BioLamina, a company develops and distributes high quality products for cell culture based on human recombinant laminins, is currently undergoing an exciting phase entering the growing cell and gene therapy reagents industry. In order to meet the growing demand for documentation and traceability required for the manufacture of cells for therapy, BioLamina has launched a cell therapy grade (CTG) laminin substrate for clinical use, Biolaminin 521 CTG.
"This is a significant milestone for BioLamina and for cell therapy developers around the world," says Kristian Tryggvason, CEO of BioLamina. "Finally there is a highly functional cell therapy grade product available that for the first time, allowing researchers to take their early protocols to clinical trials and onwards to commercialised therapy without significantly changing their manufacturing process."
Since 2009, BioLamina has been providing the stem cell research community with high quality research reagents that are often crucial for the potential cell therapy manufacturing process. BioLamina's best-selling product is human recombinant laminin 521, a cell culture substrate well documented and scientifically validated in numerous high-quality journals, such as Cell and Nature. The laminin 521 substrate has solved many manufacturing process-related issues, such as low cell quality and yield.
Over the last decade, laminin 521 has become a preferred cell culture substrate for both basic researchers and for researchers and companies with a therapeutic focus, and sales have increased significantly year after year. Following the derivation of human embryonic stem cells in 1998 and with the development of human induced pluripotent stem cells in 2007, great efforts have been made to create defined culture methods with high consistency, reproducibility and traceability of the reagents. This is even more important now as stem cell researchers are advancing their research projects to clinical studies with cell therapy candidates. The first CTG substrate, Biolaminin 521 CTG is now available for researchers and developers, helping the researchers all the way to enable cell therapy. "The regenerative medicine field is growing rapidly as more and more companies are entering clinical trials. It is such a great feeling to see this advancement and knowing we contribute to it," says Kristian Tryggvason, CEO of BioLamina.