1. GMP Small Molecules

GMP Molecules for Cell and Gene Therapy (CGT)

Cell therapy High purity Batch to batch consistency Good security

Good Manufacturing Practice (GMP) is a guideline ensuring safety and high-quality of medical products. GMP Small Molecules are used as ancillary reagents in the manufacture of stem cell therapies, and are needed at all stages of work flow such as reprogram, self-renewal, proliferation, differentiation and storage. At MCE, GMP Small Molecules are produced in strict accordance with cGMP guidelines, assuring safe, reliable, consistent and quality-assured ancillary reagents for cell therapies. If required, MCE provides with relative materials and license for project declarations and official on-site audits in period of IND to NDA.

Cat. No. Product Name CAS No. Target
  • HY-10583G
    Y-27632 dihydrochloride (GMP)

    129830-38-2 ROCK
    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.
  • HY-10182G
    Laduviglusib (GMP)

    252917-06-9 GSK-3 Wnt β-catenin Autophagy
    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.
  • HY-10431G
    SB-431542 (GMP)

    301836-41-9 TGF-β Receptor
    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.
  • HY-13012G
    RepSox (GMP)

    446859-33-2 TGF-β Receptor
    RepSox (E-616452) (GMP) is a RepSox (HY-13012) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. RepSox is a potent and selective TGF-β-RI/ALK5 inhibitor.
  • HY-14649G
    Retinoic acid (GMP)

    302-79-4 RAR/RXR PPAR Endogenous Metabolite Autophagy
    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.
  • HY-15371G
    Forskolin (GMP)

    66575-29-9 Adenylate Cyclase FXR Autophagy PKC
    Forskolin (Coleonol) (GMP) is a potent adenylate cyclase activator with an IC50 of 41 nM and an EC50 of 0.5 μM for type I adenylyl cyclase. Forskolin (GMP) is also an inducer of intracellular cAMP formation. Forskolin (GMP) induces differentiation of various cell types and activates pregnane X receptor (PXR) and FXR. Forskolin (GMP) exerts a inotropic effect on the heart, and has platelet antiaggregatory and antihypertensive actions. Forskolin (GMP) also induces autophagy.
  • HY-15893G
    DMOG (GMP)

    89464-63-1 HIF/HIF Prolyl-Hydroxylase
    DMOG (GMP) is the GMP level of DMOG (HY-15893). DMOG (GMP) is a HIF-1α stabilizer. DMOG (GMP) promotes the osteogenic, angiogenic, and chondrogenic differentiation of stem cells by stabilizing the expression of HIF-1α. DMOG (GMP) can enhance the osteogenic and angiogenic differentiation potential of stem cells, thereby improving bone regeneration in bone defects. DMOG (GMP) can be used in the research of bone defect repair, vascularized bone regeneration, and the treatment of bone-related diseases (such as osteoporosis and femoral head necrosis) .
  • HY-15233G
    Letermovir (GMP)

    917389-32-3 CMV
    Letermovir (GMP) is the GMP grade of Letermovir (HY-15233). Letermovir (GMP) is an orally active CMV inhibitor. Letermovir (GMP) targets the CMV terminase complex rather than CMV DNA polymerase and exerts its antiviral activity. Letermovir (GMP) can be used in the study of CMV infection.
  • HY-101952G
    Prostaglandin E2 (GMP)

    363-24-6 Endogenous Metabolite
    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.
  • HY-13257G
    Thiazovivin (GMP)

    1226056-71-8 ROCK
    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.
  • HY-13027G
    DAPT (GMP)

    208255-80-5 γ-secretase
    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.
  • HY-15001G
    Stemregenin 1 (GMP)

    1227633-49-9 Aryl Hydrocarbon Receptor
    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 treatment of osteoporosis, in vitro expansion of hematopoietic stem cells, and the study of the mechanism of bone metabolic diseases.
  • HY-13740G
    Resiquimod (GMP)

    144875-48-9 Toll-like Receptor (TLR)
    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.
  • HY-10432G
    A 83-01 (GMP)

    909910-43-6 Anaplastic lymphoma kinase (ALK)
    A 83-01 (GMP) is A 83-01 (HY-10432) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. A 83-01 is a potent ALK4/5/7 inhibitor.
  • HY-12318G
    IBMX (GMP)

    28822-58-4 Phosphodiesterase (PDE)
    IBMX (3-Isobutyl-1-methylxanthine) (GMP) is IBMX (HY-12318) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. IBMX is a broad-spectrum phosphodiesterase (PDE) inhibitor.
  • HY-12071G
    LDN193189 (GMP)

    1062368-24-4 TGF-β Receptor
    LDN193189 (DM-3189) (GMP) is LDN193189 (HY-12071) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. LDN193189 is selective BMP type I receptor inhibitor.
  • HY-13912G
    IWP-2 (GMP)

    686770-61-6 Wnt
    IWP-2 (GMP) is IWP-2 (HY-13912) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. IWP-2 is an inhibitor of Wnt processing and secretion with an IC50 of 27 nM. IWP-2 targets the membrane-bound O-acyltransferase porcupine (Porcn) and blocks Wnt ligand palmitoylation.
  • HY-10254G
    Mirdametinib (GMP)

    391210-10-9 MEK
    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.
  • HY-15147G
    XAV-939 (GMP)

    284028-89-3 PARP
    XAV-939 (GMP) is XAV-939 (HY-15347) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. XAV-939 is a tankyrase inhibitor.
  • HY-14648G
    Dexamethasone (GMP)

    50-02-2 Glucocorticoid Receptor ADC Cytotoxin
    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.

GMP Small Molecules-Ancillary Reagents for Cell and Gene Therapy

Small molecules used in CGT have the advantages of strong spatiotemporal regulation, work faster, higher safety (small molecules do not have the genetic risks of traditional gene editing methods), and easy storage.

  • (1) 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.
  • (2) 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.
  • (3) 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.

What is the difference between GMP grade and RUO grade small molecules?

Difference RUO grade GMP grade
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 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:

  • Purity
  • Water Content
  • Residual Solvents
  • Bioburden
  • Endotoxin
  • Elemental Impurities
  • Solubility

Product Specific Documentation:

  • • 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.