Advanced cell therapies using immune cells (CAR T or Natural Killer Cells) and stem cells are rapidly progressing through clinical trials. Find the GMP raw materials you need by specific cell type.

CAR T

Natural Killer

Regulatory T Cell

Dendritic Cell

Hematopoietic Stem Cells

Pluripotent Stem Cells

Mesenchymal Stem Cells

Neural Cells

Each lot of GMP protein manufactured comes with a Certificate of Analysis (COA) that documents the quality systems and product specifications. Prior to protein COA release, a full QA review of all batch and bottling records is performed. Here is what you can expect to find on our COAs:

• Source information
• N-terminal sequencing of the first 10 amino acids
• Purity by SDS-PAGE and Mass Spectrometry
• Bioactivity testing calibrated to WHO International Standards
• Sterility testing to USP
• Endotoxin levels
• Certification and Regulatory Guidelines followed, including:
  • ISO 9001:2015, ISO 13485:2016-certified facility
  • USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
  • Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products