Standard Operating Procedure for Preparation of Protein-Based Lyophilized Formulations

1) Purpose

The purpose of this SOP is to provide guidelines for the preparation of protein-based formulations intended for lyophilization. It ensures the stability and activity of proteins throughout the process, maintaining their biological functionality.

2) Scope

This SOP applies to all personnel involved in the preparation of protein-based formulations for lyophilized products, including formulation scientists, production operators, and QA teams.

3) Responsibilities

• Formulation Scientists: Responsible for designing the protein formulation and selecting appropriate stabilizers.
• Operators: Responsible for preparing the protein-based solution following the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the process and ensuring all documentation is accurate.

4) Procedure

4.1 Preparation of Protein Solution

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment used in the preparation is sanitized and calibrated.
• 4.1.1.2 Prepare sterile containers for the solution and maintain a cleanroom environment to prevent contamination.

4.1.2 Weighing and Dispensing of Protein

• 4.1.2.1 Weigh the protein and any excipients using a calibrated balance.
• 4.1.2.2 Dispense the weighed protein into a sterile solvent (e.g., water for injection, WFI) following the formulation instructions.

4.1.3 Solubilization

• 4.1.3.1 Stir the solution gently to ensure complete solubilization of the protein without denaturation.
• 4.1.3.2 Avoid vigorous mixing to prevent foam formation and protein degradation.

4.2