Enzene Receives EU GMP Certification for Its Facilities in India

Pune, INDIA – March 4, 2025 – Enzene, a pioneer in fully-connected continuous biologics manufacturing technology, today announced that its two facilities in Pune have received European Union (EU) GMP certification to provide commercial-scale microbial and mammalian drug substance supply and drug product fill/finish and packaging.

“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,” commented an Enzene spokesperson.

In addition to the above, Enzene’s facilities provide fully integrated services to address the market for challenging diseases and innovative treatments. Pune was also the first site in the company’s network to feature Enzene’s modular EnzeneX™ 2.0 platform, which reduces the equipment footprint compared with that of conventional fed-batch systems. It 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. Enzene will soon launch a new state-of-the-art $50-million manufacturing facility in Hopewell, New Jersey, introducing the company’s patented, fully-connected continuous manufacturing™ (FCCM™) platform to the U.S.

About Enzene

Enzene is a fully integrated, end-to-end CDMO with services spanning discovery, development, and commercial supply, operating integrated sites in Pune (India) and New Jersey (USA). As a pioneer in next-generation biologics technologies, Enzene is disrupting the existing biologics manufacturing paradigm with its patented EnzeneX™ technology, which was the first fully-connected continuous manufacturing™ (FCCM™) platform validated for commercial biologics supply.

We partner with innovators and biosimilar developers to deliver accelerated time-to-market, increased production yields, and cost reductions across a broad range of biologic modalities. Committed to pushing the boundaries of biologics manufacturing innovation, Enzene is striving to reduce monoclonal antibody production costs to below $40 per gram by 2025.

For more information on Enzene, please visit www.enzene.com