Applying new technology and approaches to the analytical challenge of assessing the empty full ratio for adeno associated virus
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.
Ian Anderson, "Applying new technology and approaches to the analytical challenge of assessing the empty full ratio for adeno associated virus" in "Advancing Manufacture of Cell and Gene Therapies VII", Sharon Brownlow, Cell & Gene Therapy Catapult, UK; Sean Palecek, University of Wisconsin, USA; Damian Marshall, Achilles Therapeutics, UK; Fernanda Masri, Cell & Gene Therapy Catapult, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/cellgenetherapies_vii/42