BioLamina (Stockholm, Sweden) is a company developing, producing and marketing tools that help scientists handle different types of primary cells including stem cells. One of the main products is LN-521™, a human recombinant laminin-521, which has now shown to solve several critical technical problems that have been delaying or even blocking the development of cell therapy and regenerative medicine.

Only a few clinical trials have so far been performed with cells of embryonic stem cell origin since they were first isolated in 1998. One of the main reasons for this is that it has been extremely difficult to reproducibly manufacture cells for therapeutic applications in a way acceptable to the regulatory authorities. On January 27th, a new article published in Nature Communications presents how BioLamina's LN-521™ has solved several of these problems.

1. LN-521™ can be used to easily culture a large amount of human embryonic stem cells in a reproducible way, which has been extremely difficult until now. Using our tools, it is theoretically possible to produce over 400 kg (900 lb) of new embryonic stem cells in just over one month, which is an amount relevant for therapeutic purposes.

2. Using the most extensive genetic analysis so far published to analyze stem cell culture, the article shows that cells expanded on LN-521™ have no more changes in their genome than there are between ordinary individuals. This is a huge developmental advancement. Researchers have previously had significant problems with genetic mutations in cultured stem cells. However, this article shows that with the right and biorelevant cell culture condition, no abnormal mutations occur during the expansion of embryonic stem cells.

3. Our technology allows efficient development of new stem cell lines without need to destroy a human embryo. This can minimize or deplete many of the ethical problems associated with human embryonic stem cell research and therapy.

4. LN-521™ together with e-cadherin makes it easy and efficient to make stem cell banks from a large number of donors in a completely human and controlled environment. The produced stem cell lines would match any type of patient and thereby avoid immunological repulsion issues that are seen with organ transplantations.

To summarize, LN-521™ depletes most of the technical problems in development and culture of pluripotent stem cell lines. This helps standardize the cell culture process and thereby making it easier to enter clinical trials for embryonic stem cell based regenerative medicine.

Kristian Tryggvason the CEO of BioLamina comments: "LN-521™ has shown to be a great tool for embryonic stem cell derivation and culture and now we finally have all the proof supporting this published in a leading scientific journal. BioLamina and our collaborators are working on solving many other problems within the cell culture field using recombinant laminins and we hope to bring them to the general public as soon as possible."