Stelis Biopharma receives EU-GMP certification for two of its manufacturing facilities

Stelis Biopharma, the biologics arm of Strides Pharma Science 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 industry leading 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.

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