[Viral safety of biologicals].

Annales pharmaceutiques françaises
F Barin

Abstract

The viral safety of biologicals, either human blood derivatives or animal products or recombinant proteins issued from biotechnology, relies on the quality of the starting material, the manufacturing process and, if necessary, the control of the final product. The quality of the starting material is highly guaranteed for blood derivatives due to the individual screening for specific markers (antigens, genome, antibodies) for major blood borne viruses such as hepatitis B and C viruses (HBV, HCV) and human immunodeficiency virus (HIV). It can be reinforced by the detection through amplification procedures (polymerase chain reaction) in the plasma pool of genomes from viruses that have been implicated in contaminations of blood derivatives in the past (parvovirus B19, hepatitis A virus). The association in the manufacturing process of different steps dedicated to purification of plasma proteins (partitioning), virus inactivation (solvent/detergent treatment, heat inactivation) or specific procedures allowing virus removal (nanofiltration) allows to reduce the viral risk very efficiently. The validation studies using scaled down systems and model viruses allow to evaluate the virus safety of any product quantitatively. The aim of t...Continue Reading

References

Jul 1, 1995·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·S M Lemon
Dec 1, 1994·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·B HorowitzC Watklevicz
Aug 1, 1995·International Journal of Epidemiology·Z JohnsonI Temperley
Feb 12, 1998·Biochemical and Biophysical Research Communications·T NishizawaM Mayumi
Sep 4, 1999·The New England Journal of Medicine·E Lawlor, G Columb
May 29, 2000·Science·K B ChuaB W Mahy
Sep 1, 2001·Biochimie·D Spillmann
Oct 19, 2002·Transfusion·Josiane PillonelUNKNOWN Transfusion-Transmissible Agents Working Group of the French Society of Blood Transfusion
Nov 8, 2002·Transfusion·Johannes BlümelAnna Maria Eis-Hübinger
Feb 1, 2003·Haemophilia : the Official Journal of the World Federation of Hemophilia·T Burnouf, M Radosevich
Apr 25, 2003·Lancet·J S M PeirisUNKNOWN SARS study group
Feb 28, 2004·Lancet·J S M PeirisY Guan
Mar 17, 2004·Vox Sanguinis·C MazurierS Chtourou
Jun 2, 2004·Journal of Medical Virology·Fatiha NajioullahPatrice André
Aug 20, 2004·The New England Journal of Medicine·Susan L StramerUNKNOWN National Heart, Lung, and Blood Institute Nucleic Acid Test Study Group
May 11, 2007·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·Arnaud Fontanet
Jun 12, 2010·Progrès en urologie : journal de l'Association française d'urologie et de la Société française d'urologie·P Mouracade

❮ Previous
Next ❯

Citations

May 15, 2013·Biologicals : Journal of the International Association of Biological Standardization·Yordank SánchezElaine Díaz
Feb 16, 2013·Biologicals : Journal of the International Association of Biological Standardization·Clint J WinklerSteven W Herring

❮ Previous
Next ❯

Methods Mentioned

BETA
MDS

Related Concepts

Related Feeds

Bioinformatics in Biomedicine

Bioinformatics in biomedicine incorporates computer science, biology, chemistry, medicine, mathematics and statistics. Discover the latest research on bioinformatics in biomedicine here.

Blood Clotting Disorders

Thrombophilia includes conditions with increased tendency for excessive blood clotting. Blood clotting occurs when the body has insufficient amounts of specialized proteins that make blood clot and stop bleeding. Here is the latest research on blood clotting disorders.