Enzene Biosciences has established its first manufacturing facility outside India with the opening of a $50 million biopharmaceutical plant in Hopewell, New Jersey, on the Princeton West Innovation Campus. The facility represents a significant expansion for the Contract Development and Manufacturing Organization (CDMO), which is a subsidiary of Alkem Laboratories, Ltd.
Advanced Manufacturing Platform
The 54,000-square-foot facility features Enzene's proprietary EnzeneX™ technology, described as the first fully-connected continuous manufacturing (FCCM) platform validated for commercial biologics supply. This platform is designed to provide flexibility and lower manufacturing costs compared to traditional batch processing methods.
"Existing and new customers see the powerful opportunities that continuous biologics technology brings, not least by providing flexibility and lowering the cost of manufacturing," said Norm Stoffregen, who was appointed as SVP, site head, and head of biologics manufacturing at the facility.
The Princeton site includes development and quality laboratories, warehousing, frozen storage, and cell banking capabilities, complementing Enzene's global network and benefiting from process development expertise developed at the company's facility in Pune, India.
Leadership and Expansion Plans
Stoffregen brings extensive experience to his role, having worked in the biologics manufacturing area since 2015 when the Hopewell facility was owned by Bristol Myers Squibb. He previously served as VP-site head at PTC Therapeutics and held various roles at BMS and other biotherapeutics companies, accumulating more than 20 years of experience in leadership, quality assurance, and Chemistry, Manufacturing and Controls (CMC).
"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," commented Dr. Himanshu Gadgil, CEO of Enzene Biosciences.
Employment and Growth Projections
The company initially hired 50 employees and plans to grow to 300 employees at the New Jersey facility by the end of 2025. Operations at the facility began in June 2024, with plans to transfer existing customers' manufacturing projects and expand bioreactor capacity.
Stoffregen indicated that the company is already in discussions with biopharma companies interested in progressing programs for the domestic market and beyond, with expectations to ramp up production capacity and capabilities over the next 18 months.
Cost Reduction Goals
Enzene has set an ambitious target to reduce monoclonal antibody production costs to below $40 per gram by 2025 through its innovative manufacturing approach. The company positions itself as disrupting the existing biologics manufacturing paradigm with its continuous manufacturing technology.
"We are excited to provide them with access to our cutting-edge continuous manufacturing platform, which enables streamlined and efficient production processes," said Dr. Gadgil, referring to the company's North American clients.
Strategic Location Benefits
Wesley Mathews, President and CEO of Choose New Jersey, highlighted the state's advantages for biopharmaceutical companies: "New Jersey's highly skilled workforce, state-of-the-art infrastructure, and renowned academic institutions make it an ideal location for Enzene, ensuring that we can deliver exceptional services and support to our clients in the U.S."
The facility expansion demonstrates the growing New Jersey-India economic partnership in the life sciences sector, with Enzene joining other Indian biopharma companies that have established operations in the state.
