Sanofi Pasteur Accesses ProBioGen AG's AGE1.CR® Cell Lines for Various Pox-vectored Vaccine Products Under Development
Published: Feb 03, 2009
Under the research agreement, ProBioGen will optimize the production process for the specific vaccines. Furthermore, Sanofi is granted access to the extensively characterised Master Cell Bank and to initiate the GMP program. Originally, Sanofi Pasteur had obtained the cell lines under a feasibility agreement, which led to the generation of a comprehensive data package on ProBioGen’s AGE1.CR® cell lines. Sanofi Pasteur has also secured an option to enter into a non-exclusive commercial license agreement with industry-typical upfront and milestone payments and royalties. Financial details of the deal were not disclosed.
“This is a clear breakthrough for our proprietary AGE1.CR® technology that we have developed in cooperation with our partner IDT Biologics. Sanofi Pasteur, the recognized leader in the vaccines business, is interested in our platform technology after an in-depth evaluation,” stated Michael Schlenk, CEO at ProBioGen. “An outstanding productivity and an excellent safety profile combined with the broad applicability of the cell lines could make AGE1.CR® the new state-of-the-art technology. Moreover, the AGE1.CR® cell lines may be used for the manufacturing of clinical stage compounds very soon.”
About ProBioGen AG ProBioGen is a leading cell specialist. By combining deep molecular understanding of cells with state-of-the-art industry process engineering and production know-how, ProBioGen’s technologies enable biopharmaceutical companies to develop products with superior efficiency, safety and a more favourable cost profile. Since its inception in 1994, the company has processed more than 300 cell lines and established a GMP unit based on disposable reactor technology, which supports all currently available manufacturing processes. The company is headquartered in Berlin.
AGE1.CR® has been developed by ProBioGen in cooperation with IDT Biologika GmbH to replace embryonated chicken eggs and chicken embryonic fibroblasts as substrate for production of human and animal vaccines. The immortal cell line obviates dependence on external supply of pharmaceutical grade calf serum and SPF chicken and thus allows production of therapeutics and vaccines in closed systems. AGE1.CR® is derived from specific tissue of a single duck embryo without feeder cell layers. This cell line fully supports the production of a wide spectrum of wild-type and recombinant viruses, including highly attenuated poxviruses. In the AGE1.CR® cell line from muscovy duck no particle-associated retrovirus activity has been detected. The approach in generating the cell line is consistent with the “defined risk” guidelines issued by the FDA. Exhaustive analytical tests required for regulatory submission with US and European regulatory agencies have been performed. The resulting data package provides a strong background for application of AGE1.CR® as a producer cell line for biopharmaceuticals. For more information, please visit www.probiogen.de
Contact for ProBioGen:
Dr Gertraud Unterrainer, CFO Goethestrasse 54 13086 Berlin Tel.: +49 (0)30 924 006-0 Fax: +49 (0)30 924 006-19 email: firstname.lastname@example.org