Addressing Key Attributes of Viral Vectors

Adeno-associated viruses (AAVs) are the most commonly used type of viral vector applied in gene therapy trials to date (1). From a regulatory perspective, an understanding of the critical quality attributes (CQAs) that impact product safety, purity, and potency is required. Specific analytical assays to assess vector productivity, vector purity, biological activity, and safety are required to generate data to ensure that the vector is produced with the consistency necessary to ensure safety and prevent undesired affects (2) on patients’ health while maximizing clinical benefit.

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References
1 Ginn SL, et al. Gene Therapy Clinical Trials Worldwide to 2017: An Update. J. Gene Med. 20, 2018: e3015.
2 Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications, Draft Guidance for Industry. Food and Drug Administration: Silver Spring, MD, 2018.