Enveloped Virus Inactivation by Caprylate: A Robust Alternative to Solvent-Detergent Treatment in Plasma Derived Intermediates

Biologicals ◽  
2002 ◽  
Vol 30 (2) ◽  
pp. 153-162 ◽  
Author(s):  
M. Korneyeva ◽  
J. Hotta ◽  
W. Lebing ◽  
R.S. Rosenthal ◽  
L. Franks ◽  
...  
Keyword(s):  
Virus Inactivation ◽  
Enveloped Virus ◽  
Detergent Treatment

Optimization of non-detergent treatment for enveloped virus inactivation using the Taguchi design of experimental methodology (DOE)

2019 ◽  
Vol 49 (7) ◽  
pp. 686-694
Author(s):  
Roya Khosravi ◽  
Seyed Nezamedin Hosseini ◽  
Amin Javidanbardan ◽  
Maryam Khatami ◽  
Hooman Kaghazian ◽  
...  
Keyword(s):  
Taguchi Design ◽  
Experimental Methodology ◽  
Virus Inactivation ◽  
Enveloped Virus ◽  
Detergent Treatment

UV-C Treatment Of Intermediates Of Biologicals To Inactivate Viruses Without Denaturing Desired Protein

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4822-4822
Author(s):  
Albrecht Groener ◽  
Christine Dreier
Keyword(s):  
Virus Inactivation ◽  
Dependent Manner ◽  
Enveloped Virus ◽  
Physico Chemical ◽  
Sartorius Stedim Biotech ◽  
Wide Range ◽  
Reduction Methods ◽  
Detergent Treatment ◽  
The Impact ◽  
Uv C

Dedicated virus reduction steps implemented in the manufacturing process of biologicals, either isolated from human plasma or produced as recombinant proteins, are essential safety measures to assure that a potential virus contamination of the source material will not be transmitted to patients requiring these therapeutic proteins. Currently applied virus reduction steps as solvent/detergent treatment and virus filtration are very effective virus reduction methods with inherent method-dependent gaps regarding the reduction capacity for a very wide range of viruses of diverse physico-chemical characteristics: solvent/detergent treatment does not inactivate non-enveloped viruses and, depending on the pore size of the virus filter, small viruses are not removed when the desired protein is large and has to pass the filter. Therefore, another virus inactivation method was studied which is considered especially effective for small viruses: UV-C treatment using the UVivatec system provided by Sartorius Stedim Biotech GmbH, Göttingen, Germany. Experiments were performed to study the impact of UV-C treatment on the integrity of proteins employing fibrinogen as an example for a large protein and on the inactivation capacity for poliovirus (a small non-enveloped virus). The integrity of fibrinogen was assessed by comparing the untreated fibrinogen with the UV-C treated fibrinogen using HPLC, Clauss assay and thromboelastometry. Virus inactivation was studied in a bioassay using a sensitive cell culture infectivity assay employing a cynomolgus cell line. The results show that UV-C treatment inactivates viruses and modifies fibrinogen in a dose dependent manner; the monomer, dimer and polymer peak in the fibrinogen preparation studied changed from approx. 75% to 60%, 17% to 25% and 8% to 13%, respectively, at a UV-C intensity of 400 J/m² demonstrated by HPLC measurement. In order to protect fibrinogen from modifications, the antioxidant glutathione was added to the fibrinogen preparation. At an UV-C intensity of approx. 300 J/m², sufficient to effectively inactivate viruses studied, a modification of fibrinogen was not any longer detectable. Disclosures: Groener: CSL Behring: Employment.

Enveloped virus inactivation using neutral arginine solutions and applications in therapeutic protein purification processes

2013 ◽  
Vol 30 (1) ◽  
pp. 108-112 ◽  
Author(s):  
Justin T. McCue ◽  
Keith Selvitelli ◽  
Doug Cecchini ◽  
Rhonda Brown
Keyword(s):  
Protein Purification ◽  
Therapeutic Protein ◽  
Virus Inactivation ◽  
Enveloped Virus

Strategies for Evaluation of Enveloped Virus Inactivation in Red Cell Concentrates Using Hypericin

