STRASBOURG, France & ROCKVILLE, Md.--(BUSINESS WIRE)--Transgene SA (Euronext: TNG) a company specializing in immunotherapies, and ABL, Inc., a contract research and manufacturing organization, today announced the purchase by ABL Europe, a wholly owned subsidiary of ABL, of Transgene's production asset situated in Illkirch, near Strasbourg. Transgene, ABL, Inc. and ABL Europe are all three members of the Institut Mérieux.
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 Establishment, a mandatory step to begin operations at the site. Manufacturing and other services will be provided under E.U. and U.S. GMP.
An addition to ABL's bioproduction capabilities
This acquisition provides ABL with an European bioproduction facility meeting the most stringent quality standards, which will allow it to serve the European CMO market, in addition to its already well established position in that field in the U.S. With its Rockville (MD) production unit and its new site in Illkirch, France, ABL will be a premier global CMO in the field, with the ability to significantly increase international client responsiveness and schedule flexibility.
Finalization of Transgene's industrial strategy
The sale by Transgene of its production asset was the last step of the company's reorganization initiated in June 2015. Indeed, 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.
Thomas VanCott, Ph.D., President and CEO of ABL, Inc. commented: "We have seen a consistent increase in demand for the production of virus-based products in recent years. 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 CEO of Transgene declared: "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."
About ABL, Inc. and ABL Europe
Part of Institut Mérieux, ABL, Inc. is a global contract research and manufacturing biomedical organization dedicated to advancing vaccines, therapeutics, other biologic products. ABL has extensive experience working with diverse organizations, including biopharmaceutical companies, non-profits, the U.S. Government, and academic entities. Notable contract manufacturing services include process and assay development, biologics cGMP manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC analytics. ABL also maintains immunological and molecular laboratories to support preclinical and GCLP clinical sample processing and testing. ABL has sites in both US and Europe (Lyon, France) to support its immune-biological testing.
For more information on ABL and our services, please visit our website at www.ablinc.com.
Transgene S.A. (Euronext: TNG), part of Mérieux Institute, is a publicly traded French biopharmaceutical company focused on discovering and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company's two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The Company has several other programs in clinical and pre-clinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. Additional information about Transgene is available atwww.transgene.fr.
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