Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation

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Stelis Biopharma Limited , an emerging biopharmaceutical and vaccine Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited , today announced that it had received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary for two of its manufacturing facilities.

Stelis’ flagship facility (Unit 2, Bengaluru, India) is an integrated state-of-the-art manufacturing setup that leverages microbial and mammalian platforms for developing and commercializing biologics and biosimilars in multiple fill-finish formats, including cartridges, devices, pre-filled syringes, liquid, and lyophilized vials. The facility has the most modern equipment setup, including the use of industryleading technologies like single-use bags and isolator-based manufacturing, offering significant operational flexibility.

Stelis’s small-scale cGMP manufacturing facility (Unit 1, Bengaluru, India) is designed to support smallscale commercial and cGMP clinical trial material generation and initial technology transfer activities across multiple modalities. The facility is equipped with high-throughput instrumentation that offers different analytical developmental and characterization services for a wide range of biopharmaceutical products conforming to global regulatory standards throughout their lifecycle.

As an emerging CDMO partner for the global biopharmaceutical industry, Stelis is committed to offering end-to-end solutions for developing and commercializing biologics, biosimilars, and vaccines. The company has recently entered into marquee international partnerships and gained comprehensive experience in manufacturing biologics for diabetes, osteoporosis, and other therapeutic categories using mammalian and microbial systems from the pre-clinical stage through commercialization. With over US$ 300 million in investments, Stelis has built a robust CDMO platform that offers one of APAC’s largest drug substance capacities with over 48,000L across various modalities and drug product capacities exceeding 400 million units per annum.