Regulatory requirements and product attributes for cGMP viral vector production
Cell & Gene Therapy Insights 2022; 8(11), 1353
DOI: 10.18609/cgti.2022.196
Navigating the constantly evolving regulatory landscape in cell and gene therapy manufacturing can pose critical challenges for developers and manufacturers. Failure to meet requirements can significantly raise costs, motivating the implementation of robust, reproducible, and compliant processes.
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Authorship & Conflict of Interest
Contributions: The named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Acknowledgements: None
Disclosure and potential conflicts of interest: Cross S discloses he receives consulting fees and has stocks/stock options from Dark Horse Consulting Group. Mishra S discloses she has stocks in ThermoFisher Scientific.
Funding declaration: The authors received no financial support for the research, authorship and/or publication of this article.
Article & copyright information
Copyright: Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.
Attribution: Copyright © 2022 Thermo Fisher Scientific. Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.
Article source: From a Live30 Webinar recorded on Oct 20 2022; Publication date: Dec 19 2022.