Animal-Free™ Extended Documentation for Ex Vivo Research

Researchers conducting ex vivo studies, such as cell therapy experiments, may require additional documentation to satisfy the requirements of a regulatory body, such as the United States Food and Drug Administration (FDA). The following extended documentation is available detailing the lot-specific characteristics of your shipped product:

  • Certificate of analysis
  • Total amino acid digest analysis
  • N-terminal amino acid analysis
  • Protein Concentration
  • Endotoxin level
  • Microbial testing*
  • Lot-specific bioassay*

*Please note that microbial testing and lot-specific bioassays are conducted at the time the product is bottled and may require increased processing time. Additional third party testing is also available upon request.