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Quality Control Testing, Characterization and Critical Quality Attributes of Adeno‐Associated Virus Vectors Used for Human Gene Therapy
Author(s) -
Wright J. Fraser
Publication year - 2021
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.202000022
Subject(s) - adeno associated virus , good manufacturing practice , genetic enhancement , critical quality attributes , vector (molecular biology) , quality (philosophy) , computer science , process (computing) , product (mathematics) , quality by design , translation (biology) , computational biology , medicine , recombinant dna , new product development , microbiology and biotechnology , biology , gene , business , mathematics , genetics , messenger rna , philosophy , epistemology , geometry , marketing , regulatory affairs , operating system
For adeno‐associated virus (AAV)‐based human gene therapy, challenges for the translation of promising research results to successful clinical development include optimization of vector design and manufacturing processes to ensure that vectors prepared for administration to human subjects have attributes consistent with safe and durable expression. This article briefly reviews quality control methods for routine testing and supplemental characterization of AAV vectors for investigational product development. The relationship of vector and manufacturing process design with product critical quality attributes is discussed.