ERBC & Menarini Biotech Partner to Advance Biopharma to Human Trials

ERBC, a leading preclinical contract research organization (CRO), and Menarini Biotech, a Menarini Group company, offering services as a custom development and manufacturing organization (CDMO), specialized in the development and manufacture of biopharmaceuticals, announce today a strategic partnership 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 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 GMP1), 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.

""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 (technology transfer),"" commented Nicola Torre, General Manager Menarini Biotech. ""We are partners in innovation. With this collaboration, we are offering a structured, efficient, and cost-effective approach to support the next generation of biopharmaceutical innovation by bridging the gap between cutting-edge science and the manufacture of scalable, sustainable products.""

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.

""Through this partnership, we are providing biopharmaceutical companies, biotech startups, and academic teams the essential tools and expertise needed to transition from breakthrough research to clinical development at the right quality level,"" 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 novel therapies to patients much faster.""

About Menarini Biotech:
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

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 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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!