# How Specific Antibody Drugs Are Stabilized for Storage and Use > 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. - **Patent:** US 8372396 - **Original title:** Antibody formulations - **Owner:** Genetech Inc - **Granted:** 2013 - **Status:** Active - **Times cited:** 35 - **Field:** pharmaceutical, biotech, biotech ## 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. ## The clever bit The innovation lies in identifying a precise combination of buffer, sugar, and surfactant at specific concentrations and pH that prevents the antibody from degrading or clumping in a liquid state, making it ready for use without requiring freezing or lyophilization. ## Real-world examples 1. Pertuzumab (Perjeta) formulations 2. Liquid antibody drug formulations 3. Pharmaceuticals requiring high stability ## Why it matters This patent is significant because it addresses the critical challenge of keeping complex biological drugs, like monoclonal antibodies, stable and effective outside of a frozen state. Stable liquid formulations are crucial for easier storage, handling, and administration to patients, especially for targeted cancer therapies like Pertuzumab (marketed as Perjeta). ## Frequently asked questions ### What does How Specific Antibody Drugs Are Stabilized for Storage and Use cover? 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. ### Who owns patent US 8372396? Genetech Inc owns this patent, granted in 2013. ### When does this patent expire? This patent is expected to expire on February 12, 2033, when the invention enters the public domain. ### What is patent US 8372396 cited by? This patent has been cited by 35 later patents that build on its ideas. ### What problem does this patent solve? This patent is significant because it addresses the critical challenge of keeping complex biological drugs, like monoclonal antibodies, stable and effective outside of a frozen state. Stable liquid formulations are crucial for easier storage, handling, and administration to patients, especially for targeted cancer therapies like Pertuzumab (marketed as Perjeta). ### What does this patent NOT cover? Antibody formulations not using a histidine-acetate buffer. **Full plain-English explainer:** https://patentbrief.org/patent/us/8372396/tysabri-natalizumab **Original patent:** https://patents.google.com/patent/US8372396 --- _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 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. - [How to Keep High-Concentration Antibody Medicines Stable in Liquid Form](https://patentbrief.org/patent/us/7740842/herceptin-adjuvant-therapy) — Novartis's patent describes a specific liquid recipe for keeping high concentrations of E25 anti-IgE antibodies stable and usable for medical injections. - [How to Keep Humira Stable in a Liquid Medicine Bottle](https://patentbrief.org/patent/us/8216583/humira-dosing-regimen) — A recipe for a stable, liquid version of the drug Humira that stays effective at high concentrations without spoiling or clumping. - [How Genentech Purifies Therapeutic Antibodies for Cancer Treatment](https://patentbrief.org/patent/us/6339142/rituxan-rituximab) — A method for refining mixtures of anti-HER2 antibodies to ensure that harmful acidic variants remain below 25 percent of the total composition. - [How Genentech Created Antibodies to Target Prostate Cancer Cells](https://patentbrief.org/patent/us/6824780/avastin-dosing) — A patent describing specific antibodies that latch onto and kill cancer cells expressing the PSCA protein, effectively turning the body's immune-targeting tools into cancer-fighting weapons.