Tanvex CDMO Information

Founded in 2011, Tanvex BioPharma USA has been perfecting our skills in making biologic therapeutics more accessible to patients. To-date, we have successfully brought our first product to approval and two additional BLAs pending FDA approval. Our journey is defined by an unwavering commitment to excellence, innovation, and a passion for revolutionizing healthcare. We are now offering our technical and operational expertise to a greater audience by becoming a Contract Development and Manufacturing Organization – Tanvex CDMO. Nestled in the Sorrento Valley of San Diego, our 100,000 square feet, state-of-the-art campus serves as the nucleus of our operations. With Research and Development, and GMP manufacturing all under one roof, we foster smooth collaboration, maximizing efficiency at every step of the drug development process from pre-clinical to commercialization for both microbial and mammalian derived biologics. At the heart of Tanvex CDMO is our dedicated team of over 160 skilled professionals who bring unparalleled expertise to every project. Innovation thrives at Tanvex CDMO where we offer a comprehensive suite of services including: ● Cell line development (mammalian and microbial) ● Microbial fermentation process development and optimization ● Mammalian cell culture process development and optimization ● Pre-formulation and drug product formulation development ● Analytical development, method qualification/validation ● QC lot release testing & Stability study ● Clinical to Commercial GMP manufacturing (mammalian and microbial) ● Regulatory support From high-throughput (HT) workflows for process development to streamlined equipment for seamless process transfer to GMP production, coupled with single-use technology in our GMP manufacturing facilities, we are ready to advance your molecule to the next stage. Together, let's deliver groundbreaking advancements in biopharmaceuticals and make a lasting impact on healthcare worldwide.