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

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

Virus Inactivation by Solvent/Detergent Treatment and the Manufacture of SD-Plasma

Vox Sanguinis ◽  
1998 ◽  
Vol 74 (S1) ◽  
pp. 203-206 ◽  
Author(s):  
B. Horowitz ◽  
A. Lazo ◽  
H. Grossberg ◽  
G. Page ◽  
A. Lippin ◽  
...  
Keyword(s):  
Virus Inactivation ◽  
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.

“In vitro” and in Animal Model Studies on a Double Virus- Inactivated Factor VIII Concentrate

1995 ◽  
Vol 74 (03) ◽  
pp. 868-873 ◽  
Author(s):  
Silvana Arrighi ◽  
Roberta Rossi ◽  
Maria Giuseppina Borri ◽  
Vladimir Lesnikov ◽  
Marina Lesnikov ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Animal Model ◽  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Virus Inactivation ◽  
Enveloped Viruses ◽  
Model Studies ◽  
Heat Treated

SummaryTo improve the safety of plasma derived factor VIII (FVIII) concentrate, we introduced a final super heat treatment (100° C for 30 min) as additional virus inactivation step applied to a lyophilized, highly purified FVIII concentrate (100 IU/mg of proteins) already virus inactivated using the solvent/detergent (SID) method during the manufacturing process.The efficiency of the super heat treatment was demonstrated in inactivating two non-lipid enveloped viruses (Hepatitis A virus and Poliovirus 1). The loss of FVIII procoagulant activity during the super heat treatment was of about 15%, estimated both by clotting and chromogenic assays. No substantial changes were observed in physical, biochemical and immunological characteristics of the heat treated FVIII concentrate in comparison with those of the FVIII before heat treatment.

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