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 ensures that antibody-based drugs maintain their safety, efficacy, and quality under various storage conditions throughout their shelf life.
2) Scope
This SOP applies to all antibody-based drugs, including monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies, 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
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, aggregation, degradation, sterility) relevant to the antibody-based drug.
- Select appropriate analytical methods (e.g., HPLC, ELISA, Capillary Electrophoresis) to evaluate these parameters.
- Define storage conditions (e.g., refrigerated, frozen) 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 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
Antibody-Based Drug 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