Enzene Biosciences Launches its First Manufacturing Base in the US, With Additional Plans to Establish Continuous Manufacturing Operations at its New Jersey Site

Widely recognized as a pioneer in continuous manufacturing, Pune-based Contract Development & Manufacturing Organization (CDMO), Enzene Biosciences has announced the launch of its first manufacturing site in the US, located in Hopewell (near Princeton, New Jersey). The site is expected to be ready in June 2024, and customers have already started to reserve capacities for continuous manufacturing and/or fed batch.

Designed to integrate the company’s patented EnzeneX continuous manufacturing technology platform, the plant is situated within the Princeton West Innovation Campus, at the heart of the US Northeast Corridor, within easy reach of several global biotech and pharmaceutical firms. This location is ideal for helping Enzene Biosciences serve emerging innovative, US-based biotech firms looking to benefit from the in-depth expertise in continuous manufacturing.

Commenting on the rationale behind setting up its first manufacturing base in the US, Dr. Himanshu Gadgil, CEO, Enzene Biosciences, said “While the USA is home to most of the novel molecules that are the principle ingredients in creating many life-saving drugs, most of them have been developed by small biotech firms and start-ups that struggle to find clinical phase capacity. Recognizing this gap and driven by our fundamental mission of creating access equity across the global healthcare ecosystem, Enzene Inc. has been launched in the US to establish a state-of-the-art manufacturing plant to cater to small and mid-sized biotech companies. We have successfully identified, leased, and set up our first manufacturing facility in the states in record time. We remain confident that our proprietary EnzeneX technology platform and proven track record in achieving cost-effective biologics manufacturing will see us emerge as a partner of choice for biotech companies as we support them in bringing promising molecules to market.”

Spread over 54,000 sq ft, this plant will also hold the distinction of being one of the only biologics-focused continuous manufacturing bases to be set up by an Indian firm in the US. The company narrowed down on New Jersey because of its long tradition of supporting pharmaceutical manufacturing excellence. There is also ample availability of highly skilled talent in the region and Enzene Inc. is confident of securing skilled labor for sustained manufacturing operations over the longer term.

Elaborating on the organization’s growth strategy, Mr. Sandeep Singh, MD- Alkem Industries, said “Operating as an independent center within Alkem Laboratories, Enzene Biosciences has always been committed to delivering trusted and affordable solutions that can positively impact the global healthcare ecosystem. This vision continues to drive the company’s strategic expansion plans and has stimulated Enzene Biosciences to enter the U.S. CDMO space. In fact, with the company already supporting global pharmaceutical firms through its CDMO operations in India, the time was ripe for setting up a GMP-compliant continuous manufacturing base. The focus will now be on shoring up Enzene’s manufacturing capacities at the Hopewell plant and to create access equity for early-stage biological assets by providing cost-effective, yet quality local manufacturing.”

Having already inaugurated its cutting-edge R&D facility in Pune, the company’s primary focus in the near term is expanding into discovery-focused capabilities, enhancing manufacturing capabilities, and securing USDA and USFDA approval for the US facility within the next year. Ultimately, Enzene Biosciences aims to gradually expand its operations across the five major markets for biologics and biosimilars, ie, the EU, US, Canada, Australia, and Japan, with the ulterior objective being to establish itself as the number one Indian biotech company catering to a global client base.

Enzene is an innovation-driven biotech company and a subsidiary of Alkem Laboratories Ltd (one of the top five pharmaceutical companies in India), located in Pune, India, Enzene’s focus lies in producing biosimilars, novel biologics, synthetic peptides, and phytopharmaceuticals. Enzene also offers a range of CDMO and CMO services in biologics. For more information, visit www.alkemlabs.com. For more information on Enzene Biosciences, visit www.enzene.com.