Quality Control Testing, Characterization and Critical Quality Attributes of Adeno‐Associated Virus Vectors Used for Human Gene Therapy

Author:

Wright J. Fraser1ORCID

Affiliation:

1. Center for Definitive and Curative Medicine Department of Pediatrics Stanford University School of Medicine Stanford CA 94305 USA

Publisher

Wiley

Subject

Molecular Medicine,Applied Microbiology and Biotechnology,General Medicine

Reference37 articles.

1. Engineering adeno-associated virus vectors for gene therapy

2. Therapeutic in vivo gene transfer for genetic disease using AAV: progress and challenges

3. US Dept Health Human Services Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Guidance for Industry: Analytical procedures and methods validation. Chemistry Manufacturing and Controls Documentation2000.

4. US Dept Health Human Services FDA CDER CBER Guidance for Industry: Q1A (R2) Stability Testing of New Drug Substances and Products2003.

5. US Dept Health Human Services FDA CBER Guidance for FDA and Sponsors: Q8(R2) Pharmaceutical Development2009.

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