Enzene Biosciences, a subsidiary of Alkem Labs, has launched its inaugural manufacturing facility in New Jersey, USA, marking its foray into the contract development and manufacturing organization (CDMO) sector. Situated within the Princeton West Innovation Campus, the plant is slated for completion by June 2024. Enzene aims to collaborate with US biotech firms, offering support in bringing promising molecules to market.
Strategically positioned in the US Northeast Corridor, Enzene’s facility enjoys proximity to numerous biotech and pharmaceutical companies, attracting early interest from clients reserving capacities for continuous manufacturing and fed-batch processes.
Himanshu Gadgil, CEO of Enzene Biosciences, highlights the critical need for additional manufacturing capacity to accommodate novel molecules developed by small biotech firms, a gap Enzene seeks to address with its US expansion.
Sandeep Singh, managing director of Alkem Industries, underscores Enzene’s commitment to providing affordable healthcare solutions globally, a vision driving its strategic expansion into the US CDMO landscape. With established CDMO operations in India, Enzene recognizes the opportune moment to establish a GMP-compliant continuous manufacturing base in the US.
Enzene’s investment of $50 million signifies its dedication to the US market, positioning itself as one of the few Indian firms establishing a biologics-focused continuous manufacturing base in the country. The facility will house multiple manufacturing lines utilizing EnzeneX, the company’s continuous manufacturing technology platform.
In addition to meeting immediate manufacturing needs, the New Jersey plant is poised for future expansions. Enzene aims to secure USDA and USFDA approvals within the next year, paving the way for its gradual expansion across major markets, including the EU, USA, Canada, Australia, and Japan, for biologics and biosimilars.
Enzene’s biosimilar portfolio encompasses a range of treatments targeting osteoporosis, cancer, immune disorders, and macular degeneration, with several products under development for the US and European markets, awaiting regulatory approvals.
