GMP Molecules for Cell and Gene Therapy (CGT)
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Cell Therapy
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High Purity
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Batch to Batch Consistency
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Good Security
GMP Small Molecules-Ancillary Reagents
Small molecules used in CGT have the advantages of strong spatiotemporal regulation, work faster, higher safety, and easy storage.
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Strong spatiotemporal regulation
The induction effect will change with changes in concentration and time, will have different effects in different experimental plans, and the biological effects are reversible.
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Work faster and higher safety
Small molecules can penetrate cells and have faster effects than gene editing methods, shortening the time of reprogramming and differentiation.
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Convenient storage and low cost
Most small molecule compounds are stable in nature, convenient to store, relatively small in dosage and quick to take effect, saving time and cost.
GMP vs RUO Small Molecules
| Difference | RUO grade | GMP grade |
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| The detection indicator | LCMS and other spectra to measure structure, purity, solubility. | Conventional: structure, purity, solubility. GMP indicators: water content, elemental impurities, residual solvents, endotoxin, bioburden, etc. Others: Special indicators for different products. |
| Analytical method validation | No | Strict analysis and verification are carried out to ensure that the final total impurity content is less than 1.0% (single impurities less than 0.15%, especially some toxic impurities). |
| Consistency between batches | Lower than GMP grade | All materials and synthesis processes are documented, with strong traceability, and consistency between batches is strictly maintained. |
| Stability | Lower than GMP grade | Conduct rigorous accelerated stability and long-term stability studies with comprehensive stability supporting documentation. Due to the strict control of impurities, such as solvent residues, bioburden, and endotoxins, etc., the product stability is very good. |
Product Quality Assurance
The MCE GMP Small Molecules are synthesized following ICH Q7 guidelines. Each batch undergoes strict QC tests, not limited to the following test items:
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Assay
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Water Content
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Residual Solvents
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Bioburden
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Endotoxin
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Elemental Impurities
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Solubility
Product Specific Documentation
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Certificate of Analysis (CoA)
Safety Data Sheet (SDS)
Certificate of Origin (CoO)
TSE/BSE Statement
Product Specifications
Declaration of GMP Compliance
Benefits of MCE GMP Small Molecules
- High purity, good stability, high consistency between batches, and traceability of sources.
- Many spot products, with short delivery times, reducing time costs.
- A wide variety of product categories, covering multiple directions of derivative demand.
- Provide support materials for drug applications and audits at each stage.
- Equipped with a kilogram-level production workshop, with strict quality control, and the system has passed the EU QP audit and the US FDA audit.
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GMP Molecules for Cell and Gene Therapy (CGT) (147)
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Target:
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Research Areas:
Y-27632 dihydrochloride (GMP) is the GMP level of Y-27632 dihydrochloride (HY-10583). GMP guidelines are used to produce Y-27632 dihydrochloride (GMP). GMP small molecules works appropriately as an auxiliary reagent for cell research manufacture. Y-27632 dihydrochloride is an orally active and ATP-competitive ROCK (Rho-kinase) inhibitor with antiepileptic effect.
Laduviglusib (CHIR-99021) (GMP) is Laduviglusib (HY-10182) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Laduviglusib is a potent, orally active and selective GSK-3α/β inhibitor.
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SB-431542 (GMP) is SB-431542 (HY-10431) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. SB-431542 is a TGF-β receptor kinase inhibitor (TRKI) in SMAD signaling.
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Retinoic acid (Vitamin A acid) (GMP) is Retinoic acid (HY-14649) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Retinoic acid is an agonist of RAR nuclear receptors.
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Target:
Calcium Channel
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Research Areas:
L-Ascorbic acid (L-Ascorbate) (GMP) is Ascorbic acid (HY-B0166) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. L-Ascorbic acid is an inhibitor of Cav 3.2 channels.
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Dexamethasone (Hexadecadrol) (GMP) is Dexamethasone (HY-14648) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Dexamethasone is an agonist of glucocorticoid receptor.
Staurosporine (AM-2282) (GMP) is Staurosporine (HY-15141) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Staurosporine is a potent, ATP-competitive and non-selective inhibitor of protein kinases.
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Target:
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Prostaglandin E2 (GMP) is Prostaglandin E2 (HY-101952) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Prostaglandin E2, an inflammatory mediator, is a endogenous hormone-like substance that participate in a wide range of body functions.
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DAPT (GSI-IX) (GMP) is DAPT (HY-13027) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. DAPT is a potent and orally active γ-secretase inhibitor.
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Target:
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LDN193189 GMP is LDN193189 (HY-12071) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. LDN193189 (DM-3189) is a potent selective BMP type I receptor (BMP I) inhibitor. LDN193189 efficiently inhibits transcriptional activity of the BMP type I receptors ALK2 and ALK3 with IC50 values of 5 nM and 30 nM, respectively. LDN193189 can be used for the research of bone morphogenetic protein signalling, such as fibrodysplasia ossificans progressiva.
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Target:
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Resiquimod (R848) (GMP) is Resiquimod (HY-13740) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Resiquimod is a Toll-like receptor 7 and 8 (TLR7/TLR8) agonist. Resiquimod (GMP) can induce human mMDSC to mature into inflammatory macrophages.
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Target:
Toll-like Receptor (TLR)
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Research Areas:
Polyinosinic-polycytidylic acid (Poly(I:C)) (GMP Like) is the GMP Like class Polyinosinic-polycytidylic acid (HY-107202), and can be used as pharmaceutical excipients. Polyinosinic-polycytidylic acid (Poly(I:C)) is a synthetic analog of double-stranded RNA and an agonist of toll-like receptor 3 (TLR3) and retinoic acid inducible gene I (RIG-I)-like receptors (RIG-I and MDA5). Polyinosinic-polycytidylic acid can be used as a vaccine adjuvant to enhance innate and adaptive immune responses, and to alter the tumor microenvironment. Polyinosinic-polycytidylic acid can directly trigger cancer cells to undergo apoptosis.
Mirdametinib (PD0325901) (GMP) is Mirdametinib (HY-10254) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Mirdametinib is an orally active, selective and non-ATP-competitive MEK inhibitor.
Thiazovivin (GMP) is Thiazovivin (HY-13257) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Thiazovivin is a potent ROCK inhibitor.
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Target:
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Purmorphamine (GMP) is Purmorphamine (HY-15108) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Purmorphamine is a smoothened/Smo receptor agonist with an EC50 of 1 μM.
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Target:
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Liothyronine (Triiodothyronine) (GMP) is the Liothyronine (HY-A0070A) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Liothyronine is a potent thyroid hormone receptors TRα and TRβ agonist with Kis of 2.33 nM for hTRα and hTRβ, respectively.
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Stemregenin 1 (SR1) (GMP) is a GMP-grade Stemregenin 1 (HY-15001). GMP-grade small molecules can be used as adjuvants in cell therapy. Stemregenin 1 is a potent aryl hydrocarbon receptor (AhR) antagonist with an IC50 of 127 nM. Stemregenin 1 (GMP) can competitively bind to AhR and inhibit its nuclear translocation, inhibiting osteoclastogenesis and promoting hematopoietic progenitor cell expansion by blocking the AhR-c-src-NF-κB/p-ERK MAPK-NFATc1 signaling pathway. Stemregenin 1 (GMP) can be used for the study of osteoporosis, in vitro expansion of hematopoietic stem cells, and the study of the mechanism of bone metabolic diseases.
