Applications and Limitations of Equilibrium Density Gradient Analytical Ultracentrifugation for the Quantitative Characterization of Adeno-Associated Virus Vectors-Reference-Cited by-同舟云学术

Applications and Limitations of Equilibrium Density Gradient Analytical Ultracentrifugation for the Quantitative Characterization of Adeno-Associated Virus Vectors

Published:2024-01-02 Issue:2 Volume:96 Page:642-651
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Hirohata Kiichi¹,Yamaguchi Yuki¹^ORCID,Maruno Takahiro¹,Shibuya Risa¹^ORCID,Torisu Tetsuo¹^ORCID,Onishi Takayuki¹,Chono Hideto²,Mineno Junichi²,Yuzhe Yuan³,Higashiyama Kiyoko³,Masumi-Koizumi Kyoko³,Uchida Kazuhisa³,Yamamoto Takenori⁴,Uchida Eriko⁴,Okada Takashi⁵,Uchiyama Susumu¹^ORCID

Affiliation:

1. Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan

2. Takara Bio Inc., 7-4-38 Nojihigashi, Kusatsu, Shiga 525-0058, Japan

3. Graduate School of Science, Technology and Innovation, Kobe University, 1-7-49 Minatojima Minamimachi, Chuo-ku, Kobe 650-0047, Japan

4. Division of Molecular Target and Gene Therapy Products, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki-city, Kanagawa 210-9501, Japan

5. Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo 108-0071, Japan

Funder

Japan Agency for Medical Research and Development

Japan Science and Technology Agency

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.analchem.3c01955

Reference31 articles.

1. Adeno-associated virus vector as a platform for gene therapy delivery

2. Solid Biosciences. Letter to the Duchenne Community: FDA Lifts Clinical Hold on IGNITE DMD Clinical Trial. https://www.solidbio.com/about/media/news/letter-to-the-duchenne-community-fda-lifts-clinical-hold-on-ignite-dmd-clinical-trial.

3. U.S. Department of Health and Human Services Food, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-control-cmc-information-human-gene-therapy-investigational-new-drug.

4. Analytical methods for process and product characterization of recombinant adeno-associated virus-based gene therapies

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