RU99120190A - A METHOD FOR OBTAINING A GAMMA-GLOBULIN SOLUTION INTENDED FOR INTRAVENOUS INTRODUCTION AND A PRODUCT OBTAINED BY THIS METHOD - Google Patents

A METHOD FOR OBTAINING A GAMMA-GLOBULIN SOLUTION INTENDED FOR INTRAVENOUS INTRODUCTION AND A PRODUCT OBTAINED BY THIS METHOD

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Publication number
RU99120190A
RU99120190A RU99120190/14A RU99120190A RU99120190A RU 99120190 A RU99120190 A RU 99120190A RU 99120190/14 A RU99120190/14 A RU 99120190/14A RU 99120190 A RU99120190 A RU 99120190A RU 99120190 A RU99120190 A RU 99120190A
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RU
Russia
Prior art keywords
gamma globulin
solution
fractionation
organic solvent
stage
Prior art date
Application number
RU99120190/14A
Other languages
Russian (ru)
Other versions
RU2198668C2 (en
Inventor
Раджа Р. МАМИДИ
Андраник БАГДАСАРЯН
Казуо ТЭКЕЧИ
Горгонио КЭНАВЕРЭЛ
Original Assignee
Алфа Терапьютик Корпорейшн
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Application filed by Алфа Терапьютик Корпорейшн filed Critical Алфа Терапьютик Корпорейшн
Publication of RU99120190A publication Critical patent/RU99120190A/en
Application granted granted Critical
Publication of RU2198668C2 publication Critical patent/RU2198668C2/en

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Claims (16)

