Standard Operating Procedure for Incorporation of Immunomodulators in Lyophilized Products

1) Purpose

This SOP outlines the procedure for incorporating immunomodulators into lyophilized products to enhance immune response while ensuring product stability and bioactivity during lyophilization.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized products containing immunomodulators.

3) Responsibilities

• Formulation Scientists: Responsible for selecting immunomodulators and ensuring their compatibility with the lyophilization process.
• Operators: Responsible for incorporating immunomodulators as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the incorporation of immunomodulators and ensuring proper documentation.

4) Procedure

4.1 Selection of Immunomodulators

4.1.1 Criteria for Selection

• 4.1.1.1 Immunomodulators should be compatible with the active ingredient and not degrade during lyophilization. Commonly used agents include cytokines, adjuvants, or other immune-enhancing compounds.

4.2 Incorporation of Immunomodulators

4.2.1 Weighing and Dispensing

• 4.2.1.1 Weigh the immunomodulators using a calibrated balance as specified in the BMR.
• 4.2.1.2 Dissolve the immunomodulators in a suitable buffer solution and mix into the formulation.

4.2.2 Mixing and Homogenization

• 4.2.2.1 Stir the solution using a mechanical stirrer to ensure even distribution of the immunomodulators.
• 4.2.2.2 Homogenize the mixture if necessary to ensure uniformity.

4.3 Filtration and Filling

• 4.3.1 Filter the formulation using a sterile 0.22-micron filter and fill