Standard Operating Procedure for Lyophilization of Blood Products and Plasma Derivatives

1) Purpose

This SOP outlines the method for the lyophilization of blood products and plasma derivatives to ensure stability during long-term storage and transport.

2) Scope

This SOP applies to personnel involved in the formulation, preparation, and testing of blood products and plasma derivatives for lyophilization, including formulation scientists, operators, and QA personnel.

3) Responsibilities

• Formulation Scientists: Responsible for selecting excipients and stabilizers that protect proteins and other plasma components during freeze-drying.
• Operators: Responsible for preparing the blood or plasma product for lyophilization according to the Batch Manufacturing Record (BMR).
• QA Personnel: Responsible for verifying product stability, safety, and proper documentation post-lyophilization.

4) Procedure

4.1 Selection of Stabilizers

4.1.1 Criteria for Stability

• 4.1.1.1 Stabilizers such as albumin or sugars (e.g., sucrose) are often added to protect plasma proteins and other components from degradation during lyophilization.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

• 4.2.1.1 Weigh the required stabilizers and plasma products accurately as per the BMR.
• 4.2.1.2 Dissolve the plasma product in a suitable buffer and stir gently to ensure homogeneity and complete dissolution of stabilizers.

4.2.2 Sterile Filtration and Filling

• 4.2.2.1 Filter the solution through a sterile 0.22-micron filter to remove particulates.
• 4.2.2.2 Aseptically fill sterile vials with the filtered