# 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

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_Source: PatentBrief — https://patentbrief.org. Patent facts are from public records; the plain-English explanation is PatentBrief's._