{
  "patent_number": "US 20230364252",
  "country": "US",
  "title": "Making Antibody Drug Conjugate Medicines Consistent Across Batches",
  "original_title": "Methods for formulating antibody drug conjugate compositions",
  "summary": "This patent describes methods for precisely controlling the drug amount in antibody drug conjugate (ADC) medicines, ensuring each batch has a consistent strength and effect.",
  "what_it_does": "The patent provides ways to make sure different batches of antibody drug conjugate (ADC) medicines have the same strength. It focuses on reducing \"potency variability,\" meaning how much the drug's effect changes from one batch to another. One method (Claim 1) involves deciding on a specific amount of drug to aim for, based on a set amount of antibody and a fixed \"drug antibody ratio\" (DAR), then mixing the medicine to hit that target. Another detailed method (Claim 6) involves measuring the DAR, defining acceptable ranges for both antibody and drug concentrations, then calculating precise upper and lower limits for the drug concentration using a specific formula. Finally, the medicine is formulated to a drug concentration that is exactly in the middle of these calculated limits, ensuring consistency. For example, if a batch of ADC medicine needs to have a drug concentration within a tight range of 95-105 µg/mL, this method helps achieve that precise target.",
  "what_it_does_not_cover": [
    "Does not cover methods that *only* target a specific antibody concentration without also considering drug concentration (Claim 16).",
    "Does not cover methods that do not involve determining a target drug concentration (Claim 1).",
    "Does not cover methods that do not use a fixed or variable drug antibody ratio (DAR) in their calculations (Claim 1, 2, 6).",
    "Does not cover methods that formulate outside the specified concentration ranges, such as ±5% or ±10% of the targeted drug concentration (Claim 3, 16).",
    "Does not cover methods that do not involve comparing calculated and defined drug specification limits to find effective limits (Claim 6)."
  ],
  "filed": "2022-12-23",
  "granted": null,
  "expires": "2042-12-23",
  "status": "active",
  "holder": "Immunogen",
  "holder_url": "https://patentbrief.org/company/immunogen",
  "inventors": [
    {
      "name": "Juma Bridgewater",
      "url": "https://patentbrief.org/inventor/juma-bridgewater"
    },
    {
      "name": "Gillian Payne",
      "url": "https://patentbrief.org/inventor/gillian-payne"
    },
    {
      "name": "Robert W. Herbst",
      "url": "https://patentbrief.org/inventor/robert-w-herbst"
    }
  ],
  "times_cited": 0,
  "tags": [
    "pharmaceutical",
    "biotech",
    "manufacturing",
    "quality_control",
    "oncology"
  ],
  "abstract": "The present invention provides improved methods for formulating therapeutic compositions comprising an antibody drug conjugate (“ADC”) that reduce potency variability between batches of ADC and provide for administration of such therapeutic compositions within a narrow intended range.",
  "url": "https://patentbrief.org/patent/us/20230364252/methods-for-formulating-antibody-drug-conjugate-compositions",
  "markdown_url": "https://patentbrief.org/patent/us/20230364252/methods-for-formulating-antibody-drug-conjugate-compositions/md",
  "google_patents_url": "https://patents.google.com/patent/US20230364252",
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}