Applying new technology and approaches to the analytical challenge of assessing the empty full ratio for adeno associated virus

Conference Dates

February 6 – 10, 2022


Abstract: Assessing the empty full ratio for Adeno associated virus (AAV) is a key critical quality attribute. It needs to be done both in-process and at the Drug Substance/Drug Product release phase of manufacturing. Measuring the ratio at different phases of the processes offers up different challenges. I will be focusing on in my talk how we have been using new technology to gain more empty full ratio information from less in-process material and using automation to increase throughput. I will also focus on how we have been using new software with older technology in the use of Analytical ultra-centrifugation as the release test for the empty full ratio measurement with Ultrascan software. This solution is 21CFR part 11 compliant and allows for a multi wavelength scan which gives unrivalled information on AAV DNA load packaging.

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