europeanpharmaceuticalreview July 31, 2019
Tag: Eurofins , Alphora , Amatsigroup , CDMO
In 2017, Eurofins Scientific (EUFI.PA), a world leader in biopharmaceutical testing acquired Alphora Research Inc. ("Alphora") and Amatsigroup SAS ("Amatsigroup") to support Eurofins’ extensive drug development platform. Starting July 2, 2019 the commercial brand for Eurofins Alphora and Eurofins Amatsigroup is now Eurofins CDMO (Contract Development Manufacturing Organization) falling under the CDMO umbrella in conjunction with Eurofins operations in North America and India. Eurofins CDMO provides integrated, end-to-end solutions for Pre-Clinical and Clinical outsourcing services of both Drug Substance/API and Drug Product manufacturing for biologics and small molecules.
Science represents the foundation of our business and Eurofins CDMO’s agility and customized support services allow us to:
Support clients to move rapidly through the drug development value chain
Perform complex formulation screening and development for sterile and non-sterile manufacturing
Accelerate process development and scale-up under GMP compliance
Supply clinical trial materials including packaging and logistics
Provide regulatory compliance throughout each stage of the development cycle.
About Eurofins Alphora
Eurofins Alphora provides API technology services for the scale-up of complex small molecules for pharmaceutical and biotechnology companies. The company provides flexible and sustainable solutions to support IND through to Commercial Readiness of APIs. Eurofins Alphora operates FDA and Health Canada inspected facilities including cGMP Plants, Organic Chemistry, PR&D, and Drug Product Development laboratories supported by Quality Control/Quality Assurance functions. A separate high-potency suite completes Alphora’s 74,000ft² facilities. A 3rd cGMP plant has recently come online to add additional capacity for an active pipeline of projects.
About Eurofins Amatsigroup
Eurofins Amatsigroup provides drug development services for biologics and small molecules. We are experts in breakthrough technologies for highly potent compounds, poorly soluble drugs, lyophilisation processes and specific therapeutic areas (immunotherapies, orphan drugs, paediatric dosage forms…). Our European facilities are perfectly designed for small batches either for sterile or non-sterile dosage forms. Involved in the earliest steps, our highly-qualified project management team proposes a complete drug development strategy in compliance with regulatory requirements (EMA, FDA, ANSM, ANSES, FAMHP, PMDA). Our goal is to build sustainable partnerships with our customers to support their drug development pathways.
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