Virus Inactivation by Heat Treatment of Lyophilized Coagulation Factor Concentrates

2015 ◽  
pp. 44-54 ◽  
Author(s):  
Dennis Piszkiewicz ◽  
William Thomas ◽  
Megumi Y. Lieu ◽  
Daphne Tse ◽  
Linda Sarno
Keyword(s):  
Heat Treatment ◽  
Coagulation Factor ◽  
Virus Inactivation ◽  
Coagulation Factor Concentrates

Effect of Terminal (Dry) Heat Treatment on Non-Enveloped Viruses in Coagulation Factor Concentrates

Vox Sanguinis ◽  
1994 ◽  
Vol 67 (4) ◽  
pp. 345-350 ◽  
Author(s):  
H.F. Hart ◽  
W.G. Hart ◽  
J. Crossley ◽  
A.-M. Perrie ◽  
D.J. Wood ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Coagulation Factor ◽  
Enveloped Viruses ◽  
Dry Heat ◽  
Coagulation Factor Concentrates ◽  
Dry Heat Treatment

Effect of Terminal (Dry) Heat Treatment on Non-Enveloped Viruses in Coagulation Factor Concentrates

Vox Sanguinis ◽  
1994 ◽  
Vol 67 (4) ◽  
pp. 345-350 ◽  
Author(s):  
H.F. (a) Hart ◽  
W.G. (a) Hart ◽  
J. (a) Crossley ◽  
A.-M. (b) Wood ◽  
A. (c) John ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Coagulation Factor ◽  
Enveloped Viruses ◽  
Dry Heat ◽  
Coagulation Factor Concentrates ◽  
Dry Heat Treatment

Measures Taken for Effective Virus Reduction of Plasma-Derived Coagulation Factor Concentrates.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4009-4009
Author(s):  
Albrecht Groener ◽  
Thomas Nowak ◽  
Wolfram Schäfer
Keyword(s):  
Manufacturing Process ◽  
Coagulation Factor ◽  
Virus Genome ◽  
Pathogen Transmission ◽  
Virus Inactivation ◽  
Enveloped Viruses ◽  
Window Period ◽  
Plasma Pool ◽  
Wide Range ◽  
Coagulation Factor Concentrates

Abstract The application of the complementary approaches (i) selection and testing of starting material, (ii) testing the product intermediate at appropriate steps of the production and (iii) assessing the capacity of the production process to reduce a wide range of viruses as well as prions, the causative agent for vCJD, results in plasma-derived coagulation factor concentrates with a remote risk of pathogen transmission. Selecting donors only from low-risk geographic areas considerably reduces the risk of a donation entering the plasma pool for fractionation which harbors either viruses (currently) unknown in the donor population or prions. Use of a sensitive assay to detect virus genome sequences results in the interdiction of contaminants in donations during window periods. Single window period donations with a total virus load of up to 9.9 log10 HAV RNA IU, 6.0 log10 HBV DNA IU, 11.9 log10 HCV RNA IU, 10.9 log10 HIV RNA IU and 16.9 log10 B19V DNA IU are identified and destroyed, and will not enter the plasma pool for fractionation. Plasma pools for fractionation likewise are released for further processing only if non-reactive for serological virus markers and for sequences of virus genome. Thus, potential errors made by not discarding, but pooling window period donations can be precluded, as even one window period donation with a high virus titre would be detected in the plasma pool for fractionation, and the entire plasma pool would be destroyed. A wide range of enveloped and non-enveloped viruses are effectively inactivated by pasteurization (heat treatment at 60°C for 10 hours in stabilized aqueous solution). Additionally, the manufacturing process of plasma-derived coagulation factor concentrates, as the VWF/FVIII product Haemate® P / Humate-P®, contains process steps reliably contributing to the reduction of viruses. As demonstrated in virus validation studies, pasteurization inactivates not only the known blood-borne viruses but also potential “emerging viruses”. Virus Inactivation by Pasteurization of Haemate® P / Humate-P® Virus Inactivation Factor [log10] Complete Virus Inactivation after × hours (1) A/PR/8/34 [H1N1] // A/FPV/Rostock/34 [H7/N1] // A/Chick/Pennsylvania /1/83 [H5N2]; (2) feline calicivirus, model virus for HEV Enveloped viruses HIV > 6.4 1 BVDV // WNV > 6.4 // > 7.8 3 // 2 PRV // HSV-1 4.6 // > 7.7 (10) // 6 SARS-CoV // TGEV > 4.0 // > 5.6 1 // 1 Influenzaviruses (1) > 5.4 // > 4.9 // > 4.9 1 // 2 // 1 Non-enveloped viruses HAV // poliovirus 1 4.2 // > 7.8 (10) // 4 B19V > 3.9 10 FCV (2) > 5.0 1 Furthermore, scaled-down spiking studies demonstrate that the manufacturing process reliably removes deliberately added prions, derived from scrapie-infected hamster brains, by 6.4 log10 for a microsomal preparation and by 7.9 log10 for a purified, non membrane-associated PrPSc preparation. By these measures in the aggregate - selection of donors, testing of individual donations, retesting of plasma pools, implementation of effective pathogen reduction steps in manufacturing - a high margin of safety with regard to viruses and prions can be achieved for plasma-derived coagulation factor concentrates as Haemate® P / Humate-P®. As pasteurization very effectively inactivates a wide range of enveloped and non-enveloped viruses and further manufacturing steps contribute to virus reduction, indirect evidence is provided that the manufacturing procedure will inactivate/remove also other novel or unpredictable virus contamination.

Inactivation of parvovirus B19 during STIM-4 vapor heat treatment of three coagulation factor concentrates

Transfusion ◽  
2008 ◽  
Vol 48 (6) ◽  
pp. 1220-1226 ◽  
Author(s):  
Andreas Berting ◽  
Jens Modrof ◽  
Ulrike Unger ◽  
Matthias Gessner ◽  
Andreas Klotz ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Parvovirus B19 ◽  
Coagulation Factor ◽  
Coagulation Factor Concentrates

“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.

The Year 2020 in Review: Noteworthy Literature for Thoracic Transplant Anesthesiologists

2021 ◽  
pp. 108925322110076
Author(s):  
Benjamin A. Abrams ◽  
Barbara Wilkey
Keyword(s):  
Lung Transplantation ◽  
Adult Congenital Heart Disease ◽  
Coagulation Factor ◽  
Preoperative Assessment ◽  
Total Artificial Heart ◽  
Donor Pool ◽  
Transplant Patients ◽  
Adult Congenital ◽  
Coagulation Factor Concentrates ◽  
Made In

The year 2020 was a monumental year in medicine, and this review focuses on selected articles for cardiothoracic anesthesiologists and perioperative physicians involved in the care of heart and lung transplant patients. In the field of lung transplantation, significant strides were made in our knowledge of risk stratification during the preoperative assessment of potential recipients, perioperative transfusion medicine, and the administration of coagulation factor concentrates. In addition, variations in perioperative management and outcomes between institutions were studied across an assortment of metrics regarding lung transplantation, including case volumes and anesthetic practices. Transitioning to topics in the field of heart transplantation, consideration was given to recipients with adult congenital heart disease, and separately, approaches to expanding the donor pool through donation after circulatory death. With regard to preoperative support, outcomes for the total artificial heart as well as the MitraClip as bridges to transplantation were published.

Sign in / Sign up

Export Citation Format

Share Document