Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers-Reference-Cited by-同舟云学术

Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers

Published:2020-08-19 Issue:11 Volume:60 Page:2661-2674
ISSN:0041-1132
Container-title:Transfusion
language:en
Short-container-title:Transfusion

Author:

Roth Nathan J.¹,Dichtelmüller Herbert O.²,Fabbrizzi Fabrizio³,Flechsig Eckhard²,Gröner Albrecht⁴,Gustafson Mary⁵,Jorquera Juan I.⁶,Kreil Thomas R.⁷,Misztela Dominika⁸^ORCID,Moretti Elisa³,Moscardini Mila³,Poelsler Gerhard²,More John⁹,Roberts Peter⁹,Wieser Andreas⁷,Gajardo Rodrigo⁶

Affiliation:

1. CSL Behring Bern Switzerland

2. Biotest Dreieich Germany

3. Kedrion Castelvecchio Pascoli Italy

4. CSL Behring Marburg Germany

5. PPTA Annapolis Maryland USA

6. Grifols Sant Cugat del Vallès Spain

7. Takeda Vienna Austria

8. PPTA Brussels Belgium

9. BioProducts Laboratory Elstree UK

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/trf.16022

Reference57 articles.

1. EMA/CHMP Guideline: Guideline on Plasma‐derived Medicinal Products. EMA/CHMP/BWP/706271/2010. Amsterdam: European Medicines Agency (EMA); 2011 Jul 21.

2. CFR ‐ Code of Federal Regulations Title 21—Food and Drugs Chapter I—Food and Drug Administration Department of Health and Human Services Subchapter F—Biologics Part 640 Additional Standards for Human Blood and Blood Products. Silver Spring MD: U.S. Food and Drug Administration; last updated 2019 Sep 19. Accessed November 20 2019.

3. International Quality Plasma Program (IQPP). PPTA Web site.http://www.pptaglobal.org/safety-quality/standards/iqpp. c2020 2019.

4. Virus safety of plasma products using 20 nm instead of 15 nm filtration as virus removing step

5. Tolerability and safety of the intravenous immunoglobulin Octagam®: a 10-year prospective observational study

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