In order to utilize stem cell-based therapeutics in regenerative medicine, researchers first must be able to grow these cells on a large scale. Stem cells often have stringent growth requirements, with each cell type requiring a different set of growth media components.
Based on this need, Invitrogen, part of Life Technologies, set its sights on creating defined media and other reagents for stem cells. “There are 85 clinical trials that are now being run based on stem cell therapy, as listed in the National Institutes of Health clinical trials database, and all of them need a way to manufacture their cells under a regulatory regimen,” said Mahendra Rao, M.D., Ph.D., vp of R&D. And those manufacturing processes will require defined growth media.
Dr. Rao talked about some of Invitrogen’s recent stem cell technologies. “Our focus has been on the two stem cell types on which most of the clinical trials were being performed—mesenchymal and embryonic stem cells.”
In order to provide researchers with a more defined media for stem cell growth, Invitrogen needed to eliminate serum from its stem cell media formulas, and the company has been successful at developing whole cell growth systems for stem cells, Dr. Rao said. These media were designed to enable researchers to manufacture stem cells on a large scale.
Cell purity is essential for reliable and reproducible screening, and cell type-specific technologies that do not alter cell viability are critical to establishing successful screening models, noted Dr. Rao, who also presented a bead-based technology developed by the company’s Dynal division, which allows for positive selection using a detach-a-bead system or a depletion process using negative selection. These technologies are used to isolate and purify primary stem cells for use in drug and toxicology screening.
In addition, Dr. Rao presented data on two of Invitrogen’s gene delivery systems for stem cells—a baculovirus-based system and the Jump-In™ vector system. The company uses integrase-based technology to target integration of a gene into a specific site in the genome. The Jump-In vector system allows the user to create multiple gene variants and to measure direct gene expression with high reproducibility and a high degree of control, he said.
“These two gene delivery technologies, combined with our ability to manufacture purified cells has really allowed us to do certain kinds of screening that were not possible before,” Dr. Rao added.
Advancement of regenerative medicine is contingent upon developments in stem cell technologies, creating a symbiotic relationship that represents a current impetus for change in biomedical research. Technologies presented at this year’s “World Stem Cell Summit” will likely serve as the roadmap for such change.