Standard Operating Procedure for Preparation of Monoclonal Antibody Lyophilized Formulations
1) Purpose
This SOP outlines the procedure for the preparation of monoclonal antibody (mAb) formulations intended for lyophilization, ensuring that the mAbs maintain stability, efficacy, and bioactivity throughout the process.
2) Scope
This SOP applies to all personnel involved in the preparation of monoclonal antibody formulations for lyophilized products, including formulation scientists, production operators, and QA personnel.
3) Responsibilities
- Formulation Scientists: Responsible for designing the monoclonal antibody formulation and selecting appropriate stabilizers and excipients.
- Operators: Responsible for preparing the mAb solution according to the Batch Manufacturing Record (BMR).
- QA: Responsible for verifying the process and ensuring proper documentation is maintained.
4) Procedure
4.1 Preparation of Monoclonal Antibody Solution
4.1.1 Equipment Setup
- 4.1.1.1 Ensure that all equipment (e.g., mixers, pH meters, balances) is cleaned, sanitized, and calibrated before use.
- 4.1.1.2 Prepare sterile containers for the mAb solution and maintain aseptic conditions throughout the preparation process.
4.1.2 Weighing and Dispensing
- 4.1.2.1 Weigh the required amount of monoclonal antibodies and excipients using a calibrated balance.
- 4.1.2.2 Dissolve the mAb in a suitable buffer solution (e.g., phosphate buffer) according to the BMR.
4.1.3 pH Adjustment
- 4.1.3.1 Use a calibrated pH meter to check the pH of the solution.
- 4.1.3.2 Adjust the pH using small amounts of acid or base if necessary, ensuring the pH is within the specified range for optimal stability.
4.2 Addition of Stabilizers
4.2.1 Weighing and Addition
- 4.2.1.1 Weigh the appropriate amount of stabilizers (e.g., trehalose or sucrose) as per the formulation.
- 4.2.1.2 Add the stabilizer to the monoclonal antibody solution and mix gently until fully dissolved.
4.3 Filtration and Filling
4.3.1 Filtration
- 4.3.1.1 Filter the monoclonal antibody solution using a sterile 0.22-micron filter to remove particulates.
4.3.2 Filling
- 4.3.2.1 Fill sterile vials with the filtered mAb solution under aseptic conditions, ensuring each vial contains the correct volume as per the BMR.
4.4 Lyophilization
Transfer the filled vials to the lyophilizer and follow the lyophilization cycle as specified in the BMR, ensuring that the cycle parameters (e.g., temperature, pressure) are within the specified ranges.
4.5 Documentation
All steps, including weighing, pH adjustment, filtration, and lyophilization parameters, must be recorded in the Monoclonal Antibody Lyophilization Logbook and verified by QA.
5) Abbreviations
- mAb: Monoclonal Antibody
- BMR: Batch Manufacturing Record
6) Documents
- Monoclonal Antibody Lyophilization Logbook
7) References
- Scientific articles on monoclonal antibody stabilization and lyophilization techniques
8) SOP Version
Version 1.0
Annexure
Monoclonal Antibody Lyophilization Logbook Template
| Date | Monoclonal Antibody Name | Batch No. | pH | Stabilizer | Volume Filled | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | mAb Name | Batch Number | pH Value | Stabilizer Name | Volume in mL | Operator Name | QA Initials |