Our facilities
With established sites in India and a strong focus on the USA and Europe, we are expanding into new geographies to establish ourselves as a leading CDMO provider.
Following the upcoming development of a new R&D and pharmaceutical manufacturing facility near Princeton, New Jersey, in the USA, we aim to create access equity for early-stage biological assets by offering cost-effective local manufacturing capabilities to companies working with novel molecules.
Enzene Receives EU GMP Certification for its Facilities in India
Enzene, a pioneer in fully-connected continuous biologics manufacturing technology, today announced that its two facilities in Pune have received European Union (EU) GMP certification to provide commercial-scale microbial and mammalian drug substance supply and drug product fill/finish and packaging.
India (Chakan, Pune)
State-of-the-art R&D facility
Our state-of-the-art R&D Pune spans over 75,000 square feet and is home to pioneering bioprocess manufacturing techniques. This facility allows us to offer fully integrated services, from cell line development to fill and finish, across a wide range of therapeutic modalities. These capabilities enable us to explore various aspects of drug development, including disruptive treatments for challenging diseases and innovative areas like antibody-drug conjugates (ADC) and cell and gene therapies (CGT).
Address: Plot No. A 22, A/1/2 Chakan Industrial Area, Phase 2, Khalumbre, Chakan, Pune, Maharashtra - 410501
Phone: 91-21-35614311
Email: info@enzene.com
State-of-the-art manufacturing facility
Enzene provides both microbial and mammalian manufacturing capabilities, with commercialized products from both verticals. Our facilities are designed to meet US FDA and EMA GMP standards. We offer six drug substance manufacturing suites capable of addressing both conventional (fed-batch) and continuous manufacturing, achieving capacities from 20L to 2000L and producing approximately 30kg of mAb per month. Drug substance manufacturing is supported by drug product fill and finish with fully automated filling of vials, prefilled syringes, and cartridges.
Enzene has obtained EU-GMP certification for its manufacturing facilities in India:
- Mammalian and Microbial Drug substance manufacturing facility
- Fill and finish/Drug product manufacturing facility
Address: Plot No. A 22, A/1/2 Chakan Industrial Area, Phase 2, Khalumbre, Chakan, Pune, Maharashtra - 410501
Phone: +91-21-35614311
Email: info@enzene.com
India (Bhosari, Pune)
US
New Jersey
Our US site in New Jersey significantly increases our capacity on the East Coast.
This state-of-the-art facility will feature Good Manufacturing Practice (GMP)-compliant drug substance manufacturing capabilities, along with supporting facilities such as a quality control laboratory, development laboratory, warehouse and temperature-controlled storage.
Address: Enzene Inc. Princeton West Innovation Campus 311 Pennington Rocky Hill Road, Building 21 Pennington, NJ 08534
Email: info@enzene.com
EnzeneX™
A platform that pushes your project further
Unlocking higher yields across a range of biologics at significantly lower costs to you, our patented continuous bioprocess manufacturing platform EnzeneX™ represents the pinnacle of our ongoing commitment to innovation.
CDMO solutions
Our suite of CDMO solutions is designed to provide everything you need, from cell line development to fill and finish. With a fully-integrated approach to your product, we provide you with a single, direct and streamlined route to market.
Join the revolution
Fueled by our continuous innovation and armed with EnzeneX™, our fully-integrated CDMO solutions and our biosimilars pipeline are designed to help bring your biologics innovations to life.