GMP Small Molecules as Ancillary Reagents
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.
GMP Small Molecules
|
Product Name |
Catalog # |
Description |
|---|---|---|
|
TB4423-GMP |
GSK-3 Inhibitor and WNT pathway activator. Enables reprogramming of human somatic cells into iPSCs |
|
|
TB6053-GMP |
Potent and selective ALK2 and ALK3 inhibitor. Promotes neural induction of hPSCs |
|
|
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 iPSCs undergoing cryopreservation |
Additional GMP Products and Services
GMP Cytokines and Growth Factors
GMP Cytokines and Growth Factors
Our large portfolio of GMP proteins is backed by our dedication to providing cell therapy manufacturers with a consistent, safe, and traceable supply of reagents.
Custom GMP Antibodies
Custom GMP Antibodies
Our GMP antibodies are manufactured recombinantly for use in drug discovery, diagnostic, and cell & gene therapy manufacturing processes.
GMP Capabilities
GMP Capabilities
Learn about the quality standards and certifications for each of our GMP facilities as well as our quality control testing capabilities. We serve clients from around the world, and we guarantee the confidentiality of every contract.
GMP Cell Manufacturing and Process Development
GMP Cell Manufacturing and Process Development
We offer process development services for any gene modified therapy, GMP patient processing for Phase I and Phase II clinical trials, and GMP manufacturing of iPSC cell lines.
GMP Small Molecule Resources
eBook: T Cell-Based Therapies
eBook: T Cell-Based Therapies
This eBook outlines biological and manufacturing challenges facing T cell therapies. It follows with examples of how Bio-Techne products and services address these challenges.
Poster: Stem Cell Workflow Using Small Molecules
Poster: Stem Cell Workflow Using Small Molecules
Our Tocris 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.
About GMP Small Molecules
GMP small molecules are important in the manufacture of stem cell therapies for translational research and clinical applications, where they are used as ancillary reagents. Ancillary reagents are utilized in the growth and manipulation of stem cells. 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 reagents is advisable.
The clinical phases of development of any therapy are highly regulated in order to mitigate the risk to patient safety, and this includes the use of GMP ancillary reagents (raw materials) for developing stem cell therapies. 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.
View Our Cell and Gene Therapy Resources
Serum-Free and Animal-Free Cell Culture
Increase the consistency of your cell cultures as you approach translational studies for regenerative medicine and cell therapy programs. Adopting these media will
- Reduce variability in media composition
- Simplify compliance with regulatory guidelines
- Simplify comparability testing for raw material changes
New! ExCellerate™ GMP iPSC Expansion Medium
For seamless transition from our equivalent RUO iPSC Expansion Medium. Both media support robust expansion and maintenance of pluripotent stem cell culture for enhanced consistency and reproducibility.
- Completely animal-free
- All-in-one formulation
- Stable cell integrity over long term culture
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 reagents. Ancillary reagents are utilized in the growth and manipulation of stem cells. 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 reagents is advisable.
The clinical phases of development of any therapy are highly regulated in order to mitigate the risk to patient safety, and this includes the use of GMP ancillary reagents (raw materials) for developing stem cell therapies. 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.
View Our Cell and Gene Therapy Resources
What is the difference between RUO and GMP small molecules?
We manufacture our GMP (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 reagents, produced in compliance with GMP) 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 reagents) of USP <1043>.
Each vial is weighed to a precise amount. We also carry out microbiological testing on our GMP small molecules, specifically endotoxin and bioburden testing.
Explore our Certificate of Analysis Finder Tool.
Are GMP small molecules animal-free?
Yes. We ensure that our GMP small molecules are animal-free.
Can GMP small molecules be used as therapeutics?
No. Our GMP compounds are intended for use only as ancillary reagents for the further manufacture of advanced therapy medicinal products (ATMP), such as stem cell therapies.
Watch our webinar on the Challenges of Analyzing ATMPs.
Why has Bio-Techne developed a GMP product line?
As stem cell therapies are now entering the clinic, there is a requirement to use GMP compounds as ancillary reagents to ensure the safety and suitability of the stem cell therapy product. By introducing a GMP 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.