1. Способ получения раствора гамма-глобулина, предназначенного для внутривенного введения, который включает:
а) тепловую обработку неочищенного раствора гамма-глобулина в течение такого времени и таких температурных условий, которые достаточны для инактивации теплочувствительных вирусов;
б) фракционирование полиэтиленгликолем прошедшего тепловую обработку раствора гамма-глобулина с получением очищенного раствора гамма-глобулина; и
в) обработку очищенного раствора гамма-глобулина органическим растворителем для инактивации оболочечных вирусов.1. A method of obtaining a solution of gamma globulin intended for intravenous administration, which includes:
a) heat treatment of a crude gamma globulin solution for such a time and temperature conditions that are sufficient to inactivate heat sensitive viruses;
b) fractionation of a heat-treated gamma globulin solution with polyethylene glycol to obtain a purified gamma globulin solution; and
c) treating the purified gamma globulin solution with an organic solvent to inactivate enveloped viruses. 2. Способ по п.1, отличающийся тем, что неочищенный раствор гамма-глобулина является фракцией Кона I+II+III, фракцией Кона II+III, фракцией Кона II+IIIw, или фракцией Кона II. 2. The method according to claim 1, characterized in that the crude gamma globulin solution is a Cohn I + II + III fraction, a Cohn II + III fraction, a Cohn II + IIIw fraction, or a Cohn II fraction. 3. Способ по п.1, отличающийся тем, что неочищенный раствор гамма-глобулина подвергают по меньшей мере одному этапу очистки до этапа тепловой обработки (а). 3. The method according to claim 1, characterized in that the crude solution of gamma globulin is subjected to at least one purification step before the heat treatment step (a). 4. Способ по п. 1, отличающийся тем, что этап тепловой обработки (а) осуществляют при температуре 50 - 70oC в течение 10 - 100 ч.4. The method according to p. 1, characterized in that the stage of heat treatment (a) is carried out at a temperature of 50 - 70 o C for 10 - 100 hours 5. Способ по п. 4, отличающийся тем, что этап тепловой обработки (а) осуществляют при температуре около 60oC в течение около 10 ч.5. The method according to p. 4, characterized in that the heat treatment step (a) is carried out at a temperature of about 60 o C for about 10 hours 6. Способ по п.1, отличающийся тем, что фракционирование полиэтиленгликолем осуществляют по меньшей мере в два этапа, при этом примеси удаляют в виде приципитата на первом этапе фракционирования полиэтиленгликолем, а гамма-глобулин выделяют в виде приципитата на втором этапе фракционирования полиэтиленгликолем. 6. The method according to claim 1, characterized in that the fractionation with polyethylene glycol is carried out in at least two stages, the impurities are removed as a precipitate in the first stage of fractionation with polyethylene glycol, and gamma globulin is isolated as a precipitate in the second stage of fractionation with polyethylene glycol. 7. Способ по п.1, отличающийся тем, что органический растворитель, применяемый на этапе (в), является алкилфосфатом. 7. The method according to claim 1, characterized in that the organic solvent used in step (c) is an alkyl phosphate. 8. Способ по п.6, отличающийся тем, что органический растворитель, применяемый на этапе (в), является алкилфосфатом. 8. The method according to claim 6, characterized in that the organic solvent used in step (c) is an alkyl phosphate. 9. Способ по п.8, отличающийся тем, что алкилфосфат является три-n-бутилфосфатом. 9. The method according to claim 8, wherein the alkyl phosphate is tri-n-butyl phosphate. 10. Способ по п.1, отличающийся тем, что органический растворитель содержит детергент. 10. The method according to claim 1, characterized in that the organic solvent contains a detergent. 11. Способ по п.9, отличающийся тем, что органический растворитель содержит детергент. 11. The method according to claim 9, characterized in that the organic solvent contains a detergent. 12. Способ по п.1, отличающийся тем, что после этапа (а) раствор гамма-глобулина обрабатывают анионообменной смолой и катионообменной смолой. 12. The method according to claim 1, characterized in that after step (a) the gamma globulin solution is treated with an anion exchange resin and a cation exchange resin. 13. Способ по п.12, отличающийся тем, что обработка анионообменной смолой предшествует этапу (в), а обработку катионообменной смолой проводят после этапа (в). 13. The method of claim 12, wherein the treatment with an anion exchange resin precedes step (c), and the treatment with cation exchange resin is carried out after step (c). 14. Способ по п.6, отличающийся тем, что этап осветления бентонитом осуществляют после первого этапа фракционирования полиэтиленгликолем. 14. The method according to claim 6, characterized in that the stage of clarification with bentonite is carried out after the first stage of fractionation with polyethylene glycol. 15. Раствор гамма-глобулина, предназначенный для внутривенного введения, полученный способом по п.1. 15. A solution of gamma globulin intended for intravenous administration, obtained by the method according to claim 1. 16. Раствор гамма-глобулина, предназначенный для внутривенного введения, полученный способом по п.13. 16. A solution of gamma globulin intended for intravenous administration, obtained by the method according to item 13.
RU99120190/14A 1997-12-24 1998-12-07 Method of preparing gamma-globulin solution designated for intravenous administration and preparation preparing by this method RU2198668C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US99795297A 1997-12-24 1997-12-24
US08/997,952 1997-12-24

Publications (2)

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RU99120190A true RU99120190A (en) 2001-08-20
RU2198668C2 RU2198668C2 (en) 2003-02-20

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EP (1) EP0971727A4 (en)
JP (1) JP2001514672A (en)
KR (1) KR20000075562A (en)
CN (1) CN1214042C (en)
AR (1) AR018260A1 (en)
AU (1) AU747893B2 (en)
BR (1) BR9807598A (en)
CA (1) CA2281938A1 (en)
CO (1) CO4970799A1 (en)
IL (1) IL131471A0 (en)
MY (1) MY117328A (en)
RU (1) RU2198668C2 (en)
TW (1) TW546144B (en)
UA (1) UA64742C2 (en)
WO (1) WO1999033484A1 (en)

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US6893639B2 (en) 2001-10-19 2005-05-17 Hemacare Corporation Method for high yield purification of immune globulins from blood plasma and blood plasma intermediates
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IL212911A0 (en) * 2011-05-16 2011-07-31 Omrix Biopharmaceuticals Ltd Immunoglobulin reduced in thrombogenic contaminants and preparation thereof
ES2381828B1 (en) * 2012-03-20 2012-11-16 Grifols, S.A. PROCEDURE TO OBTAIN A COMPOSITION OF IgG THROUGH THERMAL TREATMENT
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