ERBC and Menarini Biotech Partner to Accelerate First-in-Human Trials

• ERBC and Menarini Biotech have announced a strategic partnership to streamline the development of biopharmaceuticals from research to First-In-Human (FIH) trials.

• The collaboration integrates preclinical research and Chemistry, Manufacturing, and Controls (CMC) services to support regulatory submissions and accelerate early-stage innovation.

ERBC, a preclinical contract research organisation (CRO), and Menarini Biotech, a contract manufacturing organisation (CDMO) within the Menarini Group, have entered a strategic partnership to support biopharmaceutical companies through the transition from early research to First-In-Human (FIH) clinical trials.

Announced today, the collaboration aims to provide a seamless development pathway by combining ERBC’s capabilities in non-clinical studies—including toxicology, pharmacokinetics, and pharmacodynamics—with Menarini Biotech’s Chemistry, Manufacturing, and Controls (CMC) services. This integrated approach is designed to support regulatory submissions and reduce the time to clinical validation.

The two companies will offer early-stage innovators access to a continuum of services that include scalable manufacturing processes, regulatory-ready data packages, and expert guidance to meet GLP and GMP standards. The partnership specifically addresses challenges in manufacturability, scalability, and regulatory complexity, offering tailored support for smooth technology transfer.

“The greatest challenge for early-stage biopharmaceuticals projects is navigating the complex regulatory and manufacturing landscape to allow a rapid transition from discovery to delivery,” said Nicola Torre, General Manager, Menarini Biotech.

By combining complementary expertise, the partnership targets biotech startups, academic institutions, and emerging biopharma firms looking for cost-effective, structured support to advance novel therapies to clinical development.