News | June 16, 2022

Stelis Biopharma's Two Biologics Manufacturing Facilities Receive EU cGMP Accreditation

  • GMP approval was received both for the flagship facility and small-scale commercial and clinical batch manufacturing facility.
  • Flagship facility offers integrated microbial and mammalian platforms for biologics development and commercial manufacturing, along with the capability to convert drug substance to stable formulations and fill and finish in all injectable formats.
  • Small-scale drug substance manufacturing facility is suited for early-stage clinical trial material generation and commercial manufacturing, including initial technology transfer activities across multiple modalities.

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, 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.

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 $85M 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) 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$ 300M 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.

Source: Stelis Biopharma Limited.