2. 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-N0565AG
    Doxycycline (hydrochloride) (GMP)

    		10592-13-9 Apoptosis MMP Akt PI3K
    Doxycycline hydrochloride GMP is Doxycycline (hydrochloride) (HY-N0565A) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Doxycycline hydrochloride is an orally active highly lipophilic, tissue-permeable MMP inhibitor with broad-spectrum antibacterial activity. Doxycycline hydrochloride is also a semi-synthetic antibiotic with chelating properties, which blocks bacterial protein synthesis and inhibits extracellular matrix degradation through interactions with zinc and calcium atoms. Doxycycline hydrochloride also inhibits mitochondrial biogenesis, translation, and the expression of respiratory chain proteins. Doxycycline hydrochloride induces apoptosis, inhibits autophagy and EMT, downregulates stem cell markers, and activates the PI3K-AKT pathway, thereby effectively inhibiting the viability and proliferation of cancer cells such as breast cancer cells. Doxycycline hydrochloride also promotes the survival and self-renewal of embryonic stem cells and neural stem cells, and reduces the frequency of medium changes in culture. Doxycycline hydrochloride has been applied in studies related to breast cancer, prostate cancer, bladder cancer, and other cancers.
  • HY-B0356G
    Ciprofloxacin (GMP)

    		85721-33-1 Bacterial Topoisomerase Akt β-catenin
    Ciprofloxacin GMP is Ciprofloxacin (HY-B0356) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Ciprofloxacin (Bay-09867) is an orally active, blood-brain barrier permeable fluoroquinolone antibacterial agent. Ciprofloxacin exerts bactericidal effects primarily by inhibiting topoisomerase II and IV. Ciprofloxacin inhibits the proliferation of human dental pulp stem cells and chondrocytes from young rats, and also activates the Akt signaling pathway and upregulates markers such as β-catenin and Nanog to maintain the morphological characteristics of stem cells. Ciprofloxacin induces significant neurotoxicity and tissue damage, including reducing serotonin and glutathione levels in the brain, inducing oxidative stress and depression-like behaviors, and causing articular cartilage damage. Ciprofloxacin can be applied to research related to infections of necrotic young permanent teeth and neurotoxicity.
  • HY-N0390G
    L-Glutamine (GMP)

    		56-85-9 mTOR NF-κB STAT HIF/HIF Prolyl-Hydroxylase
    L-Glutamine GMP is L-Glutamine (HY-N0390) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. L-Glutamine is an orally active nutritional agent and cellular metabolism regulator. L-Glutamine is taken up in a Na+-dependent manner and targets multiple key molecules including glutaminase, mTORC1, NF-κB, STAT-3 and HIF-1α. L-Glutamine enhances glutaminolytic catabolism, drives the conversion of glutamate to α-ketoglutarate, thereby regulating gene expression, integrating metabolic signals, mediating glutamine flux and maintaining redox homeostasis. L-Glutamine also promotes cell proliferation, osteogenic differentiation and fracture healing, exerts neuroprotective and cardioprotective effects, and inhibits osteoarthritis. L-Glutamine can be applied to research related to osteoporosis, osteoarthritis, ischemic stroke and acute cantharidin-induced cardiotoxicity.
  • 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-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-12071G
    LDN193189 (GMP)

    		1062368-24-4 Organoid TGF-β Receptor
    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.
  • 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-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-B0166G
    L-Ascorbic acid (GMP)

    		50-81-7 Reactive Oxygen Species (ROS) Calcium Channel Apoptosis Endogenous Metabolite
    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.
  • 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-B0445GL
    NAD+ (GMP Like)

    		53-84-9 Endogenous Metabolite
    NAD+ (GMP Like) is NAD+ (HY-B0445) produced by using GMP like guidelines. GMP Like small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. NAD+ is a coenzyme composed of ribosylnicotinamide 5'-diphosphate coupled to adenosine 5'-phosphate by pyrophosphate linkage.
  • HY-107202GL
    Polyinosinic-polycytidylic acid (GMP Like)

    		24939-03-5 Toll-like Receptor (TLR) PKD HSP Bcl-2 Family Interleukin Related Apoptosis
    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.
  • 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-15108G
    Purmorphamine (GMP)

    		483367-10-8 Smo
    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.
  • 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 study of osteoporosis, in vitro expansion of hematopoietic stem cells, and the study of the mechanism of bone metabolic diseases.

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.