Enzene Secures EU GMP Certification to Expand Global Biologics Capabilities

End-to-end CDMO, Enzene, has announced EU GMP certification for its two facilities in Pune, India, to provide commercial-scale microbial and mammalian drug substance supply, and drug product fill/finish and packaging. Demonstrating its commitment to EMA standards, the company believes the certification is the next step in its journey towards providing clients with comprehensive CDMO solutions.

Enzene’s Pune facilities offer fully integrated services for innovative treatments and includes the EnzeneX™ 2.0 platform to optimize biomanufacturing efficiency with a smaller footprint and flexible bioreactor capacity. In the future, the company plans to launch a new state-of-the-art USD 50 mn manufacturing facility in Hopewell, New Jersey, introducing the company’s patented, fully-connected continuous manufacturing™ (FCCM™) platform to the U.S.

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.

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