ERBC and Menarini Biotech Unite to Accelerate Biopharmaceutical Development from Research to Clinical Trials
In a significant move to enhance the biopharmaceutical landscape, ERBC, a leading contract research organization (CRO), has announced a strategic partnership with Menarini Biotech, part of the Menarini Group. This collaboration is aimed at accelerating the development of biopharmaceutical products, targeting a seamless transition from preclinical research to the first phase of clinical trials.
The joint efforts focus on streamlining the pathway for biopharmaceutical innovations, breaking down barriers at the early stages of product development. This partnership is designed to provide a comprehensive solution that integrates expertise in non-clinical research with robust capabilities in chemistry, manufacturing, and controls (CMC), thereby offering efficient and cost-effective strategies for bio-drug development.
One of the primary objectives of this collaboration is to maintain continuity from preclinical development through CMC, ensuring that molecules are delivered with the required quality and in due time. This includes compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations, thus facilitating smoother regulatory submissions tied to drug development.
Nicola Torre, the General Manager of Menarini Biotech, emphasized the importance of this partnership in navigating the complex regulatory and manufacturing landscape that poses challenges for early-stage biopharmaceuticals. By joining forces, ERBC and Menarini Biotech can provide structured and efficient support for innovations in the next generation of biopharmaceuticals, bridging the gap between groundbreaking science and the scalable production of sustainable therapies.
The clinical validation process is often critical in the success of biotechnological product development, where time plays an integral role. By capitalizing on ERBC's expertise in non-clinical research—including safety (toxicology), pharmacokinetics (PK), pharmacodynamics (PD), and analytics—along with Menarini Biotech's solid CMC capabilities, this partnership is poised to offer comprehensive regulatory support and accelerate the development of biological products.
Christophe Priou, the CEO of ERBC, commented, "This partnership equips biopharmaceutical companies, biotech startups, and research teams with the necessary tools and expertise to transition from groundbreaking research to clinical stage while ensuring quality standards are met." He stressed that combining ERBC’s preclinical research knowledge with Menarini Biotech's proven CMC capabilities will eliminate hurdles and assist innovators in delivering novel therapies to patients in a much shorter timeframe.
About Menarini Biotech
Menarini Biotech is a rapidly growing, fully integrated CDMO (Contract Development and Manufacturing Organization) specializing in the production of biological products. Based in the metropolitan area of Rome, Menarini Biotech has been dedicated to providing high-quality services to biopharmaceutical companies since its establishment in 2003. Their services cover a wide range from clinical development to GMP-compliant production at BSL-2 levels, utilizing a state-of-the-art facility designed for the manufacture of single-use products. Their expertise includes the development of CHO cell lines and analytical development concerning standard and custom monoclonal antibodies and new molecular entities. More information is available at Menarini Biotech.
About ERBC
ERBC is a premier CRO specializing in preclinical research, particularly focusing on safety assessment, including safety pharmacology, genetic toxicology, in vitro and in silico toxicology, and general toxicology, alongside pharmacokinetic, bioanalytical, and translational research. By striving for scientific excellence and regulatory compliance, ERBC collaborates with pharmaceutical, biotechnology, chemical, and medical device companies to mitigate risks in their development programs and contribute positively to human health advancements.
In conclusion, the alliance between ERBC and Menarini Biotech marks a significant step toward enhancing the efficiency and effectiveness of biopharmaceutical development, promising a future where groundbreaking therapies can reach patients faster and more reliably.
The joint efforts focus on streamlining the pathway for biopharmaceutical innovations, breaking down barriers at the early stages of product development. This partnership is designed to provide a comprehensive solution that integrates expertise in non-clinical research with robust capabilities in chemistry, manufacturing, and controls (CMC), thereby offering efficient and cost-effective strategies for bio-drug development.
One of the primary objectives of this collaboration is to maintain continuity from preclinical development through CMC, ensuring that molecules are delivered with the required quality and in due time. This includes compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations, thus facilitating smoother regulatory submissions tied to drug development.
Nicola Torre, the General Manager of Menarini Biotech, emphasized the importance of this partnership in navigating the complex regulatory and manufacturing landscape that poses challenges for early-stage biopharmaceuticals. By joining forces, ERBC and Menarini Biotech can provide structured and efficient support for innovations in the next generation of biopharmaceuticals, bridging the gap between groundbreaking science and the scalable production of sustainable therapies.
The clinical validation process is often critical in the success of biotechnological product development, where time plays an integral role. By capitalizing on ERBC's expertise in non-clinical research—including safety (toxicology), pharmacokinetics (PK), pharmacodynamics (PD), and analytics—along with Menarini Biotech's solid CMC capabilities, this partnership is poised to offer comprehensive regulatory support and accelerate the development of biological products.
Christophe Priou, the CEO of ERBC, commented, "This partnership equips biopharmaceutical companies, biotech startups, and research teams with the necessary tools and expertise to transition from groundbreaking research to clinical stage while ensuring quality standards are met." He stressed that combining ERBC’s preclinical research knowledge with Menarini Biotech's proven CMC capabilities will eliminate hurdles and assist innovators in delivering novel therapies to patients in a much shorter timeframe.
About Menarini Biotech
Menarini Biotech is a rapidly growing, fully integrated CDMO (Contract Development and Manufacturing Organization) specializing in the production of biological products. Based in the metropolitan area of Rome, Menarini Biotech has been dedicated to providing high-quality services to biopharmaceutical companies since its establishment in 2003. Their services cover a wide range from clinical development to GMP-compliant production at BSL-2 levels, utilizing a state-of-the-art facility designed for the manufacture of single-use products. Their expertise includes the development of CHO cell lines and analytical development concerning standard and custom monoclonal antibodies and new molecular entities. More information is available at Menarini Biotech.
About ERBC
ERBC is a premier CRO specializing in preclinical research, particularly focusing on safety assessment, including safety pharmacology, genetic toxicology, in vitro and in silico toxicology, and general toxicology, alongside pharmacokinetic, bioanalytical, and translational research. By striving for scientific excellence and regulatory compliance, ERBC collaborates with pharmaceutical, biotechnology, chemical, and medical device companies to mitigate risks in their development programs and contribute positively to human health advancements.
In conclusion, the alliance between ERBC and Menarini Biotech marks a significant step toward enhancing the efficiency and effectiveness of biopharmaceutical development, promising a future where groundbreaking therapies can reach patients faster and more reliably.
Topics Health）
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