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 (185)
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Niclosamide (GMP) is Niclosamide (HY-B0497) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Niclosamide (BAY2353) is an orally active antihelminthic agent used in parasitic infection research. Niclosamide is a STAT3 inhibitor with an IC50 of 0.25 μM in HeLa cells. Niclosamide has biological activities against cancer, inhibits DNA replication in Vero E6 cells.
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Ribavirin (GMP) is Ribavirin (HY-B0434) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Ribavirin (ICN-1229) is an antiviral agent against a broad spectrum of viruses including HCV, HIVl, and RSV. Ribavirin also has anti-orthopoxvirus and anti-variola activities.
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Ciclopirox (olamine) (GMP) is Ciclopirox olamine (HY-B0450A) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Ciclopirox (HOE296b) is a synthetic antifungal agent that can be used for superficial mycoses reseaech. Ciclopirox olamine has a very broad spectrum of activity and inhibits dermatophytes, yeasts, molds, and many Gram-positive and Gram-negative species pathogenic.
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Fenofibrate (GMP) is Fenofibrate (HY-17356) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Fenofibrate is a selective PPARα agonist with an EC50 of 30 μM. Fenofibrate also inhibits human cytochrome P450 isoforms, with IC50s of 0.2, 0.7, 9.7, 4.8 and 142.1 μM for CYP2C19, CYP2B6, CYP2C9, CYP2C8, and CYP3A4, respectively.
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Indomethacin (GMP) is Indomethacin (HY-14397) produced by using GMP guidelines. GMP small molecules work appropriately as an auxiliary reagent for cell therapy manufacture. Indomethacin (Indometacin) is a potent, orally active COX1/2 inhibitor with IC50 values of 18 nM and 26 nM for COX-1 and COX-2, respectively. Indomethacin has anticancer activity and anti-infective activity. Indomethacin can be used for cancer, inflammation and viral infection research.
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Mertansine (GMP) is the GMP-grade version of Mertansine (HY-19792). Mertansine (DM1) is a microtubulin inhibitor and is an antibody-conjugatable maytansinoid that is developed to overcome systemic toxicity associated with maytansine and to enhance tumor-specific delivery. Mertansine can be attached to a monoclonal antibody with a linker to create an antibody-drug conjugate (ADC).
ALC-0315 (GMP) is an ionisable aminolipid that is responsible for mRNA compaction and aids mRNA cellular delivery and its cytoplasmic release through suspected endosomal destabilization. ALC-0315 (GMP) can be used to form lipid nanoparticle (LNP) delivery vehicles. Lipid-Nanoparticles have been used in the research of mRNA COVID-19 vaccine.
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ALC-0159 (GMP) is the GMP-grade form of ALC-0159 (HY-138300). GMP-grade small molecules can serve as auxiliary reagents in cell therapy. ALC-0159 is a pegylated lipid that acts as a component of mRNA lipid nanoparticles (LNPs). ALC-0159 presents highly mobile surface PEG chains in a dense brush-like conformation, which can form a hydrophilic barrier, reduce non-specific protein adsorption and macrophage uptake, improve colloidal stability, prolong in vivo circulation time, and affect the cellular uptake of LNPs. ALC-0159 dissociates from the surface of mRNA-LNPs under long-term mechanical oscillation stress, thereby reducing steric hindrance, inducing mRNA-LNP fusion, increasing particle size, and releasing unencapsulated mRNA.
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Tartrazine (GMP) (Acid Yellow 23 (GMP); FD&C Yellow No. 5 (GMP)) is the GMP-grade form of Tartrazine (HY-D0257). Tartrazine is an orally active azo-type acid dye, appearing as an orange-yellow powder that dissolves in water to form a yellow solution. It is primarily used as a synthetic lemon-yellow azo dye for food coloring. Tartrazine is one of the most stable colorants. Tartrazine induces mitochondria-mediated apoptosis. Tartrazine causes neurodevelopmental toxicity, cytotoxicity, and genotoxicity.
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L-Citrulline GMP is an orally active, blood-brain barrier permeable neutral α-amino acid. L-Citrulline GMP inhibits the mitochondrial translocation of Drp1 and maintains mitochondrial homeostasis via a NO-dependent pathway, thereby reducing excessive ROS production. Consequently, L-Citrulline GMP protects sperm DNA integrity, stabilizes the blood-testis barrier and improves semen quality. L-Citrulline GMP can be used in research related to male infertility, mycobacterial infection (tuberculosis) and radiation combined injury.
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4-Arm PEG5000-NH2 (GMP) (4-Arm PEG5000-amine (GMP)) is 4-Arm PEG-NH2 (HY-W1048843A) produced by using GMP guidelines. GMP small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. 4-Arm PEG5000-NH2 is a multi-arm PEG derivative with amine groups at each end of four arms attached to a pentaerythritol core. The reactive primary amine or NH2 groups can react rapidly with activated carboxylic acids such as NHS esters to form stable amide bonds.
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4-Arm PEG5000-NH2 (GMP Like) (4-Arm PEG5000-amine (GMP Like)) is 4-Arm PEG-NH2 (HY-W1048843A) produced by using GMP like guidelines. GMP like small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. 4-Arm PEG5000-NH2 is a multi-arm PEG derivative with amine groups at each end of four arms attached to a pentaerythritol core. The reactive primary amine or NH2 groups can react rapidly with activated carboxylic acids such as NHS esters to form stable amide bonds.
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DSPC (GMP Like) (1,2-Distearoyl-sn-glycero-3-phosphorylcholine) is DSPC (HY-W040193) produced by using GMP like guidelines. GMP Like small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. DSPC (1,2-Distearoyl-sn-glycero-3-phosphorylcholine) is a cylindrical-shaped lipid. DSPC is used to synthesize liposomes, and is the lipid component in the lipid nanoparticle (LNP) system.
ALC-0315 (GMP Like) is ALC-0315 (HY-138170) produced by using GMP like guidelines. GMP Like small molecules works appropriately as an auxiliary reagent for cell therapy manufacture. ALC-0315 is an ionisable aminolipid that is responsible for mRNA compaction and aids mRNA cellular delivery and its cytoplasmic release through suspected endosomal destabilization. ALC-0315 can be used to form lipid nanoparticle (LNP) delivery vehicles. Lipid-Nanoparticles have been used in the research of mRNA COVID-19 vaccine.
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Sucralose (GMP Like) (E955 (GMP Like)) is the GMP Like class Sucralose (HY-N0614) that can be used as pharmaceutical excipients. Sucralose (E955; Trichlorosucrose) is a non-nutritive artificial sweetener and sugar substitute. Sucralose can activate a conserved neural fasting response and thereby exerts an appetite-stimulating effect in rodents.
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Neotame (GMP Like) is the GMP Like class Neotame (HY-W011053) that can be used as pharmaceutical excipients. Neotame is a derivative of Aspartame (HY-B0361) and is a flavor enhancer and low-caloric, non-nutritive, high-intensity artificial sweetener that is 7000-13,000 times sweeter than sugar. Neotame causes intestinal epithelial cell death at high concentrations. Neotame induces Apoptosis of Caco-2 cells.
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Meglumine (GMP Like) (Methylglucamine (GMP Like)) is the GMP Like class Meglumine (HY-B0342) that can be used as pharmaceutical excipients. Meglumine (Methylglucamine) is an orally active amino sugar derived from sorbitol. Meglumine has anti-inflammatory and antitumor activity. Meglumine is often used as an excipient in active molecules and with iodinated compounds in contrast agents such as meglumine and meglumine iodide.
