Standard Operating Procedure for Preparation of Lyophilized Allergen Extracts

1) Purpose

This SOP outlines the procedure for preparing lyophilized allergen extracts, ensuring product stability and bioactivity during storage and reconstitution.

2) Scope

This SOP applies to all personnel involved in the preparation, testing, and quality control of lyophilized allergen extracts.

3) Responsibilities

• Formulation Scientists: Responsible for selecting appropriate stabilizers and excipients to preserve allergenic proteins during lyophilization.
• Operators: Responsible for preparing the allergen extracts as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying bioactivity and stability and ensuring proper documentation.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Allergen Extract Stability

• 4.1.1.1 The formulation should ensure that the allergenic proteins remain bioactive and stable during lyophilization and storage.
• 4.1.1.2 Stabilizers such as sucrose or trehalose are often used to prevent protein degradation.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

• 4.2.1.1 Weigh the required allergens and stabilizers as per the BMR.
• 4.2.1.2 Dissolve the allergens in a suitable buffer and stir until fully dissolved.

4.2.2 Sterile Filtration and Filling

• 4.2.2.1 Filter the solution through a sterile 0.22-micron filter to ensure sterility.
• 4.2.2.2 Aseptically fill the vials and freeze at -80°C before lyophilization.

4.3 Lyophilization and Testing

• 4.3.1 Transfer the vials to the lyophilizer and follow the lyophilization cycle as specified in the BMR.
• 4.3.2