Enzene has received European Union (EU) Good Manufacturing Practice (GMP) certification for its two facilities in Pune, India, allowing the company to supply microbial and mammalian drug substances — as well as drug product fill-finish and packaging — for commercial use in the EU markets.
The certification confirms compliance with the European Medicines Agency’s (EMA) quality and safety standards and enables Enzene to expand its reach in global biologics manufacturing. The Indian facilities incorporate the company’s manufacturing platform, designed to reduce equipment footprint compared with that of conventional fed-batch systems, and offers flexible bioreactor capacity for clinical and commercial production.
According to the company, Pune was the first network site to feature its modular EnzeneX 2.0 platform, which is “capable of clinical phase cGMP supply from as low as 30-liter scale, with variable bioreactor capacity to accommodate scale-on and scale-out expansion.”
Beyond its operations in India, Enzene is preparing to open a new $50 million manufacturing facility in Hopewell, New Jersey. The site will introduce the company’s continuous manufacturing platform, which aims to streamline biologics production.
Enzene has positioned itself as a fully integrated, end-to-end contract development and manufacturing organization (CDMO) with a focus on next-generation biologics technologies. With integrated sites in India and the United States, Enzene provides services across drug discovery, development, and commercial supply.
The company has indicated plans to continue advancing biologics manufacturing with its proprietary continuous manufacturing approach, targeting increased efficiency and cost reductions in monoclonal antibody production. Enzene’s stated goal is to reduce monoclonal antibody production costs to below $40 per gram.