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Standard Operating Procedure for Stability Testing of Antibody-Based Therapeutics

1) Purpose

The purpose of this SOP is to provide a standardized approach for assessing the stability of antibody-based drugs. The aim is to ensure that these biologics maintain their quality, safety, and efficacy throughout their shelf life under varying environmental conditions.

2) Scope

This SOP is applicable to all antibody-based drugs, including monoclonal and polyclonal antibodies, manufactured and stored within the facility. It covers all relevant departments such as production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing using methods such as ELISA, HPLC, and mass spectrometry.
• Quality Assurance (QA) Team: Reviews protocols, test results, and ensures compliance with regulatory requirements.
• Production Team: Provides necessary samples and ensures proper documentation of batch records.

4) Procedure

1. Sample Preparation
   1. Collect samples from antibody production batches, ensuring that they are representative of the final
      

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      product.
   2. Store the samples at recommended conditions until they are placed into stability chambers.
2. Stability Study Design
   1. Draft a stability study protocol detailing the storage conditions, testing intervals, and analytical methods.
   2. Obtain approval from the QA and Regulatory Affairs teams.
3. Execution of the Stability Study
   1. Store samples in stability chambers under defined conditions (e.g., 5°C, 25°C/60% RH).
   2. Conduct tests at each interval, including binding affinity, aggregation, and degradation profile.
   3. Record and document all observations, test results, and any deviations.
4. Data Analysis
   1. Analyze the stability data to detect any changes in potency, purity, or efficacy over time.
   2. Prepare and submit a detailed report to the QA team for review and approval.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ELISA: Enzyme-Linked Immunosorbent Assay

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 1.0

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