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COLOGNE, GermanyŚCEVEC Pharmaceuticals, the developer of a novel human expression system derived from amniocytes, and Aragen Bioscience Inc., a California- based contract research and development organization, have signed a strategic license agreement that will enable Aragen to offer its clients custom recombinant human cell lines expressing biotherapeutic proteins and antibodies as well as the transient and stable production of preclinical and clinical grade material.
The transient CAP-T protein production technology is based on CAP cells, an immortalized cell line for stable protein production developed by CEVEC. These non-tumor origin cell lines exhibit high protein expression, have been adapted to serum-free suspension culture and show post-translational modifications that are human-like, including authentic human glycosylation patterns.
"Both cell lines are derived from amniocytes, and therefore offer human like protein/antibody expression (better glycosylation and sialysation patterns)," says Wolfgang Kintzel, CCO of CEVEC. "The handling and performance with complex proteins of our stable expressing line (CAP) is superior to per-C6 from Crucell/DSM, and the transient cell line offers superior expression rates and protein quality than HEK293 freestyle. It outperforms HEK indeed by up to 40-fold higher expression rates."
Customers can use both systems (transient for research, stable for production) without having the need to switch the cell system, he adds, which is a major advantage for pharma customers.
Stable expression describes the production of recombinant proteins due to integration of the respective gene expression cassette into the chromosome of the producer cell line. In most cases, the gene of interest is integrated into the chromosome via non-homologous recombination in varying copy numbers. Transient expression stands for the temporary expression of a protein. For many applications, e.g., drug discovery, high-throughput screening, assay development or early-stage, preclinical drug development, transient expression offers the advantages of achieving both fast process times and high yields. It is usually achieved by simply transfecting the gene of interest as circular plasmid into the respective producer cells.
The collaboration couples CEVEC's novel and proprietary expression systems and cell lines with Aragen Bioscience's broad experience in cell line and process development to provide biotechnology and biopharmaceutical companies worldwide the opportunity to quickly obtain high-quality, preclinical and clinical-grade product generated from stable as well as transiently transfected cell lines.
"Our human amniocyte derived cells offer significant advantages when it comes to complex protein production, and we're pleased that Aragen has chosen our technology as a valuable addition to their existing service offerings. The signing of this contract also underlines the growing recognition our technology is receiving in the life sciences arena," Kintzel states.
Aragen Bioscience, located in Morgan Hill, Calif., specializes in recombinant cell line and hybridoma development, cell culture and protein purification process development and protein production, primary and immortalized cell-based assays, in vivo models of human disease and custom immunological services. According to CEO Rick Srigley, providing opportunities for companies developing products suitable for production in human cells is very important, including emerging and virtual companies that don't have the infrastructure internally.
"We believe that human cells will be a superior production system for a variety of complex proteins," he says, some of which are by their nature difficult to express. "CEVEC's technology is a valuable addition to our existing expression portfolio and will enable our customers to pursue new directions for proteins that were difficult to express in the past or did not show satisfactory posttranslational modifications."
From a commercial standpoint, he notes, the partnership with CEVEC will allow Aragen to provide a new service to its clients and expand its base as they access technology that would otherwise be unattainable.
CEVEC Pharmaceuticals GmbH was founded in 2004 by a group of scientists and clinicians from the University of Cologne. Based on their experience and their longstanding collaborative work, they had perceived a lack of innovative expression systems for more efficient production of biologics such as recombinant proteins or gene therapy vectors. CEVEC's novel proprietary human CAP and CAP-T expression systems are designed for manufacturing complex biopharmaceutical molecules with human glycosylation patterns. CEVEC actively started to out-license its technologies worldwide in 2005 and now supports CROs, CMOs, biotechs and pharmaceutical companies worldwide.