Reference Materials

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  1. AAV1 Reference Materials (Empty Capsids)
    RS-AAV1-ET
    CMV
  2. AAV1 Reference Materials (full capsids)
    RS-AAV1-FL
    CMV
  3. AAV2 Reference Materials (Empty Capsids)
    RS-AAV2-ET
    CMV
  4. AAV2 Reference Materials (full capsids)
    RS-AAV2-FL
    CMV
  5. AAV5 Reference Materials (Empty Capsids)
    RS-AAV5-ET
    CMV
  6. AAV5 Reference Materials (full capsids)
    RS-AAV5-FL
    CMV
  7. AAV6 Reference Materials (Empty Capsids)
    RS-AAV6-ET
    CMV
  8. AAV6 Reference Materials (full capsids)
    RS-AAV6-FL
    CMV
  9. AAV8 Reference Materials (full capsids)
    RS-AAV8-FL
    CMV
  10. AAV9 Reference Materials (Empty Capsids)
    RS-AAV9-ET
    CMV

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Reference materials are controls or standards for quality control assays and methods. In the field of gene & cell therapy, reference materials are critical for comparability between studies and clinical trials. Previously, the only available AAV reference materials are provided by ATCC over a decade ago. As a leader in AAV production and analytical assays, Vigene is now offering AAV reference materials of full capsids and empty capsids of 6 different serotypes. These well-characterized reference standards are extensively analyzed with molecular based assays and transmission electron microscope.

Commercially supplied reference standards obtained from a reputable commercial source can be used in addition to certified reference standards, according to FDA gene therapy CMC guidance, released in January, 2020, “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)”.