![]() ![]() ![]() The DNA is approximately 4.8 kilobases in size. The viral proteins have molecular weights of approximately 87, 73, and 61 kDa, respectively, totaling 60 monomers arranged in icosahedral symmetry in a ratio of 1:1:10, with an estimated size of 3.9 MDa. Importance of AAV purity & genome integrityĪAV is a small virus with a protein shell, or capsid, comprising three viral protein monomers (VP1, VP2, VP3) that surround a single-stranded DNA. The SCIEX BioPhase 8800 system accelerates analysis and dramatically shortens new therapy development timelines while providing the sensitive, high-resolution data expected in the biopharma industry for bioprocessing to R&D to QA/QC. A new system designed to enable parallel processing of eight samples simultaneously using two well-established capillary electrophoresis (CE) techniques combined with two different detection methods is filling the gap. High-throughput analytical techniques that can overcome these complexities are becoming essential. Existing approaches to detect and characterize product changes during drug development are part of the problem because they take too long. Despite these challenges, developers of gene therapies must be able to understand the molecular liabilities of AAV vectors as soon as possible in the development process in order to ensure the manufacturability of robust, stable molecules prior to clinical trials. From an analytical perspective, samples are getting more complex, more numerous, and require more complex analytical methods that involve complex method set ups, but results are needed in less time. ![]() There are a large number of serotypes to choose from, and the need to implement transfection processes that afford high yields of capsids containing the gene of interest and purification hurdles to overcome. Adeno-associated viral (AAV) vectors, while offering numerous advantages over other viruses (non-pathogenic, low immunogenicity, and can readily enter a variety of cell types), are highly complex molecules that present significant manufacturing challenges. ![]()
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