The company said the license is an important milestone for the facility, which is located in northwestern France, continuing its “strong growth” in the field of antibody drug conjugates (ADCs).
The site, which has expertise in ADC payloads and bioconjugation, has started providing analytical services for customers enabling the release of ADC drug products, which is aimed at streamlining supply chains, and reducing their analytical burden by eliminating the need to qualify an additional provider of analytical services for the drug product.
A multidisciplinary team including experts in quality assurance, quality control, regulatory affairs, and technical services worked on the preparation and the submission of the application to the ANSM.
"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,” said Claire Gouverith, global head of quality assurance for Axplora.
Rachel De Luca, Le Mans site director, said: "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.”
Following the merger of French contract development and manufacturing organization (CDMO), Novasep, and German API maker, PharmaZell, in April this year, all brands of the two companies, including those of PharmaZell’s group unit Farmabios, are consolidated under a newly created corporate umbrella called Axplora.
Sylke Hassel was named CEO of Axplora; the group counts as assets nine manufacturing facilities in Europe and India as well as a research center in the US.