- Enzene has received European Union (EU) GMP certification for its two Pune facilities, enabling commercial-scale biologics manufacturing and fill/finish services.
- The company is also preparing to launch a $50 million manufacturing facility in Hopewell, New Jersey, featuring its patented fully-connected continuous manufacturing (FCCM) platform.
Enzene has announced that its two facilities in Pune, India, have received European Union (EU) Good Manufacturing Practice (GMP) certification. The certification enables the company to supply commercial-scale microbial and mammalian drug substances, along with drug product fill/finish and packaging, to customers in the European market.
A company 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.”
Enzene’s Pune facilities offer fully integrated services aimed at addressing complex disease markets and supporting innovative treatments. The sites include the company’s modular EnzeneX 2.0 platform, which optimises biomanufacturing by reducing equipment footprint compared to conventional fed-batch systems. This platform allows for clinical-phase cGMP supply starting at a 30-litre scale and can expand flexibly through scale-on and scale-out options.
Looking ahead, Enzene is set to expand its global footprint with the upcoming launch of a $50 million manufacturing facility in Hopewell, New Jersey. This site will introduce Enzene’s fully-connected continuous manufacturing (FCCM) platform to the U.S. market, further strengthening its position in the biologics contract manufacturing sector.
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