Standard Operating Procedure for Formulating Lyophilized Cancer Therapeutics

1) Purpose

This SOP outlines the procedure for formulating lyophilized cancer therapeutics, ensuring the stability and efficacy of the active pharmaceutical ingredient (API) during lyophilization and storage.

2) Scope

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

3) Responsibilities

• Formulation Scientists: Responsible for designing the formulation and selecting excipients that stabilize the API during lyophilization.
• Operators: Responsible for preparing the formulation as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the stability and integrity of the product during and after lyophilization.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Cancer Therapeutics

• 4.1.1.1 The formulation must preserve the bioactivity of the therapeutic while ensuring a controlled release or targeted delivery.
• 4.1.1.2 Common excipients include cryoprotectants like trehalose and mannitol, which prevent protein aggregation during freezing.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

• 4.2.1.1 Weigh the required ingredients and active pharmaceutical ingredients (API) as per the BMR.
• 4.2.1.2 Dissolve the ingredients in a suitable solvent and stir until fully dissolved, ensuring homogeneity.

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