کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10965371 | 1102746 | 2014 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Reduction of spiked porcine circovirus during the manufacture of a Vero cell-derived vaccine
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کلمات کلیدی
CPEUV-CPPVATCCAdventitious virusTCID50MVMInfluenza - آنفلوانزا Cytopathic effect - اثر سیتوپاتیکUltraviolet-C - اشعه ماوراء بنفش CTrypsin - تریپسینPorcine circovirus - دیرو ویروس گوشت خوکconfidence interval - فاصله اطمینانAmerican Type Culture Collection - مجموعه فرهنگی نوع آمریکاییVaccine - واکسنMinute virus of mice - ویروس موشی از موش هاPorcine parvovirus - پاروویروس گوشتیPCV - پی وی سیTissue Culture Infectious Dose 50% - کشت بافت عفونی 50٪
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Porcine circovirus-1 (PCV1) was recently identified as a contaminant in live Rotavirus vaccines, which was likely caused by contaminated porcine trypsin. The event triggered the development of new regulatory guidance on the use of porcine trypsin which shall ensure that cell lines and porcine trypsin in use are free from PCV1. In addition, manufacturing processes of biologicals other than live vaccines include virus clearance steps that may prevent and mitigate any potential virus contamination of product. In this work, artificial spiking of down-scaled models for the manufacturing process of an inactivated pandemic influenza virus vaccine were used to investigate inactivation of PCV1 and the physico-chemically related porcine parvovirus (PPV) by formalin and ultraviolet-C (UV-C) treatment as well as removal by the purification step sucrose gradient ultracentrifugation. A PCV1 infectivity assay, using a real-time PCR infectivity readout was established. The formalin treatment (0.05% for 48 h) showed substantial inactivation for both PCV1 and PPV with reduction factors of 3.0 log10 and 6.8 log10, respectively, whereas UV-C treatment resulted in complete PPV (â¥5.9 log10) inactivation already at a dose of 13 mJ/cm but merely 1.7 log10 at 24 mJ/cm2 for PCV1. The UV-C inactivation results with PPV were confirmed using minute virus of mice (MVM), indicating that parvoviruses are far more sensitive to UV-C than PCV1. The sucrose density gradient ultracentrifugation also contributed to PCV1 clearance with a reduction factor of 2 log10. The low pH treatment during the production of procine trypsin was investigated and showed effective inactivation for both PCV1 (4.5 log10) and PPV (6.4 log10). In conclusion, PCV1 in general appears to be more resistant to virus inactivation than PPV. Still, the inactivated pandemic influenza vaccine manufacturing process provides for robust virus reduction, in addition to the already implemented testing for PCV1 to avoid any contaminations.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 32, Issue 18, 11 April 2014, Pages 2056-2061
Journal: Vaccine - Volume 32, Issue 18, 11 April 2014, Pages 2056-2061
نویسندگان
Cornelia Lackner, Sandra M. Leydold, Jens Modrof, Maria R. Farcet, Leopold Grillberger, Birgit Schäfer, Heinz Anderle, Thomas R. Kreil,