Guidelines for Stability Testing of Antibody-Based Drugs

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on antibody-based drugs. Stability testing is essential to ensure that these drugs maintain their potency, safety, and quality throughout their shelf life under various storage conditions.

2) Scope

This SOP applies to all antibody-based drugs, including monoclonal antibodies, polyclonal antibodies, and antibody fragments, produced or handled by the organization. It is intended for personnel involved in formulation development, quality control, and regulatory compliance.

3) Responsibilities

Formulation Scientist: Responsible for designing the stability study protocol and selecting appropriate stability-indicating parameters.

Quality Control (QC) Team: Responsible for conducting stability tests according to the approved protocol and documenting results.

QA Team: Responsible for reviewing data, ensuring regulatory compliance, and approving the final stability report.

4) Procedure

4.1 Study Design:

1. Identify stability-indicating parameters (e.g., potency, purity, sterility, aggregation) relevant to the antibody-based drug.
2. Select
   

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   appropriate analytical methods (e.g., HPLC, ELISA, SDS-PAGE) to evaluate these parameters.
3. Define storage conditions (e.g., refrigerated, frozen) based on the product’s characteristics and regulatory guidelines.
4. Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used.

4.2 Sample Preparation:

1. Prepare samples from representative production batches and label them with batch numbers, storage