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, we are now offering AAV reference materials of full capsids and empty capsids of 6 different serotypes. These well-characterized reference materials 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)”.
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