ERBC , a leading preclinical contract research organization ( CRO ), and Menarini Biotech , a Menarini Group company providing custom development and manufacturing (CDMO) services and specializing in the development and manufacturing of biopharmaceuticals, announce a strategic partnership aimed at streamlining and accelerating the transition of biopharmaceuticals from research to First Clinical Trials ( FIH ).
The partnership between ERBC and Menarini Biotech aims to lower the barriers to entry for early-stage innovations by offering a continuum from preclinical development to Chemistry, Manufacturing and Control (CMC), which includes efficient and cost-effective development strategies for biopharmaceutical products, the timely delivery of such molecules in the required quality (GLP and/or GMP 1 ), support in preclinical and clinical studies, the provision of regulatory-compliant data through CMC (3) and safety modules (4) that can expedite a smooth submission of Initial New Drug (IND) applications, and expert advice in addressing 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.
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“The biggest challenge for early-stage biopharmaceutical projects is navigating the complex regulatory and manufacturing landscape to enable a rapid transition from discovery to delivery (technology transfer),” commented Nicola Torre , Managing Director of Menarini Biotech. “We are partners in innovation. With this collaboration, we offer a structured, efficient, and cost-effective approach to supporting the next generation of biopharmaceutical innovations by bridging the gap between cutting-edge research and the manufacturing of scalable, sustainable products.”
Given the inherent risk in biotechnology development, timing is often a critical success factor for clinical validation. By combining ERBC‘s expertise in conducting nonclinical studies for biotechnology drug candidates, including safety (toxicology), pharmacokinetics (PK), pharmacodynamics (PD), and analytics, with Menarini Biotech‘s robust CMC capabilities, this partnership provides comprehensive support for regulatory submissions and can help accelerate the development phase of biologics.
SOURCE: PRNewswire