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 Addition of Stabilizers
4.2.1 Weighing and Adding Stabilizers
- 4.2.1.1 Weigh the appropriate amount of stabilizer as per the BMR and add it to the protein solution.
- 4.2.1.2 Ensure that the stabilizer is fully dissolved and properly mixed to protect the protein during lyophilization.
4.3 Filtration of the Solution
- 4.3.1 Filter the protein solution through a 0.22-micron sterile filter to remove particulates and ensure sterility.
- 4.3.2 Transfer the filtered solution into sterile containers labeled with the batch number, date, and formulation details.
4.4 Documentation
All activities, including the weighing, preparation, and filtration steps, must be documented in the Protein-Based Formulation Logbook, with verification from the QA team.
5) Abbreviations
- BMR: Batch Manufacturing Record
- WFI: Water for Injection
6) Documents
- Protein-Based Formulation Logbook
7) References
- Guidelines on Protein Stability and Lyophilization (ICH Q5C, USP)
8) SOP Version
Version 1.0
Annexure
Protein-Based Formulation Logbook Template
| Date | Protein Name | Batch No. | Stabilizer | Solubilized Volume | pH | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Protein Name | Batch Number | Stabilizer Name | Volume in mL | pH Value | Operator Name | QA Initials |