1. GMP Small Molecules

GMP Small Molecules

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

The MCE GMP small molecules are synthesized following ICH Q7 guidelines. Each batch of MCE GMP small molecules has strict QC tests:

  • Purity
  • Water Content
  • Residual Solvents
  • Solubility
  • Endotoxin
  • Bioburden
  • Others