The optimization of the downstream process for Adeno-associated virus (AAV) production with consistent quality depends on the ability to characterize critical quality attributes affecting potency, purity and safety of the final product. As the gene therapy field continues to push products through the clinical pipeline, an increasing need for efficient purification and analytical tools has become evident. In addition, the regulatory space has expanded in parallel to the use of AAV, driving the demand for simple and efficient assays to demonstrate product quality and safety.
Read on to learn more about efficient AAV purification tools and characterization steps to consider when manufacturing an AAV drug product.
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2 thoughts on “AAV Downstream Process and Product Characterization: Integrating Advanced Purification and Analytical Tools into the Workflow”
I’d like to know which are CQAs of AAV during purification process.
Very good refenence
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