StabilityStudies.in
Comprehensive Stability Study Protocol for Recombinant Proteins
This protocol outlines the procedures for conducting stability studies on recombinant proteins. The study evaluates protein stability, biological activity retention, and degradation under specified environmental conditions.
| Parameter | Details |
|---|---|
| Product Name | [Recombinant Protein Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of recombinant proteins under specified environmental conditions. |
| Test Parameters |
– Protein Stability – Biological Activity  – Physical Integrity |
| Storage Conditions | [e.g., 2-8°C, -20°C] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in protein stability, activity retention, or physical integrity. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |
StabilityStudies.in