Enzene’s India site secures GMP, eyes US growth

The facilities, spanning 135,000 square-feet, offer microbial and mammalian manufacturing. With six suites supporting fed-batch and continuous processes (20 L – 2000 L), it can produce up to 30 kg of monoclonal antibody (mAb) per month. Its drug product facility provides automated vial, syringe, and cartridge filling. The facilities hold EU-GMP certification for both drug substance and fill/finish manufacturing.

“With our Pune facility now certified by the EMA, Enzene is well-positioned to accelerate its global growth trajectory. This certification opens new pathways for supplying biologics to regulated markets across Europe and beyond,” a spokesperson for the firm told BioProcess Insider.

“In India, our long-term plan is to continue strengthening our capabilities across discovery, development, and manufacturing, with a particular focus on scaling our fully connected continuous manufacturing (FCCM) technology.”

The EnzeneX 2.0 platform with FCCM technology, cutting production costs by 50%. Initially scaled at 200 L – 500 L, the platform’s capacity has expanded to 1,000 L, and this year the firm expects to produce up to 40 kg per thousand-liter batch at $40 per-gram.

According to the firm, EnzeneX 2.0 integrates advanced automation, AI, and machine learning to enhance process efficiency, maintain quality, and reduce waste. “Its predictive analytics optimize yield, minimize batch failures, and improve biologics production, including complex proteins.”

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Furthermore, the CDMO’s FCCM technology will soon be available to customers at its New Jersey site. Enzene, a subsidiary of India’s Alkem Laboratories, took its first steps outside India in June 2023, opening a biopharmaceutical manufacturing plant on the Princeton West Innovation Campus in Hopewell. In January 2024, the firm leased a 54,000 square-foot space in New Jersey for multiple manufacturing lines of its continuous manufacturing platform EnzeneX.

“In the US, we already have two operational production lines at our site in Hopewell, and the facility has space for four more. Our goal over the next two years is to have all six lines fully operational,” the spokesperson added.

“Given the global shortage in drug product supply, and especially with glucagon peptide-1 (GLP-1) drugs creating significant demand, we are also considering adding fill/finish capabilities at the site. We may explore further expansion too, potentially on the West coast or in Europe.”

Source : https://www.bioprocessintl.com/