{
  "patent_number": "US 8372396",
  "country": "US",
  "title": "How Specific Antibody Drugs Are Stabilized for Storage and Use",
  "original_title": "Antibody formulations",
  "summary": "Genentech's 2013 patent details a precise recipe for an antibody drug, like Pertuzumab, using a special buffer, sugar, and cleaning agent to keep it stable for patients.",
  "what_it_does": "This patent describes a very specific liquid recipe, or formulation, for antibody medicines, particularly those targeting a protein called HER2. It claims a combination of an antibody (like Pertuzumab, which targets HER2's domain II), a histidine-acetate buffer to control the acidity (pH between 5.5 and 6.5), a sugar like sucrose to help stabilize it, and a cleaning agent called polysorbate 20. The patent specifies exact amounts, such as antibody concentration between 20-40 mg/mL, sucrose from 60-250 mM, and polysorbate 20 from 0.01-0.1%. This precise mix is designed to keep the antibody drug stable and effective, especially in its liquid form, ready for injection into patients. For example, claim 8 specifies a formulation with about 30 mg/mL Pertuzumab, about 20 mM histidine-acetate, about 120 mM sucrose, and about 0.02% polysorbate 20 at pH 6.0.",
  "what_it_does_not_cover": [
    "Antibody formulations not using a histidine-acetate buffer.",
    "Formulations with antibodies that do not bind to domain II of HER2.",
    "Antibody concentrations outside the 20 mg/mL to 40 mg/mL range.",
    "Formulations that have been freeze-dried (lyophilized) before use.",
    "Formulations using different sugars or surfactants than specified.",
    "Antibody formulations with a pH outside the 5.5 to 6.5 range."
  ],
  "filed": "2009-09-04",
  "granted": "2013-02-12",
  "expires": null,
  "status": "active",
  "holder": "Genetech Inc",
  "holder_url": "https://patentbrief.org/company/genetech-inc",
  "inventors": [
    {
      "name": "Shiang C. Gwee",
      "url": "https://patentbrief.org/inventor/shiang-c-gwee"
    },
    {
      "name": "James Andya",
      "url": "https://patentbrief.org/inventor/james-andya"
    },
    {
      "name": "Jun Liu",
      "url": "https://patentbrief.org/inventor/jun-liu"
    },
    {
      "name": "Ye Shen",
      "url": "https://patentbrief.org/inventor/ye-shen"
    }
  ],
  "times_cited": 35,
  "tags": [
    "pharmaceutical",
    "biotech",
    "biotech"
  ],
  "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).",
  "url": "https://patentbrief.org/patent/us/8372396/tysabri-natalizumab",
  "markdown_url": "https://patentbrief.org/patent/us/8372396/tysabri-natalizumab/md",
  "google_patents_url": "https://patents.google.com/patent/US8372396",
  "relatedPatents": []
}