Enzene Secures EU GMP Certification For Its India Facilities, Expanding Biologics Manufacturing Capabilities

Enzene, a leader in continuous biologics manufacturing, has received European Union (EU) Good Manufacturing Practice (GMP) certification for its two facilities in Pune. This certification enables the company to supply commercial-scale microbial and mammalian drug substances, as well as provide drug product fill/finish and packaging services. 

Enzene spokesperson commented, “The European Union’s GMP certification provides existing and potential customers with tangible evidence that Enzene meets the stringent quality and safety standards required by the European Medicines Agency, and marks another step on Enzene’s journey to providing comprehensive solutions to clients in Europe and beyond.”

The facilities from Enzene operate with integrated services to tackle demanding diseases and treatment innovations across markets. The facility at Pune became the initial location within Enzene's network to implement EnzeneX™ 2.0, which uses limited equipment in comparison to traditional fed-batch systems. The system generates clinical phase cGMP produced at a starting volume of 30 litres and provides an adjustable bioreactor capacity to handle both production expansions. The newly constructed $50-million state-of-the-art Enzene manufacturing site located in Hopewell, New Jersey, will utilize patented Fully-Connected Continuous Manufacturing™ (FCCM™) technology to the United States.