Salute e Benessere
ERBC and Menarini Biotech Join Forces to Accelerate the Development of Biopharmaceuticals from Research to First-in-Human Clinical Trials
The partnership between ERBC and Menarini Biotech aims 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 (3) and safety (4) 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.
commented Nicola Torre , General Manager Menarini Biotech.
Given the inherent risk in biotechnological development, timing is often a critical success factor in attaining clinical validation. By combining ERBC's expertise in the conduct of non-clinical studies for biotech 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 potentially help accelerate the development stage of biologics.
said
Christophe Priou , CEO of ERBC.
Menarini Biotech is a fast-growing, fully integrated CDMO for biologics located in the greater Rome area of Italy . Established in 2003, Menarini Biotech's mission is to provide world-class, high-quality services for biopharmaceutical companies from clinical development to GMP manufacturing up to BSL-2 in a state-of-the-art, fully single-use facility. The services Menarini Biotech can offer include CHO cell line development and analytical development in the context of standard and non-standard mAbs and new molecular formats. For further information please see www.menarini-biotech.com
ERBC is a leading preclinical CRO specializing in safety assessment—including safety pharmacology, genetic toxicology, and toxicology, general toxicology, juvenile and reproductive & developmental toxicology—along with pharmacokinetics, bio-analytics, and translational research. Committed to scientific excellence and regulatory compliance, ERBC partners with pharmaceutical, biotech, chemical, and medical device companies to de-risk their development programs and advance human health.
Good Laboratory Practices; Good Manufacturing Practices
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