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 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.
Join us in this webinar, where we will take you through the downstream process of AAV purification and the characterization steps associated with process development and their application in manufacturing lot release testing. You will learn more on process analytics and gain more knowledge on the tools that can help simplify the characterization steps of your AAV downstream process.
- An overview of various purification and analytical requirements for AAV production
Efficient downstream solutions for separation and quantification of empty/full capsids
- Proven, sensitive, and rapid molecular methods for detection of mycoplasma and quantitation of residual DNA impurities
- Addressing product safety requirements through effective contribution on viral clearance using affinity chromatography solutions
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