Novel HPLC Applications for Rapid In-process Characterization During AAV Platform Development
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Abstract
Andelyn Biosciences has developed a robust scalable suspension platform for Adeno Associated Virus (AAV) production suitable for all phases. It relies on utilizing a quality-by-design (QbD) approach to ensure both scalability and quality of AAV. Development of in-process analytics for tracking of AAV purity and quality at different stages of production is an integral part of the platform. HPLC can allow for rapid and accurate analysis which are critical to enable fast, robust development cycles. Various HPLC methods will be presented supporting the characterization of in-process AAV development samples. One of the described HPLC methods uses SEC/UV that provides capsid quantitation information in addition to protein impurity profiling. This method can analyze crude up through final samples. In a second method, anion exchange (AEX) chromatography is used to resolve and quantitate empty and full capsids. AEX data at final stages of the suspension process showing the separation of empty and full capsids will be presented. Additionally, process characterization AEX data will be presented that correlate with outsourced AUC data but requiring only a day for data turnaround. Thirdly, multiple in-process impurities are monitored using a single reversed-phase HPLC method. Data that tracks these impurities throughout the downstream purification process will be presented.
Download our ESGCT 2022 Poster
Get exclusive access to our ESGCT 2022 poster! Enter your email to download the poster and stay informed on how we’re pushing the boundaries of cell and gene therapy for a better future.
Abstract
Andelyn Biosciences has developed a robust scalable suspension platform for Adeno Associated Virus (AAV) production suitable for all phases. It relies on utilizing a quality-by-design (QbD) approach to ensure both scalability and quality of AAV. Development of in-process analytics for tracking of AAV purity and quality at different stages of production is an integral part of the platform. HPLC can allow for rapid and accurate analysis which are critical to enable fast, robust development cycles. Various HPLC methods will be presented supporting the characterization of in-process AAV development samples. One of the described HPLC methods uses SEC/UV that provides capsid quantitation information in addition to protein impurity profiling. This method can analyze crude up through final samples. In a second method, anion exchange (AEX) chromatography is used to resolve and quantitate empty and full capsids. AEX data at final stages of the suspension process showing the separation of empty and full capsids will be presented. Additionally, process characterization AEX data will be presented that correlate with outsourced AUC data but requiring only a day for data turnaround. Thirdly, multiple in-process impurities are monitored using a single reversed-phase HPLC method. Data that tracks these impurities throughout the downstream purification process will be presented.
Download our ESGCT 2022 Poster
Get exclusive access to our ESGCT 2022 poster! Enter your email to download the poster and stay informed on how we’re pushing the boundaries of cell and gene therapy for a better future.
Abstract
Andelyn Biosciences has developed a robust scalable suspension platform for Adeno Associated Virus (AAV) production suitable for all phases. It relies on utilizing a quality-by-design (QbD) approach to ensure both scalability and quality of AAV. Development of in-process analytics for tracking of AAV purity and quality at different stages of production is an integral part of the platform. HPLC can allow for rapid and accurate analysis which are critical to enable fast, robust development cycles. Various HPLC methods will be presented supporting the characterization of in-process AAV development samples. One of the described HPLC methods uses SEC/UV that provides capsid quantitation information in addition to protein impurity profiling. This method can analyze crude up through final samples. In a second method, anion exchange (AEX) chromatography is used to resolve and quantitate empty and full capsids. AEX data at final stages of the suspension process showing the separation of empty and full capsids will be presented. Additionally, process characterization AEX data will be presented that correlate with outsourced AUC data but requiring only a day for data turnaround. Thirdly, multiple in-process impurities are monitored using a single reversed-phase HPLC method. Data that tracks these impurities throughout the downstream purification process will be presented.