COLOGNE, Germany & FREIBURG, Germany--(BUSINESS WIRE)--CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, and CellGenix GmbH, a leading manufacturer of premium-grade reagents for clinical cell culture needs, today announced a collaboration and license agreement for the development and GMP production of selected cytokines for ex vivo cell culture therapy applications using CEVEC's proprietary CAP(R)Go technology. Financial details of this agreement were not disclosed.
Under the terms of the agreement, CEVEC offers its expertise regarding the development of selected CAP(R)Go cell lines as well as its competence for the expression of a variety of difficult to produce recombinant cytokines. In addition the company will grant CellGenix a license for the production and commercialization of CAP(R)Go-derived growth and differentiation factors.
CellGenix will provide its long-standing expertise in development of high-quality recombinant ex vivo reagents. In addition the company will use its in-house GMP manufacturing capabilities, established QA (Quality Assurance) system as well as its expert regulatory know-how to ensure compliance of CAP(R)Go-derived products with the complex regulatory landscape for cell-based therapies. The products will be marketed by CellGenix and expand the existing portfolio of GMP-grade cell culture systems to develop preclinical and clinical cell therapies.
"This agreement with CellGenix is a next step with respect to the further development of our technology in new application areas," commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH. "We additionally position our platform as the technology of choice to express certain cytokines in the growing field of ex vivo cell culture therapies. This is an additional endorsement of our unique human expression system."
"Through CEVEC's CAP(R)Go technology, CellGenix has access to new cytokines and other proteins which require human post-translational modification, like glycosylation, and which are therefore not accessible by bacterial expression," says Prof. Dr. Felicia Rosenthal, Chief Executive Officer of CellGenix GmbH. "The traceability to the completely characterized and documented parental CAP(R) Master Cell Bank (MCB) allows to maintain CellGenix' high safety standards also for future CAP(R)Go-derived, xeno-free products."
CellGenix is a leading manufacturer of premium-grade reagents for clinical cell culture needs. The company has more than 20 years in-house expertise in GMP manufacturing and development of products in the field of cell therapy, gene therapy and regenerative medicine. As trusted supplier CellGenix offers a comprehensive product portfolio, like preclinical and GMP-grade cytokines and serum-free media for cell and gene therapy applications. The products combine a maximum of quality and safety with excellent performance due to the state-of-the-art production, stringent in-house quality assurance and comprehensive documentation packages. All these factors help to simplify qualification and validation for manufacturing and market authorization and ensure the seamless transition from research to commercialization.
Privately held CEVEC, based in Cologne, Germany, is an expert for the production of tailor-made recombinant glyco-proteins and gene therapy vectors. The Company's core technologies, CAP(R)Go and CAP(R)GT are based on a unique human cellular expression system.
The CAP(R)Go expression platform comprises a portfolio of glyco-optimized human suspension cell lines for tailor-made glycosylation of recombinant proteins. The cells are highly efficient for the production of a broad range of difficult to express glyco-proteins and provide authentic human post-translational modifications. CAP(R)Go has proven to enhance the activity, stability and serum half-life of several candidate proteins.
The CAP(R)GT expression platform provides a fully scalable, regulatory endorsed production system for gene therapy vectors. CAP(R)GT cells grow to high cell densities and show a broad viral propagation spectrum including lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV). Furthermore, CAP(R)GT enables easier scale-up and reduced production costs when compared to adherent cell culture systems.
Research collaborations with international pharmaceutical and biotechnology partners followed by licensing agreements for the technology form one revenue base for CEVEC. In addition, the Company provides contract manufacturing for the GMP production in CAP(R)Go and CAP(R)GT cells.