# A Stable Recipe for a Cancer-Fighting Antibody Drug > 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. - **Patent:** US 10391181 - **Original title:** Cyclodextrin and antibody-drug conjugate formulations - **Owner:** Seattle Genetics - **Granted:** 2019 - **Status:** Active - **Times cited:** 1 - **Field:** pharmaceutical, biotech, oncology, drug_delivery ## 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. ## The clever bit The novelty lies in identifying a very specific combination of excipients—hydroxypropyl-β-cyclodextrin, sucrose, and KPhos buffer—that together stabilize a particular benzodiazepine ADC and keep a specific impurity below a critical threshold. This precise "recipe" solves the challenge of maintaining the drug's integrity and potency. ## Real-world examples 1. ADC therapies for cancer treatment 2. Lyophilized (freeze-dried) pharmaceutical products 3. Formulations for biologics 4. Seattle Genetics (Seagen) ADC pipeline ## Why it matters Antibody-drug conjugates are powerful cancer treatments, but they are complex molecules that can be unstable or degrade over time. This patent addresses a critical challenge in drug development: creating a stable, pharmaceutically acceptable formulation for a specific ADC. Ensuring stability and purity is essential for drug safety, efficacy, and shelf-life, which directly impacts patient access and treatment reliability. Seattle Genetics (now Seagen) is a leader in ADC technology, and this patent contributes to the practical application and commercial viability of such therapies. ## Frequently asked questions ### What does A Stable Recipe for a Cancer-Fighting Antibody Drug cover? 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. ### Who owns patent US 10391181? Seattle Genetics owns this patent, granted in 2019. ### When does this patent expire? This patent is expected to expire on April 30, 2038, when the invention enters the public domain. ### What is patent US 10391181 cited by? This patent has been cited by 1 later patents that build on its ideas. ### What problem does this patent solve? Antibody-drug conjugates are powerful cancer treatments, but they are complex molecules that can be unstable or degrade over time. This patent addresses a critical challenge in drug development: creating a stable, pharmaceutically acceptable formulation for a specific ADC. Ensuring stability and purity is essential for drug safety, efficacy, and shelf-life, which directly impacts patient access and treatment reliability. Seattle Genetics (now Seagen) is a leader in ADC technology, and this patent contributes to the practical application and commercial viability of such therapies. ### What does this patent NOT cover? Does not cover ADC formulations that do not include a cyclodextrin, such as hydroxypropyl-β-cyclodextrin. **Full plain-English explainer:** https://patentbrief.org/patent/us/10391181/cyclodextrin-and-antibody-drug-conjugate-formulations **Original patent:** https://patents.google.com/patent/US10391181 --- _Source: PatentBrief — https://patentbrief.org. Patent facts are from public records; the plain-English explanation is PatentBrief's._ ## Related patents Semantically similar inventions in the PatentBrief corpus: - [Making Antibody Drug Conjugate Medicines Consistent Across Batches](https://patentbrief.org/patent/us/20230364252/methods-for-formulating-antibody-drug-conjugate-compositions) — 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. - [How Specific Antibody Drugs Are Stabilized for Storage and Use](https://patentbrief.org/patent/us/8372396/tysabri-natalizumab) — 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. - [Making Cancer-Fighting Antibody Drugs Safer with Precise Attachment](https://patentbrief.org/patent/us/12121527/anthracycline-based-antibody-drug-conjugates-having-high-in-vivo-tolerability) — This patent describes a specific way to build antibody-drug conjugates (ADCs) for cancer treatment by precisely attaching chemotherapy drugs to antibodies to make them safer inside the body. - [Making High-Concentration Antibody Medicines Stable for Injection](https://patentbrief.org/patent/us/6267958/rituxan-chop) — 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. - [Targeted Cancer Drugs Using Antibodies and Polymer Scaffolds](https://patentbrief.org/patent/us/20210301031/napi2b-targeted-antibody-drug-conjugates-and-methods-of-use-thereof) — This patent describes a new way to deliver powerful cancer drugs directly to tumor cells using a specific antibody attached to a special polymer, aiming to reduce side effects.