A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/139
A61K 39/395 (2006.01) A61L 2/00 (2006.01) A61L 2/04 (2006.01) C07K 16/06 (2006.01) A61K 38/00 (2006.01)
Patent
CA 1312546
Invention: PREPARATION OF RETROVIRUS-FREE IMMUNOGLOBULINS Inventors: GAUTAM MITRA and MILTON M. MOZEN Abstract of The Disclosure The effects of Cohn-Oncley cold alcohol fractionation on infectivity of two prototype retroviruses, mouse xenotropic type C and the LAV strain of AIDS retrovirus result in a significant reduction in retrovirus titer. At least a 100,000-fold reduction of LAV was obtained when fraction- ating plasma to fraction II. Adjustment to pH 4.0 at filtrate III was as effective for viral inactivation as was precipitation of fraction II from filtrate III with 25% ethanol. Liquid immunoglobulin preparations spiked with LAV and incubated at 27° C for 3 days resulted in an additional 1,000 - 10,000-fold reduction of LAV titer. Our results support the clinical and epidemiological evidence that therapeutic immunoglobulin preparations prepared by Cohn-Oncley cold ethanol processing (at least about 18% v/v alcohol, pH ? 5.4) and then stored at a pH equal to or less than about 5.4 and a temperature of at least 27° C for at least 3 days, do not transmit retroviruses such as the LAV strain of the AIDS virus. Similar fractionation followed by storage at a higher pH (6.8) followed by a storage at a higher temperature (45° C) for at least B hours also appears effective in avoiding transmission of the retroviruses. CL-128
534100
Mitra Gautam
Mozen Milton M.
Miles Inc.
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
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