Enzene appoints new site lead for flagship US continuous biomanufacturing facility

Hopewell, New Jersey – September 3, 2024 – Enzene Biosciences, a fully integrated CDMO with services spanning discovery, development and commercial supply, today announced the appointment of Norm Stoffregen as SVP, site head, and head of biologics manufacturing at the company’s new $50 million manufacturing facility in Hopewell, near Princeton, New Jersey.

As well as taking responsibility for Enzene’s global biologics business, Stoffregen will lead the final stages of work to commission the 54,000-square-foot facility. He will then lead ongoing operations at the site, where the company intends to transfer-in existing customers’ manufacturing projects and expand to add further bioreactor capacity, employing a workforce of 300 by the end of 2025. Significantly, Stoffregen brings a vast experience of building manufacturing businesses, having worked in the area since 2015 when the Hopewell facility was owned by Bristol Myers Squibb.

“I am delighted to welcome Norman to Enzene,” commented Himanshu Gadgil, CEO of Enzene Biosciences. “His knowledge of the facility, our colleagues, customers and suppliers will be invaluable as we develop our customer base and expand operations, further building our reputation as a world class biologics innovator dedicated to lowering the cost of biologics production, and continually improving manufacturing techniques.”

The Princeton site features EnzeneX™, the company’s fully-connected continuous manufacturing platform, as well as development and quality laboratories, warehousing, frozen storage and cell banking. When complete, it will complement Enzene’s global network and benefit from process development expertise and the proven and flexible continuous manufacturing capabilities first developed at the company’s facility in Pune, India.

“Existing and new customers see the powerful opportunities that continuous biologics technology brings, not least by providing flexibility and lowering the cost of manufacturing,” commented Stoffregen. “We are already in discussion with biopharma companies keen to progress programs for the domestic market and beyond, and in the next 18-months we expect to ramp up our production capacity and capabilities, and grow our pipeline of work with biotech and pharma companies in early phases of development.”

Immediately prior to joining Enzene, Stoffregen was VP-site head at PTC Therapeutics, and before that held various roles of increasing responsibility at BMS and with other biotherapeutics/bioprocessing companies, where he amassed more than 20-years’ experience in leadership, quality assurance, and Chemistry, Manufacturing and Controls (CMC). Stoffregen has a bachelor’s from the State University of New York at New Paltz.

About Enzene Biosciences

Enzene Biosciences is an 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—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 Biosciences Ltd., a subsidiary of Alkem Laboratories Ltd, please visit www.enzene.com