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...Biotechnology offers insight into the most common sources, namely 1) raw materials, 2) cell cultures and 3) open operations [3]. Most viral contaminations related to raw materials are associated with...
...right to request Biovian as the controller to erase, for example, outdated information about you. In this case, the data must be erased immediately when there are no longer grounds...
...pressured air-locks for material and personnel entry and exit. The airlocks are composed of two parts (D- and C-grade) and are controlled with inter-locks. HEPA filters are placed across the...
...Granted FDA Fast Track Designation for GT005, an Investigational Gene Therapy for Dry Age-Related Macular Degeneration.https://www.businesswire.com/news/home/20200921005923/en/Gyroscope-Therapeutics-Granted-FDA-Fast-Track-Designation-for-GT005-an-Investigational-Gene-Therapy-for-Dry-Age-Related-Macular-Degeneration%22 [10] Adeno-associated Virus Serotypes: Vector Toolkit for Human Gene Therapy. https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(06)00204-8?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1525001606002048%3Fshowall%3Dtrue [11] In vivo...
...8:45 (CET). TALK: Manufacture and Market for New Biologicals – An overview and deep dive into Viral Vector manufacturing. Click here to see the full agenda: http://www.bioprocessing.se/arrangement/page.xhtml?arrangeSubpage=489 Free registration: http://www.bioprocessing.se/arrangement/page.xhtml?arrangeSubpage=502...
...processes, IT systems to personnel and cleaning. Therefore, adhering to GMP takes more time, costs more, and prohibits spur-of-the-moment changes that might be made in a research laboratory. [1] https://www.elpro.com/fileadmin/elpro-com/lmn/blog_articles/Historic_Events_and_Milestones_in_the_Development_of_GMP.pdf...
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...for gene therapy products,” BioNews, 3 February 2020. [Online]. Available: https://www.bionews.org.uk/page_147567. “FDA Continues Strong Support of Innovation in Development of Gene Therapy Products,” 28 January 2020. [Online]. Available: https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products. Cytiva,...
