ERBC, a France-based preclinical contract research organisation (CRO), announced on Thursday that it has formed a strategic partnership with Italy-based Menarini Biotech, a Menarini Group company.
The companies say that the collaboration is aimed at streamlining and accelerating the transition of biopharmaceuticals from the research stage to First-In-Human (FIH) clinical trials.
The partnership is intended to lower entry barriers for 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 biopharmaceuticals, delivery of such molecules on time, and of the required level of quality (GLP and/or GMP, support in preclinical and clinical studies, delivery of regulatory-ready data through CMC and safety modules which can accelerate a smooth Initial New Drug (IND) submission, as well as expert guidance in navigating the complexities of regulatory requirements for the development of biopharmaceuticals.
Menarini Biotech also provides an early integration of manufacturability and scalability through platform-based manufacturing processes and scalable systems as well as tailored support for scale-up and production.
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