StabilityStudies.in

SOP for Assessing Stability for Antibody-Based Drugs

Standard Operating Procedure for Conducting Stability Studies on Antibody Drugs

1) Purpose

This SOP outlines the procedure for assessing the stability of antibody-based drugs, such as monoclonal and polyclonal antibodies, to ensure that they retain their quality, potency, and safety during their shelf life. Stability studies help in determining the storage conditions and shelf life of antibody-based drugs.

2) Scope

This SOP applies to all antibody-based drug products, including monoclonal and polyclonal antibodies, manufactured, stored, or tested in the facility. It is relevant to the departments of production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

Quality Control (QC)

Team: Responsible for conducting stability tests using appropriate analytical methods, such as ELISA, HPLC, and size-exclusion chromatography.

Quality Assurance (QA) Team: Responsible for reviewing and approving the study protocol and ensuring all processes comply with regulatory requirements.

Production Team: Responsible for providing samples and maintaining proper batch documentation.

4) Procedure

Preparation of Samples
1. Obtain representative samples from each batch of antibody-based drugs produced.
2. Ensure samples are stored under conditions that maintain their stability until the study begins.
Design of Stability Study
1. Develop a stability study protocol that includes details on storage conditions (e.g., 2-8°C, 25°C/60% RH), testing intervals, and analytical methods to be used.
2. Submit the protocol to the QA team for review and approval.
Conducting the Stability Study
1. Store samples in designated stability chambers under defined conditions as per the protocol.
2. Perform stability tests at each specified interval, including assessments of binding affinity, aggregation, purity, and degradation.
3. Record all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to determine any changes in potency, purity, or efficacy of the antibody-based drugs over time.
2. Prepare a detailed stability study report and submit it to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
ELISA: Enzyme-Linked Immunosorbent Assay
HPLC: High-Performance Liquid Chromatography
RH: Relative Humidity

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q5C: Stability Testing of Biotechnological/Biological Products
FDA Guidance for Industry: Monoclonal Antibodies Used as Reagents

8) SOP Version

Version 1.1