Stelis Biopharma

Stelis Biopharma is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) specializing in biologics and vaccines. The company offers end-to-end solutions across various modalities, including monoclonal antibodies, fusion proteins, conjugation factors, vaccines, cell-free protein expression platforms, DNA adjuvants/plasmids, RNA products, and cell and gene therapy. Stelis operates three state-of-the-art facilities in Bengaluru, India, spanning approximately 85,000 square meters of process development and manufacturing space. The company's capabilities include drug substance manufacturing with over 48,000 liters of capacity across multiple modalities and drug product manufacturing exceeding 400 million units annually. Stelis provides services for both clinical and commercial-scale production, with the ability to expand capacities rapidly. In June 2022, Stelis received EU-GMP certification for two of its manufacturing facilities from Hungary's National Institute of Pharmacy and Nutrition. The company's flagship facility (Unit 2) in Bengaluru is an integrated manufacturing setup leveraging microbial and mammalian platforms for biologics and biosimilars in various fill-finish formats. In September 2023, Strides Pharma Science, Stelis Biopharma's parent company, announced plans to spin off its oral soft gelatin contract manufacturing business into Stelis, creating a new entity called OneSource. This move aimed to build a specialty pharmaceutical CDMO with capabilities in biologics, oral soft gels, complex injectables, sterile injectables, and other complex drug delivery systems. The demerger was expected to be completed by April 2024, subject to regulatory approvals. As of September 2023, OneSource was projected to generate revenues between USD 140 million and USD 150 million in FY24, with an expected increase to USD 180-USD 200 million in FY25.

Key customers and partnerships

Stelis Biopharma has established partnerships with various pharmaceutical companies and organizations. In September 2022, the company received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) based on an on-site Pre-Approval Inspection. This was followed by the first product approval for one of its key customers in December 2022. In January 2023, Stelis received another EIR from the FDA for drug-device combination products to be commercialized at its Bengaluru facility. The company has also undergone inspections by the European Medicines Agency (EMA) and Australia's Therapeutic Goods Administration (TGA). Stelis has collaborated with Merck Life Sciences to set up a cGMP scale-up facility alongside its Process Development Laboratory. As of January 2023, the company reported having significant capacities established and customers onboarded, with several of its customers' key filings progressing toward approvals.