Standard Operating Procedure for Formulation of Lyophilized Vaccines

1) Purpose

The purpose of this SOP is to describe the process of formulating vaccines for lyophilization to preserve their potency, safety, and efficacy during storage and transport.

2) Scope

This SOP applies to all personnel involved in the formulation of lyophilized vaccines, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

• Formulation Scientists: Responsible for developing the vaccine formulation, including the selection of stabilizers and cryoprotectants.
• Operators: Responsible for following the formulation process as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the accuracy of the formulation process and ensuring documentation is complete.

4) Procedure

4.1 Preparation of Vaccine Solution

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment used for formulation (e.g., mixers, filtration systems) is sanitized and calibrated.
• 4.1.1.2 Use sterilized containers and maintain aseptic conditions throughout the process.

4.1.2 Vaccine Preparation

• 4.1.2.1 Weigh the active component (antigen) and excipients as per the formulation instructions.
• 4.1.2.2 Dissolve the antigen in a sterile solvent (e.g., saline, WFI) and mix gently to avoid denaturation.
• 4.1.2.3 Add stabilizers and cryoprotectants to protect the vaccine during the lyophilization process.

4.2 Filtration and Filling

4.2.1 Filtration

• 4.2.1.1 Filter the prepared vaccine solution using a 0.22-micron sterile filter to remove any particulates.

4.2.2 Filling