Cevec and Biolamina combine technology leadership for commercial production of recombinant laminins for ex vivo cell therapies

First commercial CAPGo-derived laminin, LN-521, expected to be globally available in 2016.

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 CAPGo 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 CAPGo 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 CAPGo 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, CEO of CEVEC Pharmaceuticals. “Over recent months, we successfully positioned CAPGo 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 CAPGo-derived glycoproteins, we are anticipating drug development companies to switch from CHO-Technologies and HEK 293-Technologies to our CAPGo technology.”

“CEVEC’s CAPGo 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, CEO of BioLamina AB. “The highly efficient GMP production capabilities as well as the superior function of the proteins expressed with the CAPGo platform allows us to maintain BioLamina’s high quality standards for our ex vivo cell culture laminin product portfolio.”