Stelis Biopharma Limited (Stelis) is a fully integrated pure-play biologics Contract Development and Manufacturing Organization (CDMO), offering the complete spectrum of services, from cell line technology transfer to clinical and commercial manufacturing with capabilities to convert drug substance into stable formulations and fill and finish formats. With proven technical expertise in microbial, mammalian, viral vectors, and various other technology platforms with world-class cGMP manufacturing facilities that offer high-quality services for your global programs.
Stelis has three state-of-the-art facilities, with ~85,000 sqm of area house process development laboratories, scale-up, and manufacturing areas for mammalian, microbial and other modalities. The company’s highly automated facilities provide global services for products based on Monoclonal antibodies, Fusion proteins, Conjugation factors, Vaccines, Cell-free protein expression platforms, DNA adjuvants/plasmids, RNA products, Cell and gene therapy, and all other types of biologics, biosimilars and vaccines. It’s agility in building capacities, increasing accuracy, efficiency and speed at every stage of process development and manufacturing processes is unparalleled.
Stelis, over the years, has built a robust CDMO platform. Offers large drug substance capacities of over 48,000L across various modalities and drug product capacities exceeding 400 million units per annum. The company has the capabilities to deliver your projects from clinical to commercialization with best-in-class facilities capable of delivering any scale of production volumes with agility to expand capacities at industry-leading speed. With 48,000L of drug substance capacities across multiple modalities, Stelis is one of the largest CDMOs in the Asia-Pacific (APAC) region.
The company’s experienced quality and regulatory personnel help meet the highest global quality standards, ensure compliance and guide it’s clients through the regulatory approval. The large-scale commercial use facilities were designed with consultation from international regulatory agencies, including the USFDA, and a holistic and systematic approach to building and sustaining the Stelis Quality Culture.
For more information, visit www.stelis.com.