[3] A. J. Cann et al., “Reversion to neurovirulence of the live-attenuated sabin type 3 oral
poliovirus vaccine,” Nucleic Acids Res., vol. 12, no. 20, pp. 7787–7792, Oct. 1984.
[4] K. H. Khan, “Gene expression in Mammalian cells and its applications,” Adv.
Pharm. Bull., vol. 3, no. 2, pp. 257–263, 2013.
[5] WHO, “Annex 3 Recommendations for the evaluation of animal cell cultures as
substrates for the manufacture of biological medicinal products and for the char-
acterization of cell banks Replacement of Annex 1 of WHO Technical Report Series,
No. 878,” 2013. https://www.who.int/biologicals/vaccines/TRS_978_Annex_3.pdf
(accessed Oct-2021).
[6] F. Aubrit et al., “Cell substrates for the production of viral vaccines,” Vaccine,
vol. 33, no. 44, pp. 5905–5912, Nov. 2015.
[7] R. I. Freshney, Culture of Animal Cells: A Manual of Basic Technique, 5th Edition.
John Wiley & Sons, Inc.
[8] A. Stokes, “Managing potential virus and TSE contamination | Pharmaceutical en-
gineering March/April,”2018. ( https://ispe.org/pharmaceutical-engineering/march-
april-2018/managing-potential-virus-and-tse-contamination)
[9] P. W. Barone et al., “Viral contamination in biologic manufacture and implications
for emerging therapies,” Nat. Biotechnol. 2020 385, vol. 38, no. 5, pp. 563–572,
Apr. 2020.
[10] D. Onions, C. Côté, B. Love, and J. Kolman, “Deep Sequencing Applications for
Vaccine Development and Safety,” in Vaccine Analysis: Strategies, Principles, and
Control, B. K. Nunnally, V. E. Turula, and R. D. Sitrin, Eds. Berlin, Heidelberg:
Springer-Verlag, 2015, pp. 445–477.
[11] J. Petricciani, R. Sheets, E. Griffiths, and I. Knezevic, “Adventitious agents in viral
vaccines: lessons learned from 4 case studies,” Biologicals, vol. 42, no. 5,
pp. 223–236, Sep. 2014.
[12] J. Victoria et al., “Viral nucleic acids in live-attenuated vaccines: detection of minority
variants and an adventitious virus,” J. Virol., vol. 84, no. 12, pp. 6033–6040, Jun.
2010.
[13] G. Dubin et al., “Investigation of a regulatory agency enquiry into potential porcine
circovirus type 1 contamination of the human rotavirus vaccine, Rotarix: approach and
outcome,” Hum. Vaccine Immunother., vol. 9, no. 11, pp. 2398–2408, Nov. 2013.
[14] R. L. Sheets and P. A. Duncan, “Role of Analytics in Viral Safety,” in Vaccine
Analysis: Strategies, Principles, and Control, B. Nunnally, V. E. Turula, and R.D.
Sitrin, Eds. Berlin, Heidelberg: Springer, 2015.
[15] A. Khan et al., “Advanced Virus Detection Technologies Interest Group
(AVDTIG): Efforts on High Throughput Sequencing (HTS) for virus detection,”
PDA J. Pharm. Sci. Technol., vol. 70, no. 6, pp. 591–595, Nov. 2016.
[16] C. Marcus-Sekura, J. Richardson, R. Harston, N. Sane, and R. Sheets, “Evaluation
of the human host range of bovine and porcine viruses that may contaminate bovine
serum and porcine trypsin used in the manufacture of biological products,”
Biologicals, vol. 39, no. 6, pp. 359–369, Nov. 2011.
[17] L. Gagnieur et al., “Unbiased analysis by high throughput sequencing of the viral
diversity in fetal bovine serum and trypsin used in cell culture,” Biologicals, vol. 42,
no. 3, pp. 145–152, 2014.
[18] ICH, “International conference on harmonisation of technical requirements for re-
gistration of pharmaceuticals for human use ich harmonised tripartite guideline
quality risk management Q9,” 2005. https://database.ich.org/sites/default/files/
Q9%20Guideline.pdf (accessed Oct-2021).
[19] “EDQM (European Directorate for the Quality of Medicines – Council of Europe).
European Pharmacopeia, 9th edition, Strasbourg (France),” 2016.
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