Cologne, Germany and Baltimore, MD, USA, June 6th, 2016 – CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors and Paragon Bioservices, Inc., a leader in the manufacturing of biopharmaceuticals and vaccines, today announced that the companies signed a collaboration and license agreement to jointly establish CEVEC’s proprietary CAP(R) technologies as a new industry standard for the scalable production of viral gene therapy vectors in North America.
Under the terms of the agreement, CEVEC and Paragon will co-market CEVEC’s proprietary CAP(R) technologies-including both the CAP(R)GT expression system for gene therapy and CAP(R)Go for glycoproteins-as well as Paragon’s capabilities and expertise regarding CAP(R)-based research and development services in North America.
CEVEC will recommend that its licensees use Paragon as its preferred partner for CDMO services in North America. Additionally, CEVEC and Paragon will jointly develop and market scaled-up clinical production processes for AV (adenovirus), AAV (adeno associated virus) and LV (lentivirus)-based gene therapy vectors using the CAP(R)GT platform.
CEVEC will bring in its expertise regarding the evaluation and development of selected CAP(R) cell lines, including the development of viral packaging and producer cell lines. Paragon will provide CDMO services to CEVEC’s North American CAP(R) technology licensees, including manufacture of CAP(R)GT-derived materials for use in preclinical studies, as well as in phase I and phase II clinical trials.
Financial details of this agreement were not disclosed.
“This agreement is the next step in executing on our strategy and sets the stage to roll out our CAP(R) technologies into the North American markets. Paragon is a strong CDMO with a good track record,” commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH. “The combination of CEVEC’s expertise with its increasingly recognized proprietary CAP(R)GT and CAP(R)Go technologies and Paragon’s capabilities in high-quality biopharmaceutical process development and GMP production provides a timely solution for industrial needs in fast-growing markets, such as the larger-scale manufacture of viral vectors in gene therapy.”
“At Paragon, we are always looking for new and innovative technologies that provide clear competitive advantages and add significant value to our service portfolio in the best interest of our customers,” said Peter Buzy, President of Paragon Bioservices, Inc. “We are excited at the potential of expanding our breadth and depth of expertise and capabilities with recombinant viral vectors and glycoproteins to continue to advance transformative therapeutic approaches that can benefit from scalable and efficient CAP(R)-based processes.”