Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Separation or purification
Patent
1992-03-12
1994-08-09
Russel, Jeffrey E.
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Separation or purification
209 39, 209214, 2092232, 210222, 210695, 422270, 436526, 530811, B03C 132, C07K 318, C07K 1714, G01N 33553
Patent
active
053367600
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The present invention is related to devices and methods of using the same, to prepare pharmaceutical compositions comprising a complex of an antigen component and the corresponding antibody or inhibitor component in a pharmacologically acceptable carrier. Specifically, the invention concerns a device and method of using the same, of preparing a pharmaceutical composition by selectively isolating an antibody type component from a physiological fluid, such as blood, plasma or other bodily fluid in a pharmacologically acceptable carrier to which the antigen type compound may be added.
Pharmaceutical compositions containing antibody/antigen complexes have been suggested for numerous medical applications. For example, U.S. Pat. No. 4,740,371, issued to St. Remy et al on Apr. 26, 1988, disclosed a complex useful for treating allergies. This complex includes the specific allergen that causes the allergic reaction, and the corresponding antibody for that allergen. While the antibodies may be derived from either the patient's or a donor's physiological fluids, the preferred antibody is usually derived from the patient's own physiological fluids. The injection of this complex reduces, and even eliminates, a patient's allergic reaction to the specific allergen, while not possessing the side effects accompanying conventional allergy treatments.
Another antibody/antigen complex is taught in EP 426913, published May 15, 1991. This application discloses a complex composed of factor VIII and an antibody termed factor VIII inhibitor. This complex is used to treat hemophiliacs who have become refractory to the injection of factor VIII. These individuals produce a factor VIII inhibitor antibody which binds with, and renders factor VIII inactive. Thus factor VIII functions as the antigen, while the anti-factor VIII functions as the antibody. It was demonstrated that the injection of the factor VIII antigen/inhibitor complex reduces some patient's refractortness to factor VIII injections.
The antigen/antibody complexes taught in St. Remy et al and the pending application preferably use the antibody from the patient's own physiological fluids. This is significant not only because it eliminates any potential reaction to an antibody prepared from a non-identical donor, but more importantly, autologous antibodies are most effective for induction of the therapy itself. The presently available methods, as taught by St. Remy et al and the referenced application, of extracting the antibodies requires painstaking chemical isolation of the antibody from the patient's bodily fluid, such as blood. For example, St. Remy et al discloses isolating the desired antibodies IgG, IgM, IgA, IgE, and IgD by a complex series of steps involving precipitation, dialysis, concentration, chromatography and immunoadsorption.
Thus while pharmaceutical compositions containing antigen/antibody complexes may be beneficial in the treatment of certain diseases and conditions, the methods of isolating the desired antibody are complex and time consuming. It is thus desirable to provide a mechanism to readily prepare pharmaceutical antibody/antigen complexes.
Recent advances in separation technology have presented the opportunity of isolating a specific target population, e.g. cells, proteins, or antibodies without the need of tedious and extensive chemical separation techniques. For example, various workers have suggested capturing specific target populations by using filters bearing immunoreactive groups. Immunoreactive groups are those to which the desired antibody will selectively bind, typically the antigen. These techniques include filters prepared from fibers bearing immunoreactive groups, U.S. Pat. No. 3,843,324, issued on Oct. 22, 1974; columns bearing immunoreactive group, U.S. Pat. No. 4,252,653, issued on Feb. 24, 1981; and filter candles bearing immunoreactive groups, U.S. Pat. No. 4,648,974, issued Mar. 10, 1987.
Another recently developed technique for isolating target populations, i.e. antibodies, selected proteins and
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"Removal of Neuroblastoma Cells from Bone Marrow with Monoclonal Antibodies Conjugated to Magnetic Microspheres" by J. G. Treleaven, J. Ugelstadt, T. Philips, F. M. Gibson, A. Rembaum, G. D. Caine, and J. T. Kemshead, The Lancet, (Jan. 14, 1984), pp. 70-73.
Chenoweth Dennis E.
Hardwick R. Alan
Lake William C.
Smith Alan K.
Baxter International Inc.
Guthrie Janice
Russel Jeffrey E.
Schiffer Michael
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