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.

  • GMP Molecules for Cell and Gene Therapy (CGT) (146)

    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.

  • 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.