Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation
Bengaluru : Stelis Biopharma Limited (Stelis or Company), an emerging biopharmaceutical and vaccine Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science Limited on Thursday 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.
“The approval from EU-GMP is a significant first step in our journey to build a global biologics CDMO platform that offers end-to-end solutions across the modalities. Our facilities are designed to meet global regulatory standards, and as the other global inspections also come through, we would have all the necessary approvals to cater to global players. The last few quarters for our CDMO business have been eventful as we concluded various major contracts. These contracts have added new service revenues to our business and resulted in a commercial sales value of over $85 million in the peak year. The Global Biologics CDMO space remains exciting, and we are confident of delivering better financial outcomes for Stelis as we progress” Arun Kumar, Founder, said.
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.