Enzene Biosciences, a Pune-based biopharmaceutical and contract development and manufacturing organization (CDMO), has launched its first manufacturing site in New Jersey, the United States. Enzene is a subsidiary of the pharma company Alkem Labs.
Enzene’s US plant is located within the Princeton West Innovation Campus and expected to be ready in June 2024. Enzene is looking to become a CDMO partner for US biotech firms and help them bring promising molecules to market.
This location is at the heart of the US Northeast Corridor, within easy reach of several global biotech and pharmaceutical firms. Customers have already started to reserve capacities for continuous manufacturing and/or fed-batch, the company said.
Himanshu Gadgil, CEO, Enzene Biosciences, said while the USA is home to most of the novel molecules that are the principal 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. “Recognising this gap, Enzene has been launched in the US to establish a manufacturing plant to cater to small and mid-sized biotech companies,” Gadgil said.
Sandeep Singh, managing director, Alkem Industries, said Enzene has been operating as an independent centre within Alkem Laboratories and was focused on delivering affordable solutions that can positively impact the global healthcare ecosystem. This vision was driving the company’s strategic expansion plans and has stimulated Enzene Biosciences to enter the US CDMO space, Singh said. Enzene was already supporting global pharmaceutical firms through its CDMO operations in India and the time was ripe for setting up a GMP-compliant continuous manufacturing base, he added.
Enzene is investing $50 million to foray into the US market. This plant is one of the only biologics-focused continuous manufacturing bases to be set up by an Indian firm in the US. The company will host multiple manufacturing lines of its continuous manufacturing technology platform, EnzeneX at the site.
Enzene’s New Jersey plant will also cater to future expansion plans. The company’s focus in the near term is enhancing manufacturing capabilities and securing USDA and USFDA approval for the US facility within the next year. Enzene Biosciences aims to gradually expand its operations across the five major markets — EU, USA, Canada, Australia, and Japan for biologics and biosimilars, Singh said.
Biosimilars from Enzene include Teriparatide for osteoporosis, Cetuximab for head and neck cancer and colorectal cancer, Romiplostim for immune thrombocytopenic purpura, Denosumab (postmenopausal) osteoporosis and giant cell tumours of bone, Adalimumab (rheumatoid arthritis), Bevacizumab (metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastom) and Ranibizumab for diabetic macular oedema and age-related macular degeneration.
The company expects approvals for some of the products, which are currently under development for the US and European markets.