ERBC, a leading preclinical Contract Research Organization (CRO), and Menarini Biotech, a company of the Menarini Group providing services as a Contract Development and Manufacturing Organization (CDMO) specialized in the development and manufacturing of biopharmaceuticals, today announce a strategic partnership aimed at streamlining and accelerating the transition of biopharmaceuticals from the research stage to First-in-Human (FIH) clinical trials.
The partnership between ERBC and Menarini Biotech aims to lower the barriers to early-stage innovation by offering a continuum from preclinical development to Chemistry, Manufacturing, and Controls (CMC), which includes efficient and cost-effective development strategies for biopharmaceutical products, the timely delivery of such molecules with the required quality (GLP and/or GMP1), support for preclinical and clinical studies, the provision of regulatory-compliant data through CMC (3) and safety modules (4) that can accelerate the smooth submission of Investigational New Drug (IND) applications, as well as expert advice in navigating the complex regulatory requirements for biopharmaceutical development.
Menarini Biotech also offers early integration of manufacturability and scalability through platform-based manufacturing processes and scalable systems, as well as tailored support for scale-up and production.
