ГОСТ РИСО 13022—2016
(56] U.S. FDA: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.
Доступно no адресу: dationsforManufacturers/UCM153182.pdf
(57] U.S. FDA: Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene
Therapy Products. 1993-10-14. 58 FR 53248 (Federal Register notice)
(58] 21 CFR 1271: Human Cells. Tissues and Cellular and Tissue-Based Products:
http:i
7www.accessdata.fda.aov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=
1271
(59] Cellular & Gene Therapy Guidances Documents:
http./
/www.fda.aov/BioloaicsBloodVaccines/GuidanceComplianceReaulatorylnformation/Guidances/
CellularandGeneTherapy/default.htm
(60] Vaccines. Blood & Biologies — Tissue & Tissue Products:
http://4vww.fda.aov/BioloaicsBloodVaccines/TissueTissueProducts/default.htm
(61] Wessman. S.J. Vaccine cell substrates: bovine and porcine virus considerations. Dev Biol (Basel). 2006: 123:
pp. 273— 280
(62] Robertson J.S. Bovine serum — regulatory issues. Dev Biol (Basel). 2006: 123: pp. 269— 279
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