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  Antibody formulationsUSPTO Application #: 20060088523Title: Antibody formulations Abstract: The present application describes antibody formulations, including monoclonal antibodies formulated in histidine-acetate buffer, as well as a formulation comprising an antibody that binds to domain II of HER2 (for example, Pertuzumab), and a formulation comprising an antibody that binds to DR5 (for example, Apomab). (end of abstract)
Agent: Genentech, Inc. - South San Francisco, CA, US Inventors: James Andya, Shiang C. Gwee, Jun Liu, Ye Shen USPTO Applicaton #: 20060088523 - Class: 424133100 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Immunoglobulin, Antiserum, Antibody, Or Antibody Fragment, Except Conjugate Or Complex Of The Same With Nonimmunoglobulin Material, Structurally-modified Antibody, Immunoglobulin, Or Fragment Thereof (e.g., Chimeric, Humanized, Cdr-grafted, Mutated, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20060088523. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This is a non-provisional application filed under 37 CFR 1.53(b) claiming priority to provisional application 60/620,413 filed Oct. 20, 2004, the contents of which are incorporated herein by reference FIELD OF THE INVENTION [0002] The present invention concerns antibody formulations, including monoclonal antibodies formulated in histidine-acetate buffer, as well as a formulation comprising an antibody that binds to domain II of HER2 (for example, Pertuzumab), and a formulation comprising an antibody that binds to DR5 (for example, Apomab). BACKGROUND OF THE INVENTION [0003] In the past ten years, advances in biotechnology have made it possible to produce a variety of proteins for pharmaceutical applications using recombinant DNA techniques. Because proteins are larger and more complex than traditional organic and inorganic drugs (i.e. possessing multiple functional groups in addition to complex three-dimensional structures), the formulation of such proteins poses special problems. For a protein to remain biologically active, a formulation must preserve intact the conformational integrity of at least a core sequence of the protein's amino acids while at the same time protecting the protein's multiple functional groups from degradation. Degradation pathways for proteins can involve chemical instability (i.e. any process which involves modification of the protein by bond formation or cleavage resulting in a new chemical entity) or physical instability (i.e. changes in the higher order structure of the protein). Chemical instability can result from deamidation, racemization, hydrolysis, oxidation, beta elimination or disulfide exchange. Physical instability can result from denaturation, aggregation, precipitation or adsorption, for example. The three most common protein degradation pathways are protein aggregation, deamidation and oxidation. Cleland et al. Critical Reviews in Therapeutic Drug Carrier Systems 10(4): 307-377 (1993). ANTIBODY FORMULATIONS [0004] Included in the proteins used for pharmaceutical applications are antibodies. An example of an antibody useful for therapy is an antibody which binds to the HER2 antigen, such as Pertuzumab. [0005] U.S. Pat. No. 6,339,142 describes a HER2 antibody composition comprising a mixture of anti-HER2 antibody and one or more acidic variants thereof, wherein the amount of the acidic variant(s) is less than about 25%. Trastuzumab is an exemplified HER2 antibody. [0006] U.S. Pat. Nos. 6,267,958 and 6,685,940 (Andya et al.) describe lyophilized antibody formulations, including HER2 and IgE antibody formulations. WO97/04807 and US 2004/0197326A1 (Fick et al.) describe methods for treating allergic asthma with an IgE antibody. WO99/01556 (Lowman et al.) relates to IgE antibody with aspartyl residues prone to isomerization, and improved variants thereof. US 2002/0045571 (Liu et al.) provides reduced viscosity