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• The French National Agency for the Safety of Health Products (ANSM) granted a Pharmaceutical Establishment license on November 9th 2022, enabling the Le Mans site to offer enhanced quality control services for Antibody Drug Conjugate (ADC) drug products.
• This license is an important milestone for the Le Mans site, continuing its strong growth in the field of ADCs.
• It underlines Axplora’s commitment to help simplify customers’ drug supply chains.
Raubling – Axplora announces that a Pharmaceutical Establishment License has been granted for its Le Mans site in France. A multidisciplinary team – Quality Assurance, Quality Control, Regulatory Affairs, Technical Services – worked on the preparation and the submission of the application to the ANSM.
This is a key milestone in further enhancing Axplora’s ADC (Antibody-Drug Conjugate) technology platform offering. Le Mans has started providing analytical services for customers enabling the release of ADC drug products, streamlining supply chains and reducing their analytical burden by eliminating the need to qualify an additional provider of analytical services for the drug product.
"The Pharmaceutical Establishment License gives us a broader dimension and additional responsibilities in drug development, while continuing to guarantee the quality of our ADC medicines. This also echoes our Pharma focus, with a strengthened approach that encompasses the quality of our products and their pharmaceutical form, the process guiding their release, and a real awareness of the benefit to patients”, says Claire Gouverith, Global Head of Quality Assurance for Axplora.
"I am very proud of Axplora’s team of experts who made this success possible within a short period of time, in line with our growth dynamic. With this new service, we have responded to our customers’ aspirations to speed up their development projects with a simpler and more cost-effective supply chain", adds Rachel De Luca, Le Mans Site Director. "Our commitment remains the same: to deliver high quality services for ADCs, from payload and bioconjugation to the ADC drug product from early development phases to commercial supply.”
Axplora’s Le Mans site is a recognized leader in the supply of development & manufacturing services for ADCs. With over 15 years of experience & more than 200 cGMP clinical and commercial batches manufactured, the site is recognized for its expertise in both ADC payloads and bioconjugation. The site is proud to partner in the manufacture of 3 of 13 commercially approved ADCs today.