Enzene Biosciences preps first US manufacturing site

Contract development manufacturing organization (CDMO) Enzene, a subsidiary of India’s Alkem Laboratories, announced in June 2023 it would take its first steps out of India and open a $50 million facility in Hopewell, New Jersey.

Now, the firm has divulged further details and said the plant has been designed to include the CDMO’s continuous manufacturing platform technology, EnzeneX. According to the company, the integration of EnzenzeX means the facility will be “one of the only” biologics-focused continuous manufacturing sites to be set up by an Indian company in the US.

“Compared to traditional manufacturing plants, Enzene’s new US facility will be capable of delivering higher production rates and will enable US-based clients to rapidly take their early/pre-clinical assets to the later stage of development or the commercial stage,” a spokesperson for Enzene told us.

“Continuous manufacturing is fully automated, enabling faster turnaround times and greater control over the manufacturing process. Compared to traditional manufacturing techniques Enzene can offer 10x higher productivity in upstream and 25-50% productivity in downstream. Quality is also improved as it minimizes product contact with cell culture fluid. The process is also more flexible and its modular design across an array of bio-reactor capacities enables accelerated development using scale-on and scale-out approaches, rather than scale-up.”

Ideal location

New Jersey is home to various life science firms, investments, and facilities. In Branchburg, New Jersey Eli Lilly has a 25,000 square-foot facility. In April 2022, CDMO Catalent paid Erytech $44.5 million for its 30,900 square-foot facility in Princeton. Additionally, PTC Therapeutics opened its gene therapy manufacturing facility in Hopewell, New Jersey in October 2021 to support production and research operations.

“Enzene wanted to increase its capacity, especially to meet the manufacturing demands of global clients in their time zones. The US site opening will help them further their mission to create access equity across the global healthcare ecosystem, and to cater to small and mid-sized businesses struggling to find clinical phase capacity,” the spokesperson said.

Enzene described the location as “ideal” and said it feels “confident” about hiring a skilled labor force because the area has a large talent pool. The CDMO said it expects to hire over 300 workers at the facility.

The site is anticipated to be fully operational in June and the firm said it has already begun to reserve capacity for continuous manufacturing and/or fed batch for customers.