The production asset is designed and equipped to manufacture clinical lots of biophamaceuticals and vaccines using viral vectors.
ABL Europe has just received authorization by the French Agence Nationale de Sécurité du Médicament to operate a pharmaceutical Eestablishment, a mandatory step to begin operations at the site. Manufacturing and other services will be provided under EU and U.S. GMP guidelines.
This acquisition provides ABL with a European bioproduction facility meeting the most stringent quality standards, which will allow it to serve the European CMO market, in addition to its already established position in that field in the U.S. With its Rockville, MD production unit and its new site in Illkirch, ABL has its sites on being a premier global CMO in the field, with the ability to increase international client responsiveness and schedule flexibility.
The sale by Transgene of its production asset was the last step of the company’s reorganization initiated in June 2015. Part of the reorganization plan was the outsourcing of the manufacturing of clinical lots and focusing on the company’s core expertise, the immuno-engineering of viral vectors and clinical developments.
In parallel to this transaction, Transgene and ABL Europe have signed a three-year agreement under which Transgene has secured the production of the necessary clinical lots for its clinical development plan.
“We have seen a consistent increase in demand for the production of virus-based products in recent years,” said Thomas VanCott, president and chief executive officer, ABL, Inc. “Innovators from industry and the public sector require partners that can provide diverse and high level skill sets for the development of vaccines against emerging diseases, and gene and immunotherapies. Production in compliance with pharmaceutical-grade quality is essential to advance these products from the laboratory to scalable, GMP-compliant production for clinical and commercial supply.”
Philippe Archinard, chairman and chief executive officer, Transgene, said, “We are delighted about crossing this final major step of our reorganization plan and the implementation of our new industrial strategy. We are selling a quality asset to a player we fully trust. Securing the procurement of our clinical lots for the next three years was a key element of the deployment of our clinical development plan. This new strategy for the production of our clinical lots and, later, commercial lots, leans now on two important actors: ABL Europe and Sanofi/Genzyme with whom we have signed an agreement in 2013. This organization will provide us financial flexibility while keeping reactivity in procurement as well as the quality of our products to be tested in Man.”