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| Good Manufacturing Practice (GMP) is a guideline ensures safety, quality, and consistency of medical products. GMP small molecules are used as ancillary reagents in the manufacturing of many stem cell therapy products and are essential throughout the workflow, from reprogramming, self-renewal to differentiation. Produced in strict compliance with cGMP (current GMP) guidelines, our GMP small molecules offer reliable, safe, consistent and quality-assured ancillary reagents for cell therapies. Additionally, MedChemExpress (MCE) provides comprehensive documentation and licenses required for project submissions and official on-site audits during the Investigational New Drug (IND) to New Drug Application (NDA) stages. |
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| Product Quality Assurance |
| Our GMP small molecules are synthesized following ICH Q7 guidelines. Each batch undergoes strict QC testing, including: |
• Purity
• Water Content
• Residual Solvents
• Bioburden
• Endotoxin
• Elemental Impurities
• Solublity |
| Product Documentation |
| Each product is accompanied by essential documentation, including: |
• Certificate of Analysis (CoA)
• Safety Data Sheet (SDS)
• Certificate of Origin (CoO)
• TSE/BSE Statement
• Product Specifications
• Declaration of GMP Compliance |
| Key Benefits of MCE GMP Small Molecules |
• High purity, excellent stability, and batch-to-batch consistency with traceability of sources.
• Fast delivery with many products in stock, reducing time costs.
• Wide range of categories to meet various research and application demands.
• Support materials available for drug application submissions and audits.
• Kilogram-level production capacity with quality control system that has passed EU third-party QP audits. |
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MCE Provides a Variety of GMP Small Molecules |
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| MCE also offers customized synthesis services for GMP small molecules. |
| Additionally, MCE provides GMP products for recombinant proteins, and ADC-related products, catering to various derivative needs. |
References: |
[1] Nature. 2022;605(7909):325-331.
[2] Science. 2016;352(6290):1216-1220.
[3] Cell Stem Cell. 2021;28(2):343-355.e5.
[4] Nat Med. 2022 Feb;28(2):272-282.
[5] STAR Protoc. 2020 Oct 16;1(3):100130.
[6] Nature. 2023 May;617(7962):792-797.
[7] Stem Cell Reports. 2018;10(5):1505-1521. |
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Products are for research use only and are not intended for human use. We do not sell to patients.
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