GMP Small Molecules
Good Manufacturing Practice (GMP) is a guideline ensuring safety and high-quality of medical products. MCE offers two categories of GMP small molecules: one for Cell and Gene Therapy (CGT), and the other for Antibody-Drug Conjugate (ADC). At MCE, GMP Small Molecules are produced in strict accordance with cGMP guidelines. If required, MCE provides with relative materials and license for project declarations and official on-site audits in period of IND to NDA.
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GMP Molecules for Cell and Gene Therapy (CGT) (147)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.
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GMP Small molecules for Antibody-drug Conjugate(ADC) (28)GMP (Good Manufacturing Practice) is the fundamental principle for drug production and quality management. GMP ADC related small molecule products include ADC Payload, ADC Linker+Payload, and related intermediate. The GMP ADC related small molecule products provided by MCE strictly follow the cGMP guidelines for production, with reliable quality and high cost-effectiveness. MCE has successfully filed a series of products with the FDA, and this type of product has completed systematic and complete quality research work, supporting the declaration work and on-site audit from IND to NDA.
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GMP Small Molecules (186)
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Calcium phosphate (GMP Like) (Secondary calcium (GMP Like)) is the GMP Like class Calcium phosphate (HY-B2242) that can be used as pharmaceutical excipients. Calcium phosphate is a biochemical reagent that can be used as a biological material or organic compound for life science related research.
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BI 2536 (GMP) is BI 2536 (HY-50698) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. BI 2536 is a dual PLK1 and BRD4 inhibitor with IC50s of 0.83 and 25 nM, respectively. BI-2536 suppresses IFNB (encoding IFN-β) gene transcription.
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D-Sorbitol, M200 (GMP Like) is the GMP Like class D-Sorbitol, M200 that can be used as pharmaceutical excipients. D-Sorbitol (Sorbitol) is a six-carbon sugar alcohol and can used as a sugar substitute. D-Sorbitol can be used as a stabilizing excipient and/or isotonicity agent, sweetener, humectant, thickener and dietary supplement.
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GSK-1070916 (GMP) is GSK-1070916 (HY-70044) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. GSK-1070916 is a potent and selective ATP-competitive inhibitor of aurora B and aurora C with Kis of 0.38 and 1.5 nM, respectively, and is >250- fold selective over Aurora A.
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MG-132 (GMP) (Z-Leu-Leu-Leu-al (GMP)) is MG-132 (HY-13259) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. MG-132 (Z-Leu-Leu-Leu-al) is a potent proteasome and calpain inhibitor with IC50s of 100 nM and 1.2 μM, respectively. MG-132 effectively blocks the proteolytic activity of the 26S proteasome complex. MG-132, a peptide aldehyde, also is an autophagy activator. MG-132 also induces apoptosis.
Romidepsin (GMP) (FK 228 (GMP)) is Romidepsin (HY-15149) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Romidepsin (FK 228) is a Histone deacetylase (HDAC) inhibitor with anti-tumor activities. Romidepsin (FK 228) inhibits HDAC1, HDAC2, HDAC4, and HDAC6 with IC50s of 36 nM, 47 nM, 510 nM and 1.4 μM, respectively. Romidepsin (FK 228) is produced by Chromobacterium violaceum, induces cell G2/M phase arrest and apoptosis.
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Bortezomib (GMP) (PS-341 (GMP)) is Bortezomib (HY-10227) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. Bortezomib (PS-341) is a reversible and selective proteasome inhibitor, and potently inhibits 20S proteasome (Ki=0.6 nM) by targeting a threonine residue. Bortezomib disrupts the cell cycle, induces apoptosis, and inhibits NF-κB. Bortezomib is the first proteasome inhibitor anticancer agent. Bortezomib can be used for the study of multiple myeloma (MM). Bortezomib effectively inhibits TREM2 expression in tumor-associated macrophages (TAMs).
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DOPE (GMP Like) is the GMP Like class DOPE (HY-112005), and can be used as pharmaceutical excipients. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. DOPE is a neutral helper lipid for cationic liposome and combines with cationic phospholipids to improve transfection efficiency of naked siRNA.
D-Lin-MC3-DMA (GMP Like) is the GMP Like class D-Lin-MC3-DMA (HY-112251). GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. D-Lin-MC3-DMA, an ionizable cationic lipid, is a potent siRNA delivery vehicle.
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TL8-506 (GMP) is TL8-506 (HY-20457) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. TL8-506 is a specific TLR8 agonist with an EC50 of 30?nM. TL8-506 has immunomodulatory effects and can be used in the study of tuberculosis and cancer immunotherapy.
