Stelis Biopharma gets EU cGMP accreditation for two biologics manufacturing facilities

GMP approval was received both for the flagship facility and small-scale commercial and clinical batch manufacturing facility

Stelis Biopharma has 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.

Commenting on the update, Arun Kumar, Founder, said, “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.”

Stelis’ flagship facility (Unit 2, Bengaluru, India) leverages microbial and mammalian platforms for developing and commercialising biologics and biosimilars in multiple fill-finish formats, including cartridges, devices, pre-filled syringes, liquid, and lyophilised vials. The facility uses leading technologies like single-use bags and isolator-based manufacturing, offering significant operational flexibility, as per a company statement.

The statement also adds, “Stelis’s small-scale cGMP manufacturing facility (Unit 1, Bengaluru, India) is designed to support small scale 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 characterisation services for a wide range of biopharmaceutical products conforming to global regulatory standards throughout their lifecycle.”

Biologics CDMOcGMP manufacturing facilityEU GMPEuropean Union Goods Manufacturing PracticesNational Institute of Pharmacy and NutritionStelis Biopharma
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