- Agreement establishes Paragon as CEVEC’s preferred partner for contract development and manufacturing (CDMO) services in North America
- Companies will conduct coordinated marketing and business development activities to establish CEVEC’s CAP(R) technologies as a new standard for gene therapy vector production
- Collaboration includes developing a scalable clinical production process for AAV-based gene therapy vectors based on the CAP(R)GT platform
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.”
CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression System. CAP(R)GT is a regulatory endorsed expression platform for scalable viral vector production. CAP(R)GT suspension cells grow to high cell densities and show a broad viral propagation spectrum. Gene therapy vectors such as lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV) can be produced at industrial scale. CAP(R)GT enables better scale-up and competitive production costs when compared to adherent cell culture systems.
CAP(R)Go enables the production of proteins previously out of reach. The expression platform comprises a portfolio of glyco-optimized human suspension cell lines for tailor made glycosylation of recombinant proteins. The cells highly efficiently produce a broad range of difficult to express glycoproteins and provide authentic human post-translational modifications.
About Paragon Bioservices, Inc.:
Paragon Bioservices is a private-equity backed contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of biopharmaceuticals. The company provides research services, process development and cGMP manufacturing. Paragon functions as a translational bridge-from the research bench through manufacturing of APIs and finished drug product for Phase I/II clinical trials. Paragon’s aim is to build strong client partnerships for development and manufacturing, focusing on transformative technologies, including oncology immunotherapies (CAR-T cell therapies and oncolytic viruses), new generation vaccines (VLPs) and gene therapies (AAV). Paragon’s cGMP facilities include microbial and mammalian suites, aseptic fill-finish and fully-segregated virus facilities.
CEVEC Pharmaceuticals GmbH
Chief Executive Officer
T.:+49 221 46020800
Paragon Bioservices, Inc.
SVP Marketing & Commercial Strategy
T.: +1 (410) 975 4053