cGMP AAV Assay & QC Services

• Assay development. The data to be collected is identified and the necessary instrumentation, reagents (and/or kits) are selected for a specific assay. The performance parameters are outlined on a preliminary basis.
• Assay optimization. In this phase, a series of experiments are conducted in order to document how various sample and assay conditions affect assay performance. This information will be used to set the acceptance criteria for product phases.
• Assay qualification. The qualification phase is designed to demonstrate that the optimized method provides meaningful data for the specific samples and under the same conditions to be used when the method is fully applied. The protocol is formalized and circulated for review and discussion. Following approval, the protocol is tested and a written report is compiled in which all results, analyses, and conclusions are outlined. The report is then circulated for final approval before the method implementation.
• Assay Validation. The protocol is reviewed under the same procedure as in the qualification phase, but in a more comprehensive manner. The performance of the assay is documented with respect to accuracy, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), specificity/selectivity, precision, and suitability. Validation may include inter-laboratory comparisons as well.

PackGene quality control laboratory
HPLC assay platform for AAV purity and empty shell rate assay