GMP Grade Small Molecules
Enhance your reagent quality and safety for preclinical and clinical cell therapies.
Overview | GMP Grade | GMP Standards | Clinical Applications | AM Grade
Identifying a reliable GMP raw materials supplier in preclinical development and transitioning early from RUO (research use only) to GMP can help avoid time-consuming and expensive comparative studies during later stages of therapeutic development. cGMP (current good manufacturing practice) small molecule inhibitors from Tocris Bioscience are produced with a higher level of scrutiny, comprehensive documentation, and robust quality control. This ensures that the material is high quality and able to meet the additional compliance requirements of clinical trials and enables the safety of the final product.
GMP small molecules are suitable in cell therapies as raw materials and ancillary reagents for further ATMP (Advanced Therapy Medicinal Products) manufacturing processes.
GMP grade small molecules offer:
- Animal-free origin and production
- Raw materials traceability
- Batch-to-batch consistency
- Enhanced quality control and documentation
Small Molecules Synthesized to GMP Grade | ||
Small Molecule | GMP Grade | RUO Equivalent |
| CHIR 99021 | TB4423-GMP | 4423 |
| LDN 193189 | TB6053-GMP | 6053 |
| SB 431542 | TB1614-GMP | 1614 |
| XAV 939 | TB3748-GMP | 3748 |
| Y-27632 dihydrochloride | TB1254-GMP | 1254 |
GMP Quality Assurance and Quality Control Standards
We go above and beyond to ensure the highest quality standards. GMP compounds are synthesized under a quality assured manufacturing system and subjected to stringent quality control following cGMP guidelines. Rigorous testing and full traceability ensure batch-batch consistency. Manufacturing is ISO 9001:2015 certified and conforms to ICH Q7 guidelines where applicable (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
Analytical Tests Performed
• Purity and chiral purity by HPLC
• Identification by FTIR and/or NMR
• Water content - Karl Fischer
• Residue on ignition
• Residual solvents
• Solubility
• Bioburden
• Endotoxin
Documentation Available by Request
- Certificate of Analysis (CoA)
- Safety Data Sheet (SDS)
- Product Specifications
- TSE/BSE statement (Transmissible Spongiform Encephalopathy / Bovine Spongiform Encephalopathy)
Regulatory & Supply Support Provided
• Auditing of manufacturing facility in Bristol, UK
• Supply agreements and batch reservations
• Change notifications and quality agreements
• Point of contact throughout development process
Clinical Applications for Small Molecules in Cell Therapies
Our Ancillary Material Grade and GMP Grade small molecules are designed to support the development and manufacture of stem cell therapies and to accelerate transitioning cell therapies from preclinical research to the clinic.
Directed differentiation of stem cells for regenerative medicine and immune cell therapies may be controlled using small molecules and growth factors. Small molecules offer several advantages for cell therapy manufacture when compared to gene expression methods of stem cell reprogramming and differentiation:
• Synthetic production - high purity and low batch-to-batch variation ensure consistent activity and reproducible results
• Synthetic origin - reduced risk of unwanted genetic material entering your process
• Reversible mechanisms of action - enabling temporal control
• Scalable production - large volumes of reagents available for scale-up into the clinic
Ancillary Material Grade Small Molecules
AM grade small molecules are intended to be utilized as ancillary reagents in the manufacture of preclinical cell therapies. Specifically, they are to be used in the manipulation and culture of cells but are not intended to be present in the final cell therapy product. To support the path to-and through-the clinic, AM grade materials are manufactured with enhanced validation and testing beyond standard RUO reagents.
Small Molecules Synthesized to Ancillary Material Grade | ||
Small Molecule | Ancillary Material Grade | RUO Equivalent |
| A 83-01 | TB2939-RMU | 2939 |
| L-Ascorbic Acid | TB4055-RMU | 4055 |
| DAPT | TB2634-RMU | 2634 |
| Dexamethasone | TB1126-RMU | 1126 |
| DZNep HCl | TB4703-RMU | 4703 |
| Forskolin | TB1099-RMU | 1099 |
| endo-IWR 1 | TB3532-RMU | 3532 |
| Nicotinamide | TB4106-RMU | 4106 |
| RepSox | TB3742-RMU | 3742 |
| Retinoic Acid | TB0695-RMU | 0695 |
| Staurosporine | TB1285-RMU | 1285 |
| T3 | TB6666-RMU | 6666 |
| TCS JNK 6o | TB3222-RMU | 3222 |
1. What are GMP grade small molecules?
GMP grade small molecules are chemical compounds manufactured under Good Manufacturing Practice standards, ensuring higher levels of documentation, purity, testing, and traceability compared to RUO (research use only) materials. They are suitable for use as raw materials and ancillary reagents in clinical and preclinical cell therapy manufacturing.
2. How do GMP small molecules differ from RUO reagents?
GMP small molecules undergo enhanced quality control, animal‑free production, batch consistency testing, and regulatory documentation such as CoAs, SDS, and TSE/BSE statements. RUO materials lack the compliance and documentation required for clinical applications.
3. Why are GMP grade small molecules important in cell therapy manufacturing?
They support consistent, safe, and compliant manufacturing by reducing variability, ensuring traceability, and preventing contamination risks. Their synthetic nature minimizes genetic contamination risks and supports scalable, reproducible processes essential for clinical translation.
4. What tests are performed on GMP grade small molecules?
Common tests include HPLC purity and chiral purity, FTIR and/or NMR identification, residual solvent analysis, Karl Fischer water content, solubility testing, bioburden, and endotoxin measurements.
5. What documentation accompanies GMP small molecules?
Typical documentation includes Certificates of Analysis, Safety Data Sheets, Product Specifications, and TSE/BSE statements. Additional materials like change notifications, supply agreements, and audit reports may be available.
6. What applications use GMP grade small molecules?
Applications include stem cell differentiation, iPSC reprogramming, immune cell activation, regenerative medicine, and manufacturing of ATMPs for preclinical and clinical workflows.
7. How do GMP small molecules support regulatory compliance?
They follow ICH Q7 guidelines, ISO 9001-certified manufacturing, full traceability, and QC protocols, helping manufacturers meet regulatory expectations for ATMP and cell therapy products.
8. Which GMP small molecules are commonly used in cell therapy?
Molecules include CHIR 99021, LDN 193189, SB 431542, XAV 939, and Y‑27632, all frequently used in stem cell differentiation, reprogramming, and culture workflows.