ERBC & Menarini Biotech Partner to Fast-Track Biopharma Development

Strategic partnership representing a turnkey solution for biopharmaceutical companies seeking an integrated path to accelerate early-stage development
Non-clinical study expertise combined with proven chemistry, manufacturing and controls capabilities enables a comprehensive approach to facilitate the transition from research to first-in-human clinical trials
BAUGY, France and POMEZIA, Italy , April 4, 2025 /PRNewswire/ -- ERBC , a leading preclinical Contract Research Organization ( CRO ), and Menarini Biotech , a Menarini Group company offering services as a CDMO , today announced a strategic partnership to streamline and accelerate the transition of biopharmaceutical products from research to first-in-human clinical trials.

The partnership between ERBC and Menarini Biotech aims to lower barriers to entry for early-stage innovation by providing a continuum from preclinical development to chemistry, manufacturing and controls (CMC) that includes efficient and cost-effective development strategies for biopharmaceuticals, delivery of these molecules on time, and at the required quality level (GLP and/or GMP 1 ), support for preclinical and clinical studies, provision of regulatory-ready data through CMC (3) and safety (4) modules that can expedite the submission of an Initial New Drug Application (IND), as well as expert guidance to navigate the complexities of regulatory requirements for biopharmaceutical development.

Menarini Biotech also ensures early integration of manufacturability and scalability through platform-based manufacturing processes and scalable systems, as well as tailored support for scale-up and production.

“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. Through this collaboration, we offer a structured, efficient, and cost-effective approach to support the next generation of biopharmaceutical innovations by bridging the gap between cutting-edge science and the manufacturing of scalable, sustainable products.”

Given the inherent risk in biotechnology development, timeliness is often a critical success factor in achieving clinical validation. By combining ERBC's expertise in conducting non-clinical studies for biotechnology drug candidates, including safety (toxicology), pharmacokinetics (PK), pharmacodynamics (PD), and analytics, with Menarini Biotech's strong CMC capabilities, this partnership provides comprehensive support for regulatory processes and can help accelerate the development phase of biopharmaceutical products.

“Through this partnership, we are providing biopharmaceutical companies, biotech startups, and academic teams with the tools and expertise needed to move from cutting-edge research to clinical development at the right level of quality,” said Christophe Priou , CEO of ERBC. “By combining our preclinical expertise with Menarini Biotech’s proven CMC capabilities, we are eliminating bottlenecks and helping innovators bring new treatments to patients much faster.”

About Menarini Biotech:

Menarini Biotech is a fast-growing, fully integrated CDMO for biopharmaceuticals located in the Rome region of Italy. Founded in 2003, Menarini Biotech's mission is to provide biopharmaceutical companies with high-quality services, from clinical development to GMP manufacturing up to BSL-2, in a state-of-the-art single-use facility. Services offered by Menarini Biotech include CHO cell line development and analytical development in the context of standard and non-standard mAbs and new molecular formats. For more information, visit www.menarini-biotech.com

About ERBC:

ERBC is a leading preclinical CRO specializing in safety assessment—including safety pharmacology, genetic toxicology, in vitro and in silico toxicology , general toxicology, juvenile toxicology, and reproductive and developmental toxicology—as well as pharmacokinetics, bioanalytics, and translational research. With a strong commitment to scientific excellence and regulatory compliance, ERBC partners with pharmaceutical, biotechnology, chemical, and medical device companies to de-risk their development programs and advance human health.

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