Menarini Biotech partners with ERBC on clinical trials

Menarini Biotech, a group company of Italy’s Menarini, has entered into a strategic collaboration with ERBC, a leading pre-clinical contract research organization (CRO), aimed at streamlining and speeding up 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 entry barriers for early-stage innovation by offering a continuum from pre-clinical 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 GMP1), support in pre-clinical and clinical studies, delivery of regulatory-ready data through CMC (3) and safety (4) modules which can accelerate a smooth investigational 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.