cGMP Small Molecules as Ancillary Materials
Stem cells offer great potential for use as therapies in regenerative medicine. They can be used to generate cells to replace lost or unhealthy cells in a wide range of conditions including trauma, diabetes and Parkinson’s disease. The small molecules used as ancillary materials in the generation of stem cell therapies are required to be safe, reliable, consistent and quality-assured in order to ensure the safety of the stem cell therapy. Our GMP Small Molecules, manufactured according to cGMP guidelines, provide this assurance.
Available GMP Small Molecules
Product Name |
Catalog # |
Description |
|---|---|---|
TB4423-GMP |
GSK-3 Inhibitor; WNT pathway activator. Enables reprogramming of human somatic cells into iPSCs |
|
TB1614-GMP |
TGF Beta 1 (TGF-β1), ALK4 and ALK7 Inhibitor. Replaces SOX2 in reprogramming of fibroblasts to iPSCs |
|
TB3748-GMP |
Tankyrase Inhibitor; inhibits WNT signaling. Promotes cardiomyocyte differentiation from ESCs |
|
TB1254-GMP |
Selective ROCK Inhibitor. Increases survival of ESCs and |
View More GMP Products
GMP Proteins
GMP Proteins
Our large range of GMP proteins, including cytokines and growth factors, is backed by our dedication to providing cell therapy manufacturers with a consistent, safe, and traceable supply of reagents.
GMP Culture Media
GMP Culture Media
All components of ex vivo cell manufacturing need to be controlled, traceable, and scalable, including media and serum. Our GMP media production facility provides off-the-shelf and custom media for the further manufacture of immune and stem cell therapies.
GMP Small Molecule Resources
Brochure: Pioneering Cell & Gene Therapy Solutions
Brochure: Pioneering Cell & Gene Therapy Solutions
Our brochure provides an overview of the innovative products and services available from Bio-Techne to help further your cell and gene therapy research.
Poster: Stem Cell Workflow Using Small Molecules
Poster: Stem Cell Workflow Using Small Molecules
Our Stem Cell Workflow poster summarizes how small molecules have been used in protocols across the stem cell workflow, and highlights some of the key advantages of using small molecules.
Protocols: Key Stem Cell Protocol Highlights
Protocols: Key Stem Cell Protocol Highlights
Our Stem Cell Protocol snapshots highlight how small molecules may be used in place of or alongside proteins in cell culture, reprogramming and differentiation procedures.
Background Information
GMP small molecules are important in the manufacture of stem cell therapies for translational research and clinical applications, where they are used as ancillary materials (also known as AMs). Ancillary materials are utilized in the growth and manipulation of stem cells, and although they are not intended to be present in the final cell therapy product, they may influence its safety, so the use of GMP ancillary materials is advisable.
The clinical phases of development of any therapy are highly regulated in order to mitigate the risk to patient safety, so when developing stem cell therapies, there is a requirement for GMP ancillary reagents (also called raw materials) to assure suitability of the final product. Our GMP small molecules are manufactured following relevant sections of ICH Q7 guidelines (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), which ensures batch-to-batch consistency, traceability from starting material to final product and animal-free production.
What is the difference between RUO and cGMP small molecules?
We manufacture our cGMP (current Good Manufacturing Practice) small molecules according to relevant sections of ICH Q7 guidelines. They can be categorized in the risk tier 2 classification (low risk, well characterized materials with intended use as ancillary materials, produced in compliance with cGMP) of USP <1043>. Our RUO (research use only) products, like those of other suppliers, are categorized in the risk tier 3 classification (moderate-risk materials not intended for use as ancillary materials) of USP <1043>.
Each vial is weighed to a precise amount. We also carry out microbiological testing on our cGMP small molecules, specifically endotoxin and bioburden testing.
Are cGMP small molecules animal free?
Yes. We ensure that our cGMP small molecules are animal free.
Can cGMP small molecules be used as therapeutics?
No. Our cGMP compounds are intended for use only as ancillary materials for the further manufacture of advanced therapy medicinal products (ATMP), such as stem cell therapies.
Why has Bio-Techne developed a cGMP product line?
The clinical phases of cell therapy development are highly regulated, and as stem cell therapies are now entering the clinic, there is a requirement to use cGMP compounds as ancillary reagents, to ensure the safety and suitability of the stem cell therapy being developed. By introducing a cGMP product line, Bio-Techne is fulfilling its commitment to provide the life science community with the latest and most relevant reagents available, to make new discoveries possible.