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2-Ketoglutaric acid (Alpha-Ketoglutaric acid) Sodium (GMP) is 2-Ketoglutaric acid Sodium (HY-W013636A) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. 2-Ketoglutaric acid Sodium is an intermediate in the production of ATP or GTP in the Krebs cycle. 2-Ketoglutaric acid Sodium also acts as the major carbon skeleton for nitrogen-assimilatory reactions. 2-Ketoglutaric acid Sodium is a reversible inhibitor of tyrosinase (IC50=15 mM).
Z-VAD-FMK is a pan-caspase inhibitor and also an ICE-like protease inhibitor, which inhibits apoptosis by preventing the processing of CPP32 to its active form. Z-VAD-FMK sensitivity varies primarily due to differential expression of receptor-interacting protein 1 (RIP1). Z-VAD-FMK limits the cryopreservation-induced apoptosis by reducing caspase-3 activity of in vitro produced bovine embryos. Z-VAD-FMK is immunosuppressive in vitro and inhibits T cell proliferation without blocking the processing of caspase-8 and caspase-3. Z-VAD-FMK leads to a decrease in intracellular glutathione (GSH) with a concomitant increase in reactive oxygen species (ROS) levels in activated T cells. Z-VAD-FMK is due to oxidative stress via the depletion of GSH. Z-VAD-FMK can be used for the study of acute pancreatitis.
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Malic acid (GMP) is Malic acid (HY-Y1311) in GMP grade. GMP-grade small molecules can be used as auxiliary reagents in cell therapy. Malic acid (Hydroxybutanedioic acid) is a dicarboxylic acid that occurs naturally in fruits like apples and pears with oral activities. Malic acid plays a role in many sour or tangy foods. Malic acid is an intermediate in the citric acid cycle.
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Endo S2, Streptococcus pyogenes (GMP Like) is Endo S2, Streptococcus pyogenes (HY-E70069) produced by using GMP like guidelines. Endo-β-N-acetylglucosaminidase (Endo S2) is a key enzyme involved in the processing of free oligosaccharides in the cytosol. Endo-β-N-acetylglucosaminidase catalyzes hydrolysis of N-linked oligosaccharides.
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Tubastatin A (GMP) is the Tubastatin A (HY-13271A) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Tubastatin A is a potent and selective HDAC6 inhibitor with an IC50 of 15 nM in a cell-free assay, and is selective (1000-fold more) against all other isozymes except HDAC8 (57-fold more). Tubastatin A also inhibits HDAC10 and metallo-β-lactamase domain-containing protein 2 (MBLAC2).
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IWR-1 (IWR-1-endo) (GMP) is the IWR-1 (HY-12238) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. IWR-1 (IWR-1-endo) is a tankyrase inhibitor targeting Wnt/β-catenin (IC50 = 180 nM). IWR-1 compromises critical steps of the canonical Wnt signaling, namely translocation of β-catenin to the nucleus and subsequent TCF/LEF activation and expression of Wnt/β-catenin downstream targets. IWR-1 promotes β-catenin phosphorylation by promoting stability of Axin-scaffolded destruction complexes. IWR-1 can be studied in research for anti-tumor purposes, and diseases such as osteosarcoma, colorectal cancer and psoriasis.
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Hydrocortisone hemisuccinate GMP (Hydrocortisone 21-hemisuccinate GMP) is a GMP-grade version of Hydrocortisone hemisuccinate (HY-B1402). GMP-grade small molecules can be used as auxiliary reagents in cell therapy. Hydrocortisone hemisuccinate (Hydrocortisone 21-hemisuccinate), a glucocorticoid, is an orally active steroidal anti-inflammatory agent (SAID) with anti-inflammatory and immunomodulatory activities. Hydrocortisone hemisuccinate inhibits the bioactivity of IL-6 and IL-3 with IC50 values of 6.7 and 21.4 μM, respectively. Hydrocortisone hemisuccinate can be used in the study of ulcerative colitis (UC) and recurrent oral ulcers. .
IWP L6 (GMP) (Porcn Inhibitor III (GMP)) is IWP L6 (HY-15825) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. IWP L6 (Porcn Inhibitor III) is a Porcupine (Porcn) inhibitor with an EC50 of 0.5 nM. IWP L6 disrupts well-established Wnt-dependent developmental processes of embryonic and juvenile zebrafish.
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ART558 (GMP) is ART558 (HY-141520) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. ART558 is a potent, selective and allosteric DNA polymerase theta (Polθ) inhibitor (IC50=7.9 nM). ART558 elicits BRCA-gene synthetic lethality and DNA damage. ART558 can be used for the research of cancer, such as breast cancer.
