaceutical and biotechnology companies developing oncology-focused ADC therapies by providing integrated development and manufacturing services.

The company contends that the investment strengthens its position as a contract development and manufacturing organization (CDMO) supporting complex biologic drug substance programs and advanced therapy manufacturing.

In related news, this week Shilpa Biologicals launched PartnerPower, a digital transparency platform designed to provide customers with real-time visibility into biologics development and manufacturing programs. The platform connects data across research, analytical development, and manufacturing operations to support project oversight, technology transfer, and regulatory readiness.