Human Gene Therapy - April 2023 - 272

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REFERENCES
1. U.S. Food and Drug Administration. Approved
Cellular and Gene Therapy Products. Silver Spring,
MD; 2022. Available from: https://www.fda.gov/
vaccines-blood-biologics/cellular-gene-therapy-pro
ducts/approved-cellular-and-gene-therapy-products
[Last accessed: Decembmer 07, 2022].
2. Zhao Z, Anselmo AC, Mitragotri S. Viral vectorbased
gene therapies in the clinic. Bioeng
Transl Med 2021;7(1):e10258; doi: 10.1002/
btm2.10258
3. CEO Council for Growth. Study Projects Future
Workforce Talent Needs for Cell and Gene Therapy
Sector and Benchmarks Connected Health Sector
in Greater Philadelphia. Philadelphia, PA; 2020.
Available from: https://ceocouncilforgrowth.com/
2020/05/study-projects-future-workforce-talentneeds-for-cell-gene-therapy-sector-and-benchmarksconnected-health-sector-in-greater-philadelphia/,
https://www.ncbiotech.org/sites/default/files/inlinefiles/WoW_Report_19-307_LSED_HYPERLINKS_
SINGLEPG.pdf0.Ho,Labiotech.eu/AnitaChakraverty/
April11,2021
[Last accessed: May 13, 2020].
4. Ho LD, Robbins HL, Levine AD. Assessing workforce
needs for the emerging CAR-T cell therapy
industry. Nat Biotechnol 2022;40(2):275-278; doi:
10.1038/s41587-022-01212-6
5. Biomanufacturing Training and Education Center,
Raleigh, NC; 2023. Available from: https://www.
btec.ncsu.edu/ [Last accessed: April 6, 2023].
6. Industry Training. Biomanufacturing Training and
Education Center, Raleigh, NC; 2023. Available from:
https://www.btec.ncsu.edu/industry/index.php [Last
accessed: November 14, 2022].
7. Aslanidi G, Lamb K, Zolotukhin S. An inducible
system for highly efficient production of recombinant
adeno-associated virus (rAAV) vectors in
insect Sf9 cells. PNAS 2009;106(13):5059-5064;
doi: 10.1073/pnas.0810614106
8. Wasilko DJ, Lee SE, Stutzman-Engwall KJ, et al.
The titerless infected-cells preservation and
scale-up (TIPS) method for large-scale production
of NO-sensitive human soluble guanylate cyclase
(sGC) from insect cells infected with recombinant
baculovirus. Protein Expr Purif 2009;65(2):122-
132; doi: 10.1016/j.pep.2009.01.002
9. MilliporeSigma Data Sheet. Millistak+ Pod disposable
depth filter system. Literature number
DS0217EN00, Version 11.0, 2018-10419 02/2019
10. MilliporeSigma Data Sheet. Millistak+ HC Pro
Fully synthetic depth filters for clarification and
downstream filtration applications. Literature
number DS1240EN00, Version 3.0, 2017-08673
12/2017
11. Lutz H. Rationally defined safety factors for filter
sizing. J Membr Sci 2009;341:268-278; doi:
10.1016/j.memsci.2009.06.015
12. 21CFR211.192, Code of Federal Regulations, Title
21-Food and Drugs, Chapter I-Food and Drug
Administration, Department of Health and Human
Services, Subchapter C-Drugs: General. Part 211
Current Good Manufacturing Practice for Finished
Pharmaceuticals, Subpart F-Production and Process
Controls, Sec. 211.103 Calculation of yield.
Available from: https://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=
211&showFR=1 [Last accessed: October 28, 2022].
Received for publication December 15, 2022;
accepted after revision March 1, 2023.
Published online: March 1, 2023.

http://dx.doi.org/10.1038/s41587-022-01212-6 https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products https://www.btec.ncsu.edu/ https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products https://www.btec.ncsu.edu/ http://dx.doi.org/10.1016/j.memsci.2009.06.015 https://www.btec.ncsu.edu/industry/index.php http://dx.doi.org/10.1002/btm2.10258 http://dx.doi.org/10.1002/btm2.10258 https://ceocouncilforgrowth.com/2020/05/study-projects-future-workforce-talent-needs-for-cell-gene-therapy-sector-and-benchmarks-connected-health-sector-in-greater-philadelphia/ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1 https://ceocouncilforgrowth.com/2020/05/study-projects-future-workforce-talent-needs-for-cell-gene-therapy-sector-and-benchmarks-connected-health-sector-in-greater-philadelphia/ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1 https://ceocouncilforgrowth.com/2020/05/study-projects-future-workforce-talent-needs-for-cell-gene-therapy-sector-and-benchmarks-connected-health-sector-in-greater-philadelphia/ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1 https://ceocouncilforgrowth.com/2020/05/study-projects-future-workforce-talent-needs-for-cell-gene-therapy-sector-and-benchmarks-connected-health-sector-in-greater-philadelphia/ https://www.ncbiotech.org/sites/default/files/inline-files/WoW_Report_19-307_LSED_HYPERLINKS_SINGLEPG.pdf0.Ho,Labiotech.eu/AnitaChakraverty/April11,2021 https://www.ncbiotech.org/sites/default/files/inline-files/WoW_Report_19-307_LSED_HYPERLINKS_SINGLEPG.pdf0.Ho,Labiotech.eu/AnitaChakraverty/April11,2021 https://www.ncbiotech.org/sites/default/files/inline-files/WoW_Report_19-307_LSED_HYPERLINKS_SINGLEPG.pdf0.Ho,Labiotech.eu/AnitaChakraverty/April11,2021 http://dx.doi.org/10.1016/j.pep.2009.01.002 https://www.ncbiotech.org/sites/default/files/inline-files/WoW_Report_19-307_LSED_HYPERLINKS_SINGLEPG.pdf0.Ho,Labiotech.eu/AnitaChakraverty/April11,2021

Human Gene Therapy - April 2023

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