2000 ◽  
Vol 71 (2) ◽  
pp. 188-195 ◽  
Author(s):  
Alfred M. Prince ◽  
Donna Pascual ◽  
Daniel Meruelo ◽  
Leonard Liebes ◽  
Yehuda Mazur ◽  
...  
Keyword(s):  
Virus Inactivation ◽  
Red Cell ◽  
Enveloped Virus

scholarly journals Mechanisms of Methods for Hepatitis C Virus Inactivation

2014 ◽  
Vol 81 (5) ◽  
pp. 1616-1621 ◽  
Author(s):  
Stephanie Pfaender ◽  
Janine Brinkmann ◽  
Daniel Todt ◽  
Nina Riebesehl ◽  
Joerg Steinmann ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Infection Control ◽  
Viral Envelope ◽  
Enzyme Linked Immunosorbent Assay ◽  
Virus Inactivation ◽  
Protection Assay ◽  
Uv Treatment ◽  
Enveloped Viruses ◽  
Enveloped Virus

ABSTRACTVirus inactivation by chemical disinfectants is an important instrument for infection control in medical settings, but the mechanisms involved are poorly understood. In this study, we systematically investigated the effects of several antiviral treatments on hepatitis C virus (HCV) particles as model for enveloped viruses. Studies were performed with authentic cell culture-derived viruses, and the influence of chemical disinfectants, heat, and UV treatment on HCV was analyzed by the determination of infectious particles in a limiting-dilution assay, by quantitative reverse transcription-PCR, by core enzyme-linked immunosorbent assay, and by proteolytic protection assay. All different inactivation methods resulted in a loss of HCV infectivity by targeting different parts of the virus particle. Alcohols such as ethanol and 2-propanol did not affect the viral RNA genome integrity but disrupted the viral envelope membrane in a capsid protection assay. Heat and UV treatment of HCV particles resulted in direct damage of the viral genome since transfection of viral particle-associated RNA into permissive cells did not initiate RNA replication. In addition, heat incubation at 80°C disrupted the HCV envelope, rendering the viral capsid susceptible to proteolytic digest. This study demonstrated the molecular processes of viral inactivation of an enveloped virus and should facilitate the development of effective disinfection strategies in infection control not only against HCV but also against other enveloped viruses.

Comparable Virus Inactivation by Bovine or Vegetable Derived Tween 80 During Solvent/Detergent Treatment

Biologicals ◽  
2002 ◽  
Vol 30 (3) ◽  
pp. 197-205 ◽  
Author(s):  
Holger Seitz ◽  
Johannes Blümel ◽  
Ivo Schmidt ◽  
Hannelore Willkommen ◽  
Johannes Löwer
Keyword(s):  
Tween 80 ◽  
Virus Inactivation ◽  
Detergent Treatment

TREATMENT OF PLASMA DERIVATIVES WITH UNSATURATED FATTY ACIDS TO INACTIVATE VIRUSES

1987 ◽  
Author(s):  
B Horowitz ◽  
M Piët ◽  
A M Prince
Keyword(s):  
Fatty Acids ◽  
Protein Function ◽  
Sindbis Virus ◽  
Unsaturated Fatty Acids ◽  
Butylated Hydroxytoluene ◽  
Virus Inactivation ◽  
Enveloped Virus ◽  
Complete Inactivation ◽  
Sample Composition ◽  
Arachidonic Acids

Virus sterilization of blood plasma derivatives by addition of several naturally occurring fatty acids was evaluated using VSV and Sindbis virus as markers for lipid enveloped virus inactivation. Complete inactivation >4 log10) of virus added to an AHF concentrate with 60-101)% retention of AHF activity was achieved with oleic, 11-eicosenoic, linoleic, linolenic, palmitoleic and arachidonic acids. Elaidic, gamma-linolenic, palmitic, and arachidic acids. Another fat-soluble compound previously reported to inactivate virus, butylated hydroxytoluene, was less effective. A long chain mono- but not a di- or tri-glyceride also displayed virucidal properties.The degree of virus inactivation depended on the sample composition. A favorable balance was achieved between degree of virus inactivation and retention of protein function for AHF concentrate, prothrombin complex concentrate, antithrombin-III concentrate, and immune globulin solution on incubation with 0.033% (w/v) sodium oleateat 24°C for 4-6 hours. Virus inactivation in whole plasma and plasma cryoprecipitate was not complete despite use of higher concentrations of sodiumleate and/or incubation at 37°C.Utilization of fatty acids for thepreparation of blood derivatives has the advantage that they are naturallyoccurring and have low toxicity, thussimplifying the production process. This simplicity encourages the sequential use of fatty acids with other procedures designed to inactivate or remove viruses and which operate by a distinct mechanism.

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