SOP for Preparation of Lyophilized Biologics

Standard Operating Procedure for Preparation of Lyophilized Biologics

1) Purpose

This SOP outlines the process for preparing lyophilized biologics, ensuring product stability, bioactivity, and proper storage conditions.

2) Scope

This SOP applies to all personnel involved in the formulation, preparation, and testing of biologics that undergo lyophilization for long-term storage and transport.

3) Responsibilities

Formulation Scientists: Responsible for selecting suitable stabilizers and cryoprotectants to preserve the bioactivity of biologics during lyophilization.
Operators: Responsible for preparing the biologics for lyophilization according to the Batch Manufacturing Record (BMR).
QA: Responsible for verifying bioactivity, stability, and proper documentation of the lyophilized biologics.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Biologics Stability

4.1.1.1 The formulation should ensure that the biologics retain their bioactivity and do not aggregate during lyophilization.
4.1.1.2 Stabilizers such as sugars (e.g., sucrose or trehalose) and proteins (e.g., albumin) are commonly used to prevent degradation.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Weigh the required ingredients and biologics according to the BMR.
4.2.1.2 Dissolve the biologics 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 Reconstitution Testing

4.3.1 Transfer the vials to the lyophilizer and

run the lyophilization cycle as specified in the BMR.

4.3.2 After lyophilization, reconstitute the biologics and test for bioactivity using appropriate assays.

4.4 Documentation

Record all steps in the Lyophilized Biologics Logbook, including formulation preparation, filtration, and lyophilization parameters, and ensure QA verification.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Lyophilized Biologics Logbook

7) References

Pharmacopoeial guidelines for biologic drug formulations

8) SOP Version

Version 1.0

Annexure

Lyophilized Biologics Logbook Template


  
    Date
    Biologics Name
    Batch No.
    Bioactivity Test
    Stability Test
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Biologics Name
    Batch Number
    Pass/Fail
    Pass/Fail
    Operator Name
    QA Initials

Date	Biologics Name	Batch No.	Bioactivity Test	Stability Test	Operator Initials	QA Verification
DD/MM/YYYY	Biologics Name	Batch Number	Pass/Fail	Pass/Fail	Operator Name	QA Initials