Guidelines for Stability Testing of Biological Drug Products
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biological drug products. Stability testing is necessary to ensure that biological products retain their potency, safety, and quality throughout their shelf life under various storage conditions.
2) Scope
This SOP applies to all biological drug products, including monoclonal antibodies, recombinant proteins, and vaccines, 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
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 
- Identify stability-indicating parameters (e.g., potency, purity, sterility, and aggregation) relevant to the biological drug product.
- Select appropriate analytical methods (e.g., HPLC, ELISA, Mass Spectrometry) to evaluate these parameters.
- Define storage conditions (e.g., refrigerated, frozen) based on the product’s characteristics and regulatory guidelines.
- Develop a detailed study protocol outlining the objectives, sampling schedule, and analytical methods.
4.2 Sample Preparation:
- Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under specified conditions.
4.3 Testing Schedule:
- Conduct initial testing to establish baseline data for all selected parameters.
- Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes over time.
- Document all test results and analyze data for trends or deviations from acceptance criteria.
4.4 Data Analysis and Reporting:
- Analyze data using appropriate statistical methods to determine trends and compliance with acceptance criteria.
- Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling conditions.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
ELISA: Enzyme-Linked Immunosorbent Assay
6) Documents, if any
Biological Product Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
8) SOP Version
Version 1.0