{
  "patent_number": "US 10391181",
  "country": "US",
  "title": "A Stable Recipe for a Cancer-Fighting Antibody Drug",
  "original_title": "Cyclodextrin and antibody-drug conjugate formulations",
  "summary": "This patent describes a specific, stable recipe for a cancer-fighting antibody-drug conjugate (ADC) that targets CD33, using cyclodextrin and a lyoprotectant to keep it effective and reduce impurities.",
  "what_it_does": "The patent describes a specific pharmaceutical mixture, or \"formulation,\" for a type of cancer drug called a benzodiazepine antibody-drug conjugate (ADC). This formulation aims to keep the ADC stable and minimize unwanted byproducts. It includes a specific monoclonal antibody, h2H16ec, designed to target human CD33, with an average of two drug molecules attached to engineered cysteine residues (Claim 1(a)). The formulation strictly limits a benzodiazepine-related impurity to no more than 0.1 μM (Claim 1(b)). To achieve stability, it uses 6% w/v hydroxypropyl-β-cyclodextrin (Claim 1(c)), 6% w/v sucrose as a lyoprotectant (Claim 1(d)), and a 20 mM KPhos buffer at pH 7.3 as a diluent (Claim 1(e)). For example, this precise mixture could be prepared and then freeze-dried for storage, ensuring the drug remains potent until it's ready for patient use.",
  "what_it_does_not_cover": [
    "Does not cover ADC formulations that do not include a cyclodextrin, such as hydroxypropyl-β-cyclodextrin.",
    "Does not cover formulations where the specific benzodiazepine-related impurity exceeds 0.1 μM.",
    "Does not cover ADCs where the antibody does not specifically target human CD33, or is not h2H16ec with engineered cysteine residues.",
    "Does not cover formulations using different lyoprotectants or diluents outside of 6% w/v sucrose and 20 mM KPhos buffer at pH 7.3.",
    "Does not cover methods of making the ADC itself, only its final formulation."
  ],
  "filed": "2018-04-30",
  "granted": "2019-08-27",
  "expires": "2038-04-30",
  "status": "active",
  "holder": "Seattle Genetics",
  "holder_url": "https://patentbrief.org/company/seattle-genetics",
  "inventors": [
    {
      "name": "Shan Jiang",
      "url": "https://patentbrief.org/inventor/shan-jiang"
    },
    {
      "name": "Damon Meyer",
      "url": "https://patentbrief.org/inventor/damon-meyer"
    },
    {
      "name": "Mary Wallace",
      "url": "https://patentbrief.org/inventor/mary-wallace"
    },
    {
      "name": "Hui Li",
      "url": "https://patentbrief.org/inventor/hui-li"
    }
  ],
  "times_cited": 1,
  "tags": [
    "pharmaceutical",
    "biotech",
    "oncology",
    "drug_delivery"
  ],
  "abstract": "Disclosed are formulations, including both liquid and lyophilized formulations, comprising a benzodiazepine antibody-drug conjugate (ADC) and a cyclodextrin. Also disclosed are methods of purifying mixtures comprising benzodiazepine antibody-drug conjugates and process drug-related impurities.",
  "url": "https://patentbrief.org/patent/us/10391181/cyclodextrin-and-antibody-drug-conjugate-formulations",
  "markdown_url": "https://patentbrief.org/patent/us/10391181/cyclodextrin-and-antibody-drug-conjugate-formulations/md",
  "google_patents_url": "https://patents.google.com/patent/US10391181",
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}