{
  "patent_number": "US 6267958",
  "country": "US",
  "title": "Making High-Concentration Antibody Medicines Stable for Injection",
  "original_title": "Protein formulation",
  "summary": "Genentech's 2001 patent on a method to create stable, concentrated antibody medicines that can be easily reconstituted for injection, preventing degradation during freezing and storage.",
  "what_it_does": "This patent describes how to prepare a stable, concentrated liquid medicine from a frozen-dried (lyophilized) powder containing an antibody. The key is using a special ingredient called a 'lyoprotectant' in a specific ratio (about 100 to 510 moles of lyoprotectant for every 1 mole of antibody). This lyoprotectant protects the antibody from breaking down during the freezing and drying process and while it's stored. When you add liquid back to the powder, you get a medicine with a high concentration of antibody, between 50 to 400 mg/mL, which is stable and ready for injection, often for subcutaneous administration. For example, it covers making a stable, concentrated anti-HER2 antibody formulation ready for use.",
  "what_it_does_not_cover": [
    "Formulations where the antibody concentration after reconstitution is less than 50 mg/mL.",
    "Formulations that do not use a lyoprotectant during the lyophilization process.",
    "Formulations where the molar ratio of lyoprotectant to antibody is outside the range of 100-510:1.",
    "Reconstituted formulations that are not isotonic (having the same salt concentration as body fluids).",
    "Medicines that are not antibodies, such as small molecule drugs."
  ],
  "filed": "1996-03-14",
  "granted": "2001-07-31",
  "expires": null,
  "status": "active",
  "holder": "Genentech Inc",
  "holder_url": "https://patentbrief.org/company/genentech-inc",
  "inventors": [
    {
      "name": "James Andya",
      "url": "https://patentbrief.org/inventor/james-andya"
    },
    {
      "name": "Xanthe M. Lam",
      "url": "https://patentbrief.org/inventor/xanthe-m-lam"
    },
    {
      "name": "Janet Yu-Feng Yang",
      "url": "https://patentbrief.org/inventor/janet-yu-feng-yang"
    },
    {
      "name": "Jeffrey L. Cleland",
      "url": "https://patentbrief.org/inventor/jeffrey-l-cleland"
    },
    {
      "name": "David E. Overcashier",
      "url": "https://patentbrief.org/inventor/david-e-overcashier"
    },
    {
      "name": "Chung C. Hsu",
      "url": "https://patentbrief.org/inventor/chung-c-hsu"
    },
    {
      "name": "Steven J. Shire",
      "url": "https://patentbrief.org/inventor/steven-j-shire"
    },
    {
      "name": "Sylvia Sau-Yan Wu",
      "url": "https://patentbrief.org/inventor/sylvia-sau-yan-wu"
    }
  ],
  "times_cited": 878,
  "tags": [
    "pharmaceutical",
    "biotech",
    "materials"
  ],
  "abstract": "A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.",
  "url": "https://patentbrief.org/patent/us/6267958/rituxan-chop",
  "markdown_url": "https://patentbrief.org/patent/us/6267958/rituxan-chop/md",
  "google_patents_url": "https://patents.google.com/patent/US6267958",
  "relatedPatents": []
}