concentrated protein formulations, exemplified by humanized IgE antibody formulations, rhuMAb E25 and E26. WO 02/096457 and US 2004/0170623 (Arvinte et al.) describes stable liquid formulations comprising anti-IgE antibody E25. See, also, US 2004/0197324 A1 (Liu and Shire) concerning high concentration anti-IgE formulation. [0007] U.S. Pat. No. 6,171,586 (Lam et al.) describes stable aqueous antibody formulations. A F(ab')2 rhuMAb CD18 antibody was formulated in sodium acetate and histidine-HCl buffers. The preferred formulation for rhuMAb CD18 was 10 mM sodium acetate, 8% trehalose, 0.01% TWEEN 20.TM., pH 5.0. Acetate (pH 5.0) formulations of rhuMAb CD20 stored at 40.degree. for one month demonstrated greater stability than those samples formulated in histidine (pH 5.0 or 6.0). [0008] US 2003/0190316 (Kakuta et al.) concerns formulated antibody hPM-1, a humanized IL-6 receptor antibody. Monomer loss was the greatest in sodium citrate (pH 6.7), followed by sodium phosphate (pH 6.8), Tris-HCl (pH 7.2), histidine-HCI (pH 7.2) and glycine (pH 7.6) in descending order. The effect of phosphate-Na (pH 6.5), phosphate-His (pH 6.0 or 6.5), His-HCl (pH 6.5), and phosphate-Na (pH 6.0) on the stability of hPM-1 was assessed. [0009] WO2004/071439 (Burke et al.) state that impurities arose in a natalizumab (anti-alpha4 integrin humanized monoclonal antibody) formulation from the degradation of polysorbate 80, apparently through an oxidation reaction involving metal ions and hisitidine. Thus, a phosphate buffer was selected. [0010] WO 2000/066160 (English language counterpart EP 1 174 148A1) (Okada et al.) refers to a formulation of a humanized C4G1 antibody which binds to a fibrinogen receptor of a human platelet membrane glycoprotein GPIIb/IIIa, in a sodium phosphate or sodium citrate buffer. [0011] WO2004/019861 (Johnson et al.) concerns CDP870, a pegylated anti-TNF.alpha. Fab fragment, formulated at 200 mg/ml in 50 mM sodium acetate (pH 5.5) and 125 mM sodium chloride. [0012] WO2004/004639 (Nesta, P.) refers to a formulation for huC242-DM1, a tumor-activated immunotoxin, in a 50 mM succinic acid buffer (pH 6.0) and sucrose (5% w/v). [0013] WO03/039485 (Kaisheva et al.) found that Daclizumab (a humanized IL-2 receptor antibody) had the highest stability in sodium succinate buffer at pH 6.0, and rapidly lost potency in histidine as the buffer oxidized. [0014] WO 2004/001007 concerns a CD80 monoclonal antibody in a histidine HCl, sodium acetate or sodium citrate buffer. [0015] U.S. Pat. No. 6,252,055 (Relton, J.) refers to anti-CD4 and anti-CD23 antibodies formulated in maleate, succinate, sodium acetate or phosphate buffers, with phosphate being identified as the preferred buffer. [0016] U.S. Pat. No. 5,608,038 (Eibl et al.) refers to highly concentrated polyclonal immunoglobulin preparations with immunoglobulin, glucose or sucrose, and sodium chloride therein. [0017] WO03/015894 (Oliver et al.) refers to an aqueous formulation of 100 mg/mL SYNAGIS.RTM., 25 mM histidine-HCl, 1.6 mM glycine, pH 6.0, and a lyophilized SYNAGIS.RTM. which when formulated (before lyophilization) contains 25 mM histidine, 1.6 mM glycine and 3% w/v mannitol at pH 6.0. [0018] US 2004/0191243 A1 (Chen et al.) reports formulation of ABX-IL8, a human IgG2 antibody. [0019] US 2003/0113316 A1 (Kaisheva et al.) refers to a lyophilized anti-IL2 receptor antibody formulation. HER2 Antibodies [0020] The HER family of receptor tyrosine kinases are important mediators of cell growth, differentiation and survival. The receptor family includes four distinct members including epidermal growth factor receptor (EGFR, ErbB1, or HER1), HER2 (ErbB2 or p185.sup.neu), HER3 (ErbB3) and HER4 (ErbB4 or tyro2). Continue reading... Full patent description for Antibody formulations Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Antibody formulations patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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