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