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.

Products (48)
Background

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-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-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.

HY-10219G

Rapamycin (GMP)	53123-88-9	mTOR
Rapamycin (Sirolimus) (GMP) is Rapamycin (HY-10219) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Rapamycin is a potent and specific mTOR inhibitor.

HY-10585G

Valproic acid (GMP)	99-66-1	Organoid HDAC Autophagy Mitochondrial Metabolism HIV Notch Apoptosis Endogenous Metabolite
Valproic acid (GMP) is Valproic acid (HY-10585) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Valproic acid (VPA) is an orally active HDAC inhibitor, with IC₅₀ in the range of 0.5 and 2 mM. Valproic acid inhibits HDAC1 (IC₅₀, 400 μM), and induces proteasomal degradation of HDAC2. Valproic acid activates Notch1 signaling and inhibits proliferation in small cell lung cancer (SCLC) cells. Valproic acid is used in the epilepsy, bipolar disorder, metabolic disease, HIV infection and prevention of migraine headaches.

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-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-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-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-B0166GL

L-Ascorbic acid (GMP Like)	50-81-7	Calcium Channel Reactive Oxygen Species Endogenous Metabolite Apoptosis
L-Ascorbic acid (GMP Like) is the GMP Like class L-Ascorbic acid (HY-B0166). L-Ascorbic acid (L-Ascorbate, Vitamin C), an electron donor, is an endogenous antioxidant agent. L-Ascorbic acid inhibits selectively Ca_v3.2 channels with an IC₅₀ of 6.5 μM. L-Ascorbic acid is also a collagen deposition enhancer and an elastogenesis inhibitor. L-Ascorbic acid exhibits anti-cancer effects through the generation of reactive oxygen species (ROS) and selective damage to cancer cells.

HY-14649G

Retinoic acid (GMP)	302-79-4	RAR/RXR
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-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-15764G

A 419259 (GMP)	364042-47-7	Src Apoptosis
A 419259 GMP is the GMP grade A 419259 (HY-15764), inducing cell apoptosis. GMP-grade small molecules can be used as auxiliary reagents in cell therapy. A 419259 (RK-20449) is a broad-spectrum pyrrole-pyrimidine inhibitor targeting Src, Lck, and Lyn with IC₅₀s of 9 nM, <3 nM, and <3 nM, respectively.

HY-B0166G

L-Ascorbic acid (GMP)	50-81-7	Calcium Channel
L-Ascorbic acid (L-Ascorbate) (GMP) is L-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 Ca_v 3.2 channels.

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-10475G

AM580 (GMP)	102121-60-8	RAR/RXR
AM580 (CD336) (GMP) is AM580 (HY-10475) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. AM580 is a selective RARα agonist.

HY-B0185G

Lidocaine (GMP)	137-58-6	MEK NF-κB Sodium Channel Apoptosis ERK
Lidocaine (GMP) is Lidocaine (HY-B0185) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Lidocaine inhibits sodium channels involving complex voltage and using dependence. Lidocaine decreases growth, migration and invasion of gastric carcinoma cells via up-regulating miR-145 expression and further inactivation of MEK/ERK and NF-κB signaling pathways. Lidocaine is an amide derivative and has potential for the research of ventricular arrhythmia.

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 third-party on-site QP audit.