Guidelines for Stability Testing of Temperature-Sensitive Biologics
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on temperature-sensitive biologics. Stability testing is necessary to ensure that these biologics maintain their safety, efficacy, and quality under various storage conditions throughout their shelf life.
2) Scope
This SOP applies to all temperature-sensitive biologic products, including vaccines, monoclonal antibodies, and other biologic formulations, 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
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:
- Identify stability-indicating parameters (e.g., potency, purity, sterility, aggregation) relevant to the temperature-sensitive biologic product.
- Select appropriate analytical methods (e.g., HPLC, ELISA, SDS-PAGE) to evaluate these parameters.
- Define storage conditions (e.g., refrigerated, frozen, controlled room temperature) based on the product’s characteristics and regulatory guidelines.
- Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used.
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 on all samples to establish baseline data for the selected parameters.
- Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes in stability 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
SDS-PAGE: Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis
6) Documents, if any
Temperature-Sensitive Biologic Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q5C: Stability Testing of Biotechnological/Biological Products
8) SOP Version
Version 1.0