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Items: 1 to 20 of 155

1.

Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products.

Gombold J, Karakasidis S, Niksa P, Podczasy J, Neumann K, Richardson J, Sane N, Johnson-Leva R, Randolph V, Sadoff J, Minor P, Schmidt A, Duncan P, Sheets RL.

Vaccine. 2014 May 19;32(24):2916-26. doi: 10.1016/j.vaccine.2014.02.021. Epub 2014 Mar 25.

2.

Evolution of approaches to viral safety issues for biological products.

Lubiniecki AS.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):547-56. doi: 10.5731/pdajpst.2011.00818.

PMID:
22294576
3.

Current testing methods and challenges for detection of adventitious viruses.

Khan AS.

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):627-33. doi: 10.5731/pdajpst.2011.00831.

PMID:
22294589
4.

Issues of biological assays for viral vaccines.

Lee CK.

Dev Biol Stand. 1996;88:41-7. Review.

PMID:
9119161
5.

Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing.

Mee ET, Preston MD, Minor PD, Schepelmann S; CS533 Study Participants.

Vaccine. 2016 Apr 12;34(17):2035-43. doi: 10.1016/j.vaccine.2015.12.020. Epub 2015 Dec 19.

6.

Detection of adventitious viruses in biologicals--a rare occurrence.

Nims RW.

Dev Biol (Basel). 2006;123:153-64; discussion 183-97.

PMID:
16566443
7.

Current issues in viral assays and viral clearance evaluation.

Lubiniecki AS.

Dev Biol Stand. 1996;88:9-11.

PMID:
9119167
8.

Evaluation of cells and biological reagents for adventitious agents using degenerate primer PCR and massively parallel sequencing.

McClenahan SD, Uhlenhaut C, Krause PR.

Vaccine. 2014 Dec 12;32(52):7115-21. doi: 10.1016/j.vaccine.2014.10.022. Epub 2014 Oct 27.

PMID:
25454874
9.

[Viral safety of biological medicinal products].

Stühler A, Blümel J.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Oct;57(10):1198-202. doi: 10.1007/s00103-014-2030-4. German.

PMID:
25123140
10.

Process changes and their effect on process evaluation for viral clearance.

Marcus-Sekura C.

Dev Biol Stand. 1996;88:125-30. Review.

PMID:
9119123
11.

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.

Marcus-Sekura C, Richardson JC, Harston RK, Sane N, Sheets RL.

Biologicals. 2011 Nov;39(6):359-69. doi: 10.1016/j.biologicals.2011.08.003. Epub 2011 Oct 13. Review.

12.

Viral safety of biological products and the concept of validation.

Horaud F.

Dev Biol Stand. 1996;88:19-24. Review. No abstract available.

PMID:
9119135
13.

Use of PCR for extranous agent testing in avian vaccines.

Ottiger HP.

Dev Biol (Basel). 2002;111:23-6.

PMID:
12678221
14.

Safety of biological products prepared from mammalian cell culture. In-process testing for viral agents.

[No authors listed]

Dev Biol Stand. 1998;93:130-1. Review. No abstract available.

PMID:
9737389
15.

Scope and practicality of in vivo testing for adventitious agents.

Whiteman MD.

Dev Biol (Basel). 2006;123:147-52; discussion 183-97. Review.

PMID:
16566442
16.

Adventitious agents in viral vaccines: lessons learned from 4 case studies.

Petricciani J, Sheets R, Griffiths E, Knezevic I.

Biologicals. 2014 Sep;42(5):223-36. doi: 10.1016/j.biologicals.2014.07.003. Epub 2014 Aug 16. Review.

17.

Risk reduction in biotherapeutic products.

Ill CR, Dehghani H.

Curr Opin Drug Discov Devel. 2009 Mar;12(2):296-304. Review.

PMID:
19333875
18.

Process scale considerations in evaluation studies and scale-up.

Walter JK, Werz W, Berthold W.

Dev Biol Stand. 1996;88:99-108. Review.

PMID:
9119169
19.

Methods to select suitable fetal bovine serum for use in quality control assays for the detection of adventitious viruses from biological products.

Kozasa T, Aoki H, Nakajima N, Fukusho A, Ishimaru M, Nakamura S.

Biologicals. 2011 Jul;39(4):242-8. doi: 10.1016/j.biologicals.2011.06.001. Epub 2011 Jun 30.

PMID:
21719306
20.

Molecular methods for virus discovery.

Jarrett RF, Johnson D, Wilson KS, Gallagher A.

Dev Biol (Basel). 2006;123:77-88; discussion 119-32.

PMID:
16566437

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