- Biologicals and relevant Guidelines
- Specific differences between chemical entities and biologicals
- Stability-indicating profile of Monoclonal Antibodies and Immunoglobulins
- Storage conditions
- Impact of changes on stability
- Submitting stability data within the CTD-structure
Stability Studies and shelf-life Determination, starting Activities and Study Report
- Prerequisites for performing a stab study
- Concepts for study design and reporting
- Start, study performance and study closing
- Regulatory aspects during product development
- Objectives for a final stab study report
Stability Studies beyond Lot Stability
- Selection of appropriate, sensitive methods
- Analysis of stressed samples
- Statistical interpretation of shifts and drifts
- Acceptance limits
Study Design, Impurities and Stability Specifications
Degradation of Polysorbate
- Mechanisms of Polysorbate Degradation
- Consequences of Polysorbate degradation
- Analytical tool box for degradation assessment
Stability Requirements of the new Guideline on Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
- Control of excipients
- Specifications, batch analysis
- Stability data
- Shelf-life Determination
- Post approval Extension
- Substantial amendments