CEVEC and BioLamina combine technology leadership for commercial production of recombinant laminins for ex vivo cell therapies
- CEVEC adds laminins as CAP®Go application in the field of ex vivo cell culture products for cell therapies
- CEVEC’s CAP®Go to displace HEK293 and CHO cell lines in GMP manufacturing
- BioLamina to further grow its leading high quality ex vivo cell culture laminin product portfolio
- First commercial CAP®Go-derived laminin, LN-521, expected to be globally available in 2016
Cologne, Germany and Stockholm, Sweden, October 28th, 2015
CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, and BioLamina AB, a leading manufacturer of high quality products for primary cell culture, announced today a strategic collaboration for the commercial production of research grade and clinical grade laminins for ex vivo cell culture applications using CEVEC’s proprietary CAP®Go technology which is optimal for the production of these otherwise difficult to produce recombinant glycoproteins. Financial details of this agreement were not disclosed.
Under the terms of the agreement, CEVEC will provide its expertise in process development as well as its competence in GMP production, in collaboration with its joint venture partner GenIbet, of selected laminins based on the Company’s proprietary CAP®Go technology. This joined competence embraces cell line and process development, GMP cell banking and GMP production including fill & finish. CEVEC retains the rights to develop laminins for therapeutic use and grants BioLamina an exclusive license for the commercialization of CAP®Go based laminins patented by BioLamina for ex vivo cell culture therapies. The first laminin, Laminin-521, which is used to proliferate stem cells without causing genomic abnormalities, will be launched in 2016.
BioLamina focuses on research and development, to understand how laminins can be used to deplete technical problems associated in primary cell culture as well as on global sales and marketing of the commercially produced and finished products through its direct sales force and network of distributors. In this long-term strategic cooperation, BioLamina plans to initially add up to six new variants of laminins to its leading portfolio of recombinant laminins to enable cell culture of an accelerating range of human cell types with increased reliability and quality.
“The agreement with BioLamina is again an endorsement of our CAP®Go expression platform and represents a further milestone in our strategy to continuously open up new areas for our technology. It also marks the transition of the Company towards a “Center of Expertise” in tailor-made glycosylation of recombinant proteins,” commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH. “Over recent months, we successfully positioned CAP®Go as the technology of choice in high growth areas including difficult to express glycoproteins for ex vivo cell culture therapies as well as therapeutically relevant plasma and serum proteins. Today, manufacturing is still a limiting factor for the therapeutic use of recombinant glycoproteins. Given the superior pharmacokinetic profiles shown by CAP®Go-derived glycoproteins, we are anticipating drug development companies to switch from CHO-Technologies and HEK 293-Technologies to our CAP®Go technology.”
“CEVEC’s CAP®Go technology and their expertise in cell line development, process development and manufacturing is crucial for us to meet the increasing demand of LN-521 as well as changing the laminin production process to meet regulatory guidelines for clinical use in advanced cell therapies,” said Kristian Tryggvason, Chief Executive Officer of BioLamina AB. “The highly efficient GMP production capabilities as well as the superior function of the proteins expressed with the CAP®Go platform allows us to maintain BioLamina’s high quality standards for our ex vivo cell culture laminin product portfolio”
About CEVEC Pharmaceuticals GmbH:
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®Go and CAP®GT are based on a unique human cellular expression system.
The CAP®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 such as high molecular mass multimeric proteins including laminins, coagulation factors and other therapeutically relevant serum proteins and provide authentic human post-translational modifications. Recombinant proteins expressed with the CAP®Go platform have shown enhanced activity and stability, and superior pharmacokinetic profiles.
The CAP®GT expression platform provides a fully scalable, regulatory endorsed production system for gene therapy vectors. CAP®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®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®Go and CAP®GT cells.
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About BioLamina AB:
BioLamina commercializes innovations that solve technical problems within the culturing of embryonic stem cells and other types of primary cells. Many of the products are based on human recombinant proteins called laminins. These laminins provide these cells a natural environment when they are first used to coat the plastic cell culture dishes. Many different types of cells thrive on these laminins because these same proteins surround different types of cells also in the human body. These and other innovations together solve many of the technical problems like reproducibility and low cell quality and therefore help development of new cell therapies. BioLamina was founded 2009.
For more information: www.biolamina.com
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