Navigating Analytical Requirements For GMP Viral Vectors

The analytical requirements for viral vectors used to deliver gene therapies are complex and constantly evolving. The keys to success, in addition to the necessary extensive experience in analytical development for viral vectors, is establishing appropriate strategies beginning with fundamental testing, expecting additional regulatory requests, being prepared for assay variability, recognizing the limits of current understanding, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.

Many Analytical Development Challenges

The cell and gene therapy field is evolving rapidly, and, as the understanding of optimal approaches to cell and gene therapy expands and viral vector engineering advances, the supporting analytics must be modified and, in some cases, new techniques and methods must be developed.