1. GMP Small Molecules

GMP Small Molecules  

GMP(Good Manufacturing Products)是药品生产和质量管理的基本准则。GMP小分子化合物是细胞疗法生产中的辅助试剂,可用于干细胞的重编程、扩增和分化,但不会出现在最终产品中。MCE提供的GMP小分子严格遵守cGMP指南生产,保证小分子化合物的安全、可靠、稳定和高质量,确保在细胞治疗的安全性。如有需要,MCE还能提供相关的研发数据和资料,支持从IND到NDA过程中的申报工作和现场审计。

Good Manufacturing Products (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

MCE品牌的GMP系列小分子均按照 ICH Q7 指南相关章节进行生产, 每一批 GMP级小分子都经过严格质量把控,放行标准中包含但不限于以下检项:

  • 纯度 Purity
  • 水分 Water Content
  • 残留溶剂 Residual Solvents
  • 溶解度 Solubility
  • 内毒素 Endotoxin
  • 微生物 Bioburden
  • 其它 Others