A Device for Inactivation of Viruses in Albumin Solution by Heat Treatment
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A Device for Inactivation of Viruses in Albumin Solution by Heat Treatment A. G. Gudkov1,2*, V. Yu. Leushin2, I. A. Sidorov1, V. N. Lemondzhava2, M. I. Lazarenko3, A. V. Chechetkin4, V. V. Danilchenko4, S. V. Chizhikov1, and G. A. Gudkov2
A new approach to the problem of ensuring the accuracy of the process of heat treatment of albumin solution is described. The results of experimental studies confirming the effectiveness of the developed device for the inacti vation of viruses in blood products are presented.
Introduction Plasma quarantine and pathogen inactivation meth ods are used, along with the mandatory laboratory testing of donated blood for markers of bloodborne infections, to ensure the viral safety of blood components (in partic ular, blood plasma). Plasma quarantine is an effective method for ensuring the safety of donor plasma. However, its implementation involves complex organizational deci sions; technical errors are also possible [13]. The goal of this work was to study the technological process of virus inactivation by thermal denaturation. This process is applicable to albumin produced as a con centrated solution with stabilizers (sodium caprylate and Nacetyl tryptophan) added to prevent protein denatura tion. Vials with such solutions are heated to 60°C and incubated for at least 10 hours at 60 ± 1°C. This inactiva tion technique is not specific for individual viruses, so there is no need to carry out specific procedures for each known pathogen. However, effective application of this method has its limitations due to a compromise between the ability to destroy the virus and the need to avoid excessive protein denaturation [13].
1
Bauman Moscow State Technical University, Moscow, Russia. Hyperion Ltd., Moscow, Russia; Email: [email protected] 3 City Clinical Hospital No. 1 named after N. I. Pirogov, Moscow, Russia. 4 Russian Research Institute of Hematology and Blood Transfusion of the Federal MedicalBiological Agency, St. Petersburg, Russia. * To whom correspondence should be addressed. 2
A study of the international demand for albumin solutions in 20002016 conducted by an independent research company (Marketing Research Bureau, Inc.) showed an aggregate average annual growth rate of 4.8%. A method providing the required accuracy of heat treat ment processes implemented by virus inactivation devices with tanks of various volumes has been previously devel oped and tested by our team [310]. When developing a new device with a tank larger (700 L) than those used in the previous devices, the task was to increase its applica bility by adapting the technological process to three types of vials. The development of such a device required a new approach to the problem of ensuring the accuracy of the heat treatment of albumin solutions. In this work, the results of calculation of the technical characteristics of the device are presented. Previously developed principles and methods of comprehensive technological optimization of electronic devices [1113] and techniques for modelin
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