Comprehensive Analytical Data Record for Stability Studies of Recombinant Proteins
This template captures stability data for recombinant proteins, focusing on protein stability, activity retention, degradation products, and sterility over time under various conditions.
| Parameter | Details |
|---|---|
| Product Name | [Recombinant Protein Name] |
| Batch Number | [Batch Number] |
| Test Parameters |
– Protein Stability – Activity Retention  – Sterility |
| Storage Conditions | [e.g., 2-8°C, 25°C/60% RH] |
| Test Intervals | [Specify intervals for testing] |
| Results Summary | [Summarize findings at each interval] |
| Signatories | QA, QC, Regulatory Affairs |