Stelis Biopharma Partners with Merck
Stelis Biopharma, a fully-integrated biopharmaceutical company with capabilities in providing global contract development and manufacturing services, and Merck a premier supplier of solutions and services to the global life science industry, today announced the opening of its Joint Process Scale-Up Lab at the Stelis Biopharma R&D facility in Bengaluru. The lab, which was built as a centre of excellence for bioprocess scale-up and manufacturing services, represents the strength of the two groups.
This collaboration brings together Stelis’ end-to-end capabilities in high-yield biopharmaceutical process development from cell line to commercial manufacturing scale with Merck’s leading technological expertise in bioprocessing. Through the collaboration this Joint Process Scale-Up Lab and the forthcoming cGMP manufacturing facility in Bangalore will be equipped with Merck’s portfolio of Mobius® bioprocessing equipment. Stelis chose Merck for its best-in-class single-use manufacturing components for flexible operations and better regulatory compliance. Merck will bring its process know-how and application knowledge from global experts to help establish the single-use platform technologies at Stelis.
The Joint Process Scale-Up Lab bridges R&D and commercial manufacturing scales of biological API (Active Pharmaceutical Ingredient) by offering customers a seamless and robust transfer of optimized processes from small-scale R&D (Research & Development) lab to the large-scale commercial manufacturing site.
Commenting on the development, Joe Thomas, CEO, Stelis Biopharma said, “In the biopharma space, where the process is the product, our Process Scale-Up Lab fulfills a critical need by offering clients a reliable process bridge between R&D and commercial scales.”
He added, “After significant investments by Stelis in high-quality R&D and commercial-scale bio-manufacturing infrastructure in Bengaluru, the collaboration with Merck completes the value proposition for CDMO customers by offering an end-to-end solution from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply.”
Commenting on the Stelis announcement, Udit Batra, Member of the Merck Executive Board and CEO, Life Science, said, “Both Merck and Stelis bring leading technological expertise and an extensive bioprocess development and manufacturing portfolio that will help our customers accelerate development of biopharmaceuticals for clinical trials and manufacturing with greater reliability and cost effectiveness. This collaboration reinforces Merck’s position as the premier supplier of all process development and clinical stage manufacturing solutions, materials and services needed for biologics production.”
About Stelis Biopharma
Stelis Biopharma Private Limited (Stelis) is a vertically integrated biopharmaceutical company with R&D, process scale-up and end-to-end manufacturing capabilities from drug substance to finished drug products in all injectable formats. Stelis has a 30,000 square feet state of the art research facility in Bengaluru along with a soon-to-be commissioned 200,000 square feet integrated bio-manufacturing facility catering to biologic APIs and aseptically filled injectables conforming to international standards. The principal shareholders of Stelis are Strides Pharma (25+ years’ experience in high-quality generics for global markets), Tenshi Life Sciences Private Limited, (Integrated Life Sciences Company) and GMS Holdings (Group of diversified business and assets with a strong biopharma franchise in the MENA region).
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
Disclaimer: Certain statements in this release about future growth prospects are forward-looking statements and are subject to several risks, uncertainties and assumptions that could cause current stance to differ materially from those contemplated in such forward-looking statements. The company, its directors or the affiliates do have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition.