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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,...
...gene therapies. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics [2] Rare Disease Information. https://rarediseases.org/for-patients-and-families/information-resources/rare-disease-information/ [3] FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-gene-therapy-treat-patients-rare-form-inherited-vision-loss#:~:text=FDA%20News%20Release-,FDA%20approves%20novel%20gene%20therapy%20to%20treat%20patients%20with,form%20of%20inherited%20vision%20loss&text=The%20U.S.%20Food%20and%20Drug,that%20may%20result%20in%20blindness. [4] Gene Therapy for...
...that have contaminated glucose. Since a human-derived cell line, HEK293, is used, human hepatitis A, HAV (~27-32nm, ssRNA, non-enveloped virus) and herpes simplex virus 1, HSV-1, (~ 155-200nm, dsDNA, enveloped...
...quality agreements. Stability study capabilities (for Drug Substances, Drug Products and buffers): Controlled cabinets for stability studies – Storage conditions according to ICH guidelines -70°C / -20°C / +5°C /...
...with e.g. the standard operating procedures (SOPs), laboratory activities such as cell culture, and practicalities related to the AAV projects. “People were clear and thorough when sharing information. I appreciate...
...[1] Net Promoter Score Definition. https://www.medallia.com/net-promoter-score/#:~:text=The%20Net%20Promoter%20Score%20is,customer’s%20loyalty%20to%20the%20brand. [2] What Do Companies with High Net Promoter Score Have in Common? https://www.retently.com/blog/companies-high-nps/ [3] What is Net Promoter Score®? Your introduction to NPS. https://www.hotjar.com/net-promoter-score/#:~:text=Net%20Promoter%20Score%20(NPS)%20is,to%20the%20story%20than%20that....
...subsequent Drug Product batches manufactured, including cell banks. Soluble and insoluble processes. Cell line capabilities: E.coli, P.pastoris and other. All clinical phases – Phase I to Phase III. https://youtu.be/wchrSrGU898 Track...
