Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Free from infectious agents
Reexamination Certificate
2006-11-21
2006-11-21
Saunders, David (Department: 1644)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Free from infectious agents
C424S177100, C530S390100, C530S390500, C530S416000
Reexamination Certificate
active
07138120
ABSTRACT:
The present invention relates to a process for purifying immunoglobulin G from a crude immunoglobulin-containing plasma protein fraction. Said process includes a number of steps of which the anion exchange chromatography and the cation exchange chromatography are preferably connected in series. An acetate buffer having a pH of about 5.0-6.0 and having a molarity of about 5-25 mM is preferably used throughout the purification process. The invention further comprises an immunoglobulin product which is obtainable by this process. The invention also relates to an immunoglobulin product which has a purity of more than 98%, has a content of IgG monomers and dimers of more than 98.5%, has a content of IgA less than 4 mg of IgA/l, and contains less than 0.5% polymers and aggregates. Said product does not comprise detergent, PEG or albumin as a stabilizer. The product is stable, virus-safe, liquid and ready for instant intravenous administration.
REFERENCES:
patent: 3869436 (1975-03-01), Falksveden
patent: 4272521 (1981-06-01), Zuffi
patent: 4314997 (1982-02-01), Shanbrom
patent: 4315919 (1982-02-01), Shanbrom
patent: 4764369 (1988-08-01), Neurath et al.
patent: 4876088 (1989-10-01), Hirao et al.
patent: 4880913 (1989-11-01), Doleschel et al.
patent: 5164487 (1992-11-01), Kothe et al.
patent: 5177194 (1993-01-01), Sarno et al.
patent: 5593675 (1997-01-01), Hodler et al.
patent: 5886154 (1999-03-01), Lebing et al.
patent: 6069236 (2000-05-01), Burnouf-Radosevich et al.
patent: 6162904 (2000-12-01), Mamidi et al.
patent: 199870099 (1998-12-01), None
patent: 747893 (1999-07-01), None
patent: 2364792 (1974-07-01), None
patent: 3430320 (1998-03-01), None
patent: 0530447 (1997-10-01), None
patent: 0911037 (1999-04-01), None
patent: WO8606727 (1986-11-01), None
patent: 94/29334 (1994-12-01), None
patent: WO9805686 (1998-02-01), None
patent: 9933484 (1999-07-01), None
Biebert, Clinical and Experimental Rheumatology, 14 Suppl 15, S47-S52, 1996.
Brenner, Clinical and Experimental Rheumatology, 14 Suppl 15, S115-S119, 1996.
Mollnes et al, Molecular Immunology, 34, 719-729, 1997.
J Food Sci 58(6) 1993, 1282-90, Fichtali, et al. “Purification of antibodies . . . ”.
J Am Chem Soc 68, 1946, 459-75, Cohn, et al. “Preparation and properties . . . ”.
J Am Chem Soc 71, 1949, 541-50, Oncley, et al “Separation of antibodies . . . ”.
Vox Sang 7, 1962, 414-24, Kistler et al, “Large scale production . . . ”.
Biochem Biophys Acta 82, 1964, 463-75 Polson et al, “Fractionation of protein.”.
Vox Sang 23, 1972, 107-18, Polson et al., “Fractionation of plasma . . . ”.
Blood Separation and Plasma Fractionation, 1991, Wiley-Liss, New York, p 266, Harns, J. (Ed.), FIG. 3.
Anal Biochem 10, 1965, 358-61, Laurell, “Antigen-antibody crossed . . . ”.
Translation of Gammagard. pp. 1-61.
Cohn, E.J. et al., “Preparation and Properties of Serum and Plasma Proteins . . . ,” Separation into Fractions of Protein and Lipoprotein Components, Mar. 1946, vol. 68, pp. 459-475.
Curling, J.M. et al., “Chromatographic Processing of Human . . . ,” Process Biochemistry, Apr. 1997, pp. 22-28.
MIMS Annual 1998.
Translation for German Patent No. DE 34 30 320.
Translation for International Patent No. 94/23334.
Vandersands, J. “Current Approaches to the Preparation fo Plasma Fractions,” Biotechn., 1991, vol. 19: 165-176.
Page, M. et al., “IgG Purification,” Methods in Mol. Biol, 1998, vol. 80: 95-111.
Doonan, S. “Protein Purification Protocols,” Methods in Molecular Biology, vol. 59: 164-165,179,401.
Harlow et al., “Storing and Purifying antibodies,” Antibodies—A Laboratory Manual, 1998, 283-318.
Stevens, L., “Buffers,” Labfax, Bios Scientific Publ. Ltd., Oxford, UK, 1996: 21-26.
Price, N.C., “The Determination of Protein Concentration,” Labfax, Bio Scientific Publ. Ltd., Oxford, UK, 1996: p. 29.
Gammagard® S/D, Product Information from Feb. 1994, Baxter Deutschland GmbH, Edisonstr. 3-4, D-85716 Unterschleissheim. Translation pages.
Nourichafi, N. et al., “Comparison of various chromatographic . . . ,” Biotechnology of Blood Proteins, 1993, vol. 227: 207-212.
Andersson et al., “An improved chromatography method . . . ,” XXII Congress of the International Society of Blood Transfusion, Amsterdam, the Netherlands, 1994, Jul. 2-8. Published by Pharmacia Biotech AB, S-75182 Uppsala SWEDEN.
Page et al., “Preparation of Purified Immunoglobulin G (IgG),” Methods in Molecular Biology, vol. 32, 1994: 407-431.
Pasano, Mary Beth, “Risks and benefits of intravenous immunoglobulin treatment in children,” Current Opinion in Pediatrics 1995,7:688-694.
Josic, et al., “Factor VIII”, Vox Sanguinis, International Journal of Transfusion Medicine, Jul. 1994, vol. 67, S2-94, pp. 112 [0517].
Josic, et al., “Purification of Alpha . . . ”, International Journal of Transfusion Medicine, Jul. 1994, vol. 67, S2-94, pp. 112 [0518].
Lew, et al., “Sterilizing 100° C. (Boiling) Terminal Dry Heat Treatment of Factor VIII . . . ”, International Journal of Transfusion Medicine, Jul. 1994, vol. 67, S2-94, pp. 112 [0519].
Anderson, et al. “An Improved Chromatography Method for Production of IgG from Human Plasma.”, International Journal of Transfusion Medicine, Jul. 1994, vol. 67, S2-94, pp. 112 [0520].
Laursen Inga
Teisner Børge
Saunders David
Statens Serum Institut
Svensson Leonard R.
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