Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture – PodcastPublished: May 4, 2020
Raw and starting materials: troubleshooting supply, management and optimization issues
Hélène Pora, Vice President Technical Communication & Regulatory Strategy, Pall Biotech
“Gene therapy usually addresses small patient populations, so batch sizes tend to be small and relatively few in number. This is a ‘sweet spot’ for single-use technology.”DOI: 10.18609/cgti.2020.038
Citation: Cell & Gene Therapy Insights 2020; 6(2), 281–287
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Authorship & Conflict of Interest
Contributions: All named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest.
Funding declaration: The author 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 © 2020 Pall Corporation. Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.
Article source: Invited
Podcast recorded: Feb 20 2020; Publication date: Apr 8 2020.
Dr Hélène Pora is Vice President Technical Communication & Regulatory Strategy within Pall Biotech, where she leads technical training and regulatory support improvements. Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. Hélène has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation. She speaks regularly at conferences about single use technology with a strong focus on validation and overall process integration aspects. She is also involved in a different industry interested group with a strong focus on BPOG, and she sits on the board of BPSA.