AAV, exosome quality control and manufacturing process optimization tool
Accurate and efficient evaluation of critical quality attributes using light scattering detectors and LC-MS.
To ensure safe and effective treatment, monitoring of the potency and titer of adeno-associated virus (AAV) vectors, encapsulation, aggregation, genome integrity, and other factors is necessary. By combining SEC (size exclusion chromatography), IEX (ion exchange chromatography), and MALS (multi-angle static light scattering), it is possible to accurately and efficiently evaluate critical quality attributes (CQA) such as the Full/Empty ratio, aggregation, and particle concentration of AAV. RT-MALS allows for real-time measurement of these parameters, which is useful for streamlining the manufacturing process. By combining size separation and light scattering analysis, exosomes can be isolated from other biological components, enabling the detection of new subtypes based on size, composition, charge, and even functional differences, allowing for comprehensive characterization. LC-MS enables the identification and quantification of gene sequences and proteins contained in AAV vectors. By clicking [Submit], you are deemed to have agreed that Waters may use and process the information provided on this site in accordance with Waters' Terms of Use and Privacy Notice. Terms of Use and Privacy Notice www.waters.com/legalandprivacy
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Related Products - Multi-Angle Light Scattering (MALS) Detector DAWN Series - Dynamic and Static Light Scattering Measurement Device DynaPro NanoStar 2 - Light Scattering/Zeta Potential Measurement Device DynaPro ZetaStar - Low Adsorption UPLC System ACQUITY Premier - Column for Gene Therapy Drug Analysis GTxResolve (Column suitable for checking vector fill rate and measuring titers in anion exchange chromatography)
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Applications/Examples of results
Evaluation by SEC-MALS: - Full/Empty of AAV - Detection and identification of impurities such as free proteins and DNA - Aggregate content Evaluation by DLS: - Non-destructive analysis of size distribution, aggregation, and particle concentration in 30 seconds Evaluation by FFF-MALS/DLS: - Separation of different size populations of exosomes (Exo-L, Exo-S, Exomeres) Evaluation by RT-MALS: - Real-time monitoring and quantification of CQA during the manufacturing process to identify impurities Please feel free to contact us if you have any requests for application notes, demo analyses, etc.
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Company information
Waters Corporation, headquartered in Milford, Massachusetts, USA, has played a pioneering role as a specialized manufacturer of liquid chromatography since its establishment in 1958. Actively engaged in the development of new products and technologies, it has grown into an international group company that supplies not only high-performance liquid chromatography but also mass spectrometers (MS) and thermal analysis instruments. Waters Japan started operations in 1973 (Showa 48) as the Japanese base of Waters Corporation. Inheriting the corporate ethos of the U.S. headquarters, we have made "Customer Success" our mission and continue to provide innovative technologies and lab solutions.