SOP for Preparation of Lyophilized Allergen Extracts

Standard Operating Procedure for Preparation of Lyophilized Allergen Extracts

1) Purpose

This SOP outlines the procedure for preparing lyophilized allergen extracts, ensuring product stability and bioactivity during storage and reconstitution.

2) Scope

This SOP applies to all personnel involved in the preparation, testing, and quality control of lyophilized allergen extracts.

3) Responsibilities

Formulation Scientists: Responsible for selecting appropriate stabilizers and excipients to preserve allergenic proteins during lyophilization.
Operators: Responsible for preparing the allergen extracts as outlined in the Batch Manufacturing Record (BMR).
QA: Responsible for verifying bioactivity and stability and ensuring proper documentation.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Allergen Extract Stability

4.1.1.1 The formulation should ensure that the allergenic proteins remain bioactive and stable during lyophilization and storage.
4.1.1.2 Stabilizers such as sucrose or trehalose are often used to prevent protein degradation.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Weigh the required allergens and stabilizers as per the BMR.
4.2.1.2 Dissolve the allergens 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 Testing

4.3.1 Transfer the vials to the lyophilizer and follow the lyophilization cycle as specified in the BMR.
4.3.2 After lyophilization, perform reconstitution and bioactivity tests to ensure the allergen extract retains its efficacy.

4.4 Documentation

Record all steps in the Allergen Extract Lyophilization Logbook, including formulation preparation, filtration, and lyophilization parameters, and ensure QA verification.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Allergen Extract Lyophilization Logbook

7) References

Pharmacopoeial guidelines for allergen extract formulations

8) SOP Version

Version 1.0

Annexure

Allergen Extract Lyophilization Logbook Template


  
    Date
    Allergen Name
    Batch No.
    Stabilizer Used
    Bioactivity Test
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Allergen Name
    Batch Number
    Stabilizer Name
    Pass/Fail
    Operator Name
    QA Initials

Date	Allergen Name	Batch No.	Stabilizer Used	Bioactivity Test	Operator Initials	QA Verification
DD/MM/YYYY	Allergen Name	Batch Number	Stabilizer Name	Pass/Fail	Operator Name	QA Initials