Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
  • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
  • A61L2/0023—Heat
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/04—Heat
• • C—CHEMISTRY; METALLURGY
  • C07—ORGANIC CHEMISTRY
  • C07K—PEPTIDES
  • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
  • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
  • C07K16/065—Purification, fragmentation

Definitions

• immunoglobulin gammaglobulin
• immunoglobulin immunoglobulin
• gammaglobulin immunoglobulin
• immunoglobulin serum globulin
• can and do transmit non-A, non- B hepatitis see Welch, A.G. et al Non-A, Non-B hepatitis from intravenous immunoglobulin. Lancet 1983 , pp. 1198-99; also see Lane, R.S.: Non-A, non-B hepatitis from intravenous immunoglobulin. Lancet 1983; 2:975-5 ⁇ also: Lever, A.L.
• the object of the present invention to demonstrate a method to substantially inactivate any microorganism or virus which may be present in immunologlobulin preparation. This is accomplished by using the method of lyoprrlizafcion (freeze-drying) that is the immunoglobulin preparation is lyophilized and thereafter is subjected to a heat treatment at various temperatures for various times while in the lyophilized state in order to inactivate any viruses especially non-A, non-B hepatitis and the agent causing AIDS (HTLV-III virus).
• lyoprrlizafcion freeze-drying
• Linear regression analysis is a statistical tool which is employed to determine how closely two analytical techniques will reproduce the same value.
• the values for one technique When the values for one technique are plotted against the values for the second technique, they will align themselves around a straight line, which is at a 45 degree angle to the x-axis.
• This y-intercept provides an estimate of the constant difference or bias between the two methods. The larger the derivation of the y-intercept from 0, in either a positive or negative direction, the greater is the constant difference between the two methods. This difference is expressed in terms of absolute concentration units.
• the correlation coefficient, or r is a unitless quantity which is a measure of random error. On the graphical plot, this is observed as the relative scatter of values around the regression line. While this is the most commonly employed tool for evaluating how well two methods compare, this statistic must be interpreted with care. It is sensitive only to random error and does not reflect constant or proportional bias. Additionally, the correlation coefficient is strongly dependent upon the range of values of the sample populations being compared. Wnen setting up a correlation study, a broad range of values is generally more important than the number of values being evaluated. When interpreting the r value, the closer the value is to unity, generally, the more closely the two methods correlate. However, two methods can show excellent 4 values, e.g. 0.95 or better, yet have considerable proportional error due to differences in calibration. Additionally, the methods under consideration could possess considerable differences in antibody specificity, show a y-intercept deviating greatly from zero, yet have excellent coefficients, of: correlation.
• Linearity of the Immunochemistry System is verified throughout the entire normal measuring range or dilution. It follows that linearity of the assay extends throughout the remaining dilutions. Sample concentrations that lie outside of the normal measuring range are repeated using a higher or lower dilution so that antigen concentrations within the final reaction mixture are always being analyzed in a range of values known to yield a linear response. In evaluating the results of a regression analysis, should either method be non-linear at either the high or low ends of its measuring range, a false deviation in proportional error will be observed. Since the slope of the regression line is affected, subsequent error in the y-intercept may also be observed.
• the Beckman Immunochemistry System that was used combines rate nephelometry with microprocessor technology to provide a method for monitoring the immunopreipitin reactions that are used for specific protein determinations.
• the maximum rate of increase in forward light scatter is measured after a monospecific antisera is added to a polymeric buffer solution containing the diluted patent sample.
• the agarose card was readied and then the well was filled with 0.6 Lambda specimen and then was run for thirty-five minutes, then was put in Amido Black for fifteen minutes, then was rocked gently in old acetic acid for thirty seconds, then put in the oven for twenty minutes, then cooled for one minute on towel, and was rocked gently again in old acetic acid for one minute, and was rocked gently in new acetic acid for one minute (solution should be clear) then was put in oven for ten minutes or until dry, then scanned. (This method was currently being used at the L.A. County-U.S.C. Medical Center, Los Angeles , California . ) The results of the serum protein electropheresis are shown in Figure II.
• Immune Globulin gammaglobulin
• Immunoglobulin gammaglobulin
• Immune Globulin is used to treat immune deficiency such as combined immune deficiency and in primary immunoglobulin deficiency syndrome such as X-linked agammaglobulluremes.
• IV administered immunoglobulin has also been used for treatment of idiopathic thrombocytopemes purpera (ITP) (see Cunningham-Rundler, C.
• hepatitis virus and other virus may be preferentially distributed in some gammaglobulin preparations suitable adjustment of the temperature and time of heating can make any hepatitis virus non-infective and immunogenicand the properly heat-treated lyophilized gamma globulin preparations may function after repeated administration to the recipients at hepatitis or HTLV-III vaccines.
• application of the heatr treatment of lyophilized gammaglobulin preparation may be instituted at any point along the process, selection of an appropriate point along the manufacturing process for applying the heat treatment may be based on pragmatic considerations such as cost or convenience.
• the present invention is thus a cost effective and pragmatic method to substantially inactivate any viruses which may be in the gammaglobulin (immunoglobulin) preparation.
• AIDS-associated retro-virus is sensitive and can inactivate infectious ARV (see Levy, J.R. et al, Lancet 1985 pp. 456-457) when heated in the dry state that is heating by a lyophilized plasma fraction (Factor VIII concentrate) in the dry state at elevated temperatures significantly inactivated infectious ARV.
• a lyophilized plasma fraction Fractor VIII concentrate
• heating gammaglobulin preparations in the lyophilized state at sufficient temperature will significantly inactivate AIDS-associated retrovirus (ARV) .
• hepatitis delta virus may also be transmitted.
• Rosina et al reported the risk of transmitting the hepatitis delta virus by transfusions of blood and blood derivatives that had been screened for HBsAg by third generation methods. The authors estimated the risk of hepatitis delta virus infection as 1 in 3000 transfusions. Since commercial immunoglobuolins are usually obtained from large pools of donors (2,000 to 5,000), transmission of hepatitis delta virus may also originate from this source.”
• the article further states: "In view of the high infectivity of hepatitis delta virus for carriers of HBsAg, the potential risk of transmission of hepatitis delta virus should be considered in treating such carriers with commercial preparations of immunoglobulins.”
• heat treatment according to my invention will also decrease the likelihood of transmission of hepatitis delta virus and the agent (s) causing AIDS.

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• 1987
  • 1987-02-06 WO PCT/US1987/000289 patent/WO1987005220A1/en not_active Application Discontinuation
  • 1987-02-06 AU AU69487/87A patent/AU6948787A/en not_active Abandoned
  • 1987-02-06 EP EP87901863A patent/EP0445108A1/de not_active Withdrawn

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