COLOGNE, Germany—CEVEC Pharmaceuticals, the developer of anovel human expression system derived from amniocytes, and Aragen BioscienceInc., a California- based contract research and development organization, havesigned a strategic license agreement that will enable Aragen to offer itsclients custom recombinant human cell lines expressing biotherapeutic proteinsand antibodies as well as the transient and stable production of preclinicaland clinical grade material.
The transient CAP-T protein production technology is basedon CAP cells, an immortalized cell line for stable protein production developedby CEVEC. These non-tumor origin cell lines exhibit high protein expression,have been adapted to serum-free suspension culture and show post-translationalmodifications that are human-like, including authentic human glycosylationpatterns.
"Both cell lines are derived from amniocytes, and thereforeoffer human like protein/antibody expression (better glycosylation andsialysation patterns)," says Wolfgang Kintzel, CCO of CEVEC. "The handling andperformance with complex proteins of our stable expressing line (CAP) issuperior to per-C6 from Crucell/DSM, and the transient cell line offerssuperior expression rates and protein quality than HEK293 freestyle. Itoutperforms 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, headds, which is a major advantage for pharma customers.
Stable expression describes the production of recombinantproteins due to integration of the respective gene expression cassette into thechromosome of the producer cell line. In most cases, the gene of interest isintegrated into the chromosome via non-homologous recombination in varying copynumbers. Transient expression stands for the temporary expression of a protein.For many applications, e.g., drug discovery, high-throughput screening, assaydevelopment or early-stage, preclinical drug development, transient expressionoffers the advantages of achieving both fast process times and high yields. Itis usually achieved by simply transfecting the gene of interest as circularplasmid into the respective producer cells.
The collaboration couples CEVEC's novel and proprietaryexpression systems and cell lines with Aragen Bioscience's broad experience incell line and process development to provide biotechnology andbiopharmaceutical companies worldwide the opportunity to quickly obtainhigh-quality, preclinical and clinical-grade product generated from stable aswell as transiently transfected cell lines.
"Our human amniocyte derived cells offer significantadvantages when it comes to complex protein production, and we're pleased thatAragen has chosen our technology as a valuable addition to their existingservice offerings. The signing of this contract also underlines the growingrecognition our technology is receiving in the life sciences arena," Kintzelstates.
Aragen Bioscience, located in Morgan Hill, Calif.,specializes in recombinant cell line and hybridoma development, cell cultureand protein purification process development and protein production, primaryand immortalized cell-based assays, in vivomodels of human disease and custom immunological services. According to CEORick Srigley, providing opportunities for companies developing productssuitable for production in human cells is very important, including emergingand virtual companies that don't have the infrastructure internally.
"We believe that human cells will be a superior productionsystem for a variety of complex proteins," he says, some of which are by theirnature difficult to express. "CEVEC's technology is a valuable addition to ourexisting expression portfolio and will enable our customers to pursue newdirections for proteins that were difficult to express in the past or did notshow satisfactory posttranslational modifications."
From a commercial standpoint, he notes, the partnership withCEVEC will allow Aragen to provide a new service to its clients and expand itsbase as they access technology that would otherwise be unattainable.
CEVEC Pharmaceuticals GmbH was founded in 2004 by a group ofscientists and clinicians from the University of Cologne. Based on theirexperience and their longstanding collaborative work, they had perceived a lackof innovative expression systems for more efficient production of biologicssuch as recombinant proteins or gene therapy vectors. CEVEC's novel proprietaryhuman CAP and CAP-T expression systems are designed for manufacturing complexbiopharmaceutical molecules with human glycosylation patterns. CEVEC activelystarted to out-license its technologies worldwide in 2005 and now supportsCROs, CMOs, biotechs and pharmaceutical companies worldwide.