By T.R. Flotte, and K.I. Berns (Eds.)
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Under laboratory conditions to determine the vector’s safety. Safety studies for AAV vectors include acute and long‐term toxicology, and biodistribution of vector in appropriate animal models. Other safety studies may be required. , or studies to determine the vector’s physical or chemical characteristics do not need to be performed in a manner compliant with GLP regulations. GLP compliance ensures the quality and acceptability of the safety data generated in these studies. Characterization of the vector batch used in non‐clinical safety studies is also performed in compliance with GLPs.
Virol. 73, 1309–1319. Chiorini, J. , Safer, B. and Kotin, R. M. (1997). Cloning of adeno‐associated virus type 4 (AAV4) and generation of recombinant AAV4 particles. J. Virol. 71, 6823–6833. Chiorini, J. A. et al. (1998). Inhibition of PrKX, a novel protein kinase, and the cyclic AMP‐dependent protein kinase PKA by the regulatory proteins of adeno‐associated virus type 2. Mol. Cell. Biol. 18, 5921–5929. Clark, K. , McGrath, J. P. and Johnson, P. R. (1999). Highly purified recombinant adeno‐associated virus vectors are biologically active and free of detectable helper and wild‐type viruses [In Process Citation].
To meet these requirements, an appropriate process needs to be developed. 1. Technology transfer The manufacture of clinical‐grade rAAV vectors requires the development of a process that will provide an adequate number of safe doses of vector for the trial itself as well as for release testing and for the examination of the vector product’s stability in the final formulation over time. Most research‐level processes would not meet this requirement. During the development of the clinical‐ grade process, it is important to consider many factors including scale, vector yield, product purity, process impurities, sampling procedures, and final product formulation.