The inherent variability of biological materials brings unique challenges to establishing standards for in vitro model systems and to setting up ISO-compliant processes to produce them. Biological reference materials produced under an ISO Guide 34:2009 accredited process offer confirmed identity, well-defined characteristics and an established chain of custody, all qualities essential to their effectiveness as biological standards in research and development.
ATCC Certified Reference Material is reference material which is homogeneous and stable with respect to one or more specified properties and for which traceability and values of uncertainty at a stated level of confidence are established, where applicable.
The intended uses of ATCC Certified Reference Material are:
- To challenge assay performance; validate or compare test methods; establish sensitivity, linearity and specificity during assay validation or implementation.
- To benchmark critical assay performance during development/validation for regulatory submissions and production lot release.
- For use in testing and calibration in ISO 17025 accredited laboratories.
Certified Reference Materials from ATCC are:
- Traceable to the original seed lot and verified using polyphasic (genotypic and phenotypic) testing to confirm identity.
- Vial is accompanied by a certificate stating property values, expiration date, and proper use; confirming that the necessary procedures have been carried out to ensure their validity and traceability (ISO Guide 30: 1992).
View the list of CRMs that are now available; click here to download the list.
Certificates of Analysis are available electronically, or by hardcopy upon request.