Flagship Stelis Biopharma Facility Receives USFDA Approval for Pharmaceuticals Capabilities
Stelis Biopharma Limited (Stelis or Company), an emerging biopharmaceutical contract development and manufacturing organization (CDMO) and the biologics arm of Strides Pharma Science Limited (Strides, BSE: 532531 NSE: STAR), today announced have received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA or agency) for the Pharmaceutical Product (DP) Facility Inspection that was conducted at its flagship manufacturing site (Unit 2) in Bengaluru, India.
This result for the DP facility comes after the USFDA’s on-site pre-clearance inspection (PAI) at the flagship Stelis manufacturing facility for multiple partner product submissions to the agency. Unit 2 facility has high end automated DP lines integrated with isolators to convert drug substances (DS) into stable formulations and fill finish within the same facility in all injectable formats including cartridges, pens, auto-injectors and pre-filled syringes. , liquids and freeze-dried vials.
Arun Kumar, the Founder, commented on the development saying, “I am very pleased with the USFDA approval for DP capabilities at our flagship facility, a second major win after receiving EU-GMP approval in June. 2022. While these two results validate our GMP systems and world-class fabric, it accelerates our ability to secure the impending manufacturing services agreements for pre-commercial revenue USFDA EIR now also paves the way for revenue site business services over the next two quarters after our partners receive respective product approvals. We’ve had an exciting year so far, and we continue to deliver even better financial results as we accelerate and pull take advantage of the opportunities in the global CDMO landscape.
As a fully integrated biologics CDMO, Stelis can offer a full range of services from its Unit 2 facility. In addition to DP capabilities, the facility has proven technical expertise and capabilities to manufacture DS on microbial, mammalian and various other technology platforms with world-class cGMP, regulatory and quality systems. While microbial DS is already in service, mammalian DS capabilities designed on industry-leading single-use bioreactor (SUB) systems will be available to partners later this month (September 2022). Unit 2’s integrated capabilities provide significant operational flexibility, greater efficiency, and varied range within a single principle. Earlier in June 2022, the facility received European Union Good Manufacturing Practices (EU-GMP) approval.
Stelis continues to grow its customer base with global partnerships and the integration of new programs on the drug substance and drug product side. It remains a major player in biologic CDMO given its comprehensive capabilities, high quality systems and large commercial scale with over 48,000 liters of drug substance in all modalities and over 400 million units of capacity filling-finishing.
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