Stelis Biopharma Limited, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and biologics arm of Strides Pharma Science Limited, has received the Establishment Inspection Report (EIR) from U.S. Food and Drug Administration (USFDA) for the Drug Products (DP) facility inspection that was completed at its flagship manufacturing site (Unit 2) at Bengaluru, India.

This outcome for the DP facility comes after the USFDA on-site Pre-Approval Inspection (PAI) at Stelis flagship manufacturing facility for several product submissions by the partners to the agency. The 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, pen devices, auto-injectors, pre-filled syringes, liquid, and lyophilized vials.

Commenting on the development, Arun Kumar, Founder said, "I am very pleased with the USFDA nod for DP capabilities at our flagship facility, a second major win after receiving the EU-GMP approval in June 2022. While these two outcomes validate our GMP systems and Global Quality fabric, it fast-tracks our ability to close out on the impending manufacturing services agreements for the pre- commercial revenues. The EIR from USFDA now also paves the way for the commercial services revenue from the site in the next two quarters after our partners receive respective product approvals. We have had an exciting year so far, and we continue to deliver even better financial outcomes as we accelerate and build on the opportunities in the Global CDMO landscape.”

As a fully integrated biologics CDMO, Stelis can offer a complete spectrum of services from its Unit 2 facility. Besides the DP capabilities, the facility has proven technical expertise and capabilities to manufacture DS across microbial, mammalian, and various other technology platforms with world-class cGMP, regulatory, and quality systems. While the microbial DS is already commissioned, the mammalian DS capabilities designed on industry-leading Single Use Bioreactor (SUB) systems will be available to partners later this month (September 2022).

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise. Earlier in June 2022, the facility received European Union Good Manufacturing Practice (EU-GMP) approval.

Stelis continues to build its clientele with global partnerships and onboarding of new programs on the drug substance and drug product side. It remains a strong biologics CDMO player given its comprehensive capabilities, high-quality systems, and a large commercial scale with over 48,000 L of drug substance across modalities and over 400 million units of fill-finish capacity.