SOP for Lyophilization of Live Attenuated Vaccines

Standard Operating Procedure for Lyophilization of Live Attenuated Vaccines

1) Purpose

This SOP outlines the procedure for lyophilizing live attenuated vaccines to ensure the stability and viability of the vaccine during storage and transport.

2) Scope

This SOP applies to all personnel involved in the formulation, preparation, and testing of live attenuated vaccines that undergo lyophilization, including formulation scientists, operators, and QA personnel.

3) Responsibilities

Formulation Scientists: Responsible for selecting cryoprotectants and other excipients to preserve vaccine viability during lyophilization.
Operators: Responsible for preparing the vaccine solution as per the Batch Manufacturing Record (BMR).
QA Personnel: Responsible for verifying vaccine stability, potency, and documentation post-lyophilization.

4) Procedure

4.1 Selection of Cryoprotectants

4.1.1 Criteria for Vaccine Stability

4.1.1.1 Cryoprotectants such as trehalose or sucrose are often added to protect the live attenuated virus during freeze-drying and storage.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Accurately weigh the required vaccine components and cryoprotectants according to the BMR.
4.2.1.2 Dissolve the vaccine components in a suitable buffer and stir to ensure 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 sterile vials with the filtered vaccine solution and freeze the vials at -80°C to prepare for lyophilization.

4.3 Lyophilization and Post-Lyophilization Testing

4.3.1 Transfer the

frozen vials to the lyophilizer and initiate the freeze-drying cycle as specified in the BMR.

4.3.2 After lyophilization, reconstitute the vaccine and test for virus viability and potency using appropriate assays.

4.4 Documentation

Record all steps, including vaccine preparation, filtration, lyophilization, and post-lyophilization testing, in the Vaccine Lyophilization Logbook. QA personnel must verify all records.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Vaccine Lyophilization Logbook

7) References

Pharmacopoeial guidelines for live attenuated vaccines and lyophilization processes

8) SOP Version

Version 1.0

Annexure

Vaccine Lyophilization Logbook Template


  
    Date
    Vaccine Name
    Batch No.
    Cryoprotectant Used
    Virus Viability Test
    Potency Test
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Vaccine Name
    Batch Number
    Cryoprotectant Name
    Pass/Fail
    Pass/Fail
    Operator Name
    QA Initials

Date	Vaccine Name	Batch No.	Cryoprotectant Used	Virus Viability Test	Potency Test	Operator Initials	QA Verification
DD/MM/YYYY	Vaccine Name	Batch Number	Cryoprotectant Name	Pass/Fail	Pass/Fail	Operator Name	QA Initials