Understanding Adeno-Associated Virus Vector Impurities

Adeno-associated virus (AAV) vectors are rapidly emerging as powerful tools in gene therapy, with the potential to transform treatment for a wide range of diseases. Yet, as these vectors move through clinical development, a key challenge remains: effectively identifying and removing impurities that closely resemble the therapeutic product itself. This includes empty or partially filled capsids that are difficult to separate using current purification methods. The quality and yield of recombinant AAV (rAAV) vectors are heavily influenced by cell line selection and upstream processing strategies. Advances in cell line engineering and the shift to suspension cultures have enabled more scalable production, while downstream purification steps—such as ultrafiltration, capture, and polishing—are being refined to improve impurity removal. For researchers and manufacturers, understanding these process intricacies is essential to ensuring the safety and efficacy of rAAV-based therapies.
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