GMP Compounds for Cell Therapy Development Introduced by Tocris

First GMP Small Molecules for Stem Cell Therapy Manufacture

Tocris Bioscience, part of the Protein Sciences Segment of Bio-Techne, has introduced a new range of stem cell research compounds produced to cGMP (Current Good Manufacturing Practice*) standards, which are intended for use as ancillary (or raw) materials in the development of stem cell therapies.

Tocris has a highly-qualified team who have full control over the cGMP process meaning we can ensure from the outset: a quality assured manufacturing system, guaranteed batch-to-batch consistency, traceability from starting material to final product, and consistency of supply. GMP compounds are synthesized in accordance with relevant sections of ICH Q7 guidelines, and are classified as tier 2 risk in the USP <1043> guidelines. Working to these guidelines we are providing ancillary reagents suitable for stem cell therapy development, reducing the risk associated with research use only reagents. The first compounds to be released in our GMP range are SB 431542 and DAPT, which are widely used in stem cell differentiation and reprogramming protocols; these will be followed by Y-27632, CHIR 99021, and XAV 939.

Small molecules have a wide range of applications in stem cell research including reprogramming, differentiation, maintenance, and proliferation. They can also be used in combination or as replacements for growth factors and other proteins. The use of small molecules offers several advantages over alternative methods, including a rapid and reversible action, cell permeability to target intracellular signalling pathways, and concentration-dependent activity so they can be used in different protocols with different outcomes.

Dave Eansor, President of Bio-Techne's Protein Sciences Segment, commented, “We are really excited about the launch of these new GMP stem cell compounds. They will enable scientists to easily transition from the pre-clinical to clinical phase of stem cell therapy development. Alongside Bio-Techne’s R&D Systems-branded GMP proteins, their use will help advance research into the development of new stem cell therapies.”

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*Good Manufacturing Practice refers to a harmonized set of guidelines that set out procedures that will ensure safe, reliable, consistent and quality-assured products.


Contact: Dave Eansor, President, Protein Sciences Segment, 612-379-2956