Enzene Biosciences

Enzene Biosciences Contract Manufacturing & Development (CDMO) Profile

Enzene Biosciences is a leading global contract development and manufacturing organization (CDMO). The company was founded on a belief that we have a responsibility to positively impact healthcare around the world by providing the technological expertise, passion for innovation, and dedication to helping clients bring accessible and affordable products to market. Built on a proven history of successful commercial launches and a strong early-stage product pipeline, Enzene continues to disrupt the CDMO industry with novel processes that improve quality and productivity while reducing costs and carbon footprint.

Our comprehensive capabilities encompass R&D, analytics, and GMP manufacturing, empowering us to offer innovative, high-quality solutions that meet diverse client needs. By providing end-to-end CDMO services for biologics, from cell line development to fill & finish for complex molecules, we are a versatile CDMO partner for our clients across a wide array of modalities. And with multiple manufacturing lines at our Pune, India and New Jersey, USA facilities, Enzene is strategically positioned to meet the escalating demand for biologics and biosimilars across both hemispheres.

Additionally, our proprietary continuous manufacturing technology, EnzeneXâ„¢, sets us apart as visionaries in the industry, driving healthcare advancement and setting new standards for biologics development and manufacturing. The EnzeneXâ„¢ platform optimizes quality, efficiency, and flexibility while supporting cost-effective, sustainable production of top-tier biologics, thereby improving global patient access.

Enzene Biosciences was established in 2015 in a 25,000 square feet end-to-end clone to formulation facility in Pune, India. Enhancing its capabilities to seamlessly manage the entire bioprocessing workflow from cloning to clinic, this facility was complemented by a clinical manufacturing facility, further bolstering Enzene’s ability to conduct clinical trials and scale up production effectively. Our commercial success is evident through the commercial GMP certification for manufacturing E. coli and mammalian-based products, along with the successful commercialization of seven biosimilar products in under 3 years. Validating its rigorous standards and adherence to regulatory requirements, Enzene also delivered Phase I enabling GMP material for mAbs and complex multi-specific proteins, showcasing its expertise in early-stage development. The development of our patented and commercially validated technology for continuous manufacturing, EnzeneXâ„¢ and the establishment of a 1,35,000 square feet GMP continuous manufacturing facility for manufacturing mAbs and recombinant proteins underscored Enzene’s leadership in innovative manufacturing processes in the next few years.

Enzene’s global footprint is expanding with a new state-of-the-art R&D facility in India (75,000 sq. ft.) and a clinical-scale GMP facility in the US (54,000 sq. ft.), equipped with supporting labs and plans for multiple 500L and 2000L bioreactors to support clinical and commercial manufacturing. The company is also gearing up with an upcoming 200L scale in its microbial GMP facility, a discovery services unit, and registrations for key products like Denosumab, Teriparatide, and Liraglutide in major markets like the US and EU, signalling its readiness to serve diverse global markets with cutting-edge biopharmaceutical solutions. At Enzene, we are leaders who seek to solve today’s biotech challenges as well as tomorrow’s by upholding our core values of innovation, integrity, excellence, entrepreneurship, candor, and respect.

CDMO Services:
Biologics Cartridges; Liquids; Lyophilized amps/vials; Pre-Filled Syringes (PFS) Analytical Development; Cell Line Development; Formulation Development; Process Development; Protein Synthesis Antibodies; Antibody-drug conjugate (ADC); Fusion Proteins; Recombinants + other Proteins

Year Founded:

Head Office: Pune, India

Number of Facilities: 1-2

Facility locations: North America; South Asia

Website: Visit the Enzene Biosciences website

Linkedin: Connect on Linkedin