StabilityStudies.in

SOP for Conducting Stability Studies for Recombinant Proteins

Standard Operating Procedure for Stability Testing of Recombinant Proteins

1) Purpose

The purpose of this SOP is to establish a standard method for conducting stability studies on recombinant protein products. These studies aim to ensure that the proteins maintain their biological activity, potency, and safety throughout their shelf life under various environmental conditions.

2) Scope

This SOP applies to all recombinant protein drug products manufactured, tested, or stored in the facility. It covers the departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing and records results.
Quality Assurance (QA)

Team: Reviews and approves the stability study protocol and final reports.

Production Team: Provides samples from the relevant production batches.

4) Procedure

Preparation of Samples
1. Obtain representative samples of the recombinant protein product from recent production batches.
2. Ensure samples are stored under appropriate
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  conditions until the study commences.
Development of Stability Study Protocol
1. Prepare a protocol outlining the study’s objectives, test intervals, storage conditions, and analytical methods to be used (e.g., HPLC, ELISA, SDS-PAGE).
2. Submit the protocol to the QA and Regulatory Affairs teams for approval.
Execution of Stability Study
1. Store samples in designated stability chambers under controlled conditions (e.g., 2-8°C, -20°C).
2. Perform analytical tests at each specified interval to evaluate the physical and chemical stability of the recombinant protein.
3. Document all observations, data, and deviations from the protocol.
Data Analysis and Reporting
1. Analyze the data to assess whether the recombinant protein remains stable under the tested conditions.
2. Prepare a stability study report and submit it to the QA team for review.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
ELISA: Enzyme-Linked Immunosorbent Assay

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q5C: Stability Testing of Biotechnological/Biological Products
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity

8) SOP Version

Version 1.0