SOP for Preparation of Lyophilized Enzyme Products

Standard Operating Procedure for Preparation of Lyophilized Enzyme Products

1) Purpose

This SOP outlines the procedure for preparing lyophilized enzyme products to maintain enzyme stability and bioactivity during freeze-drying and subsequent storage.

2) Scope

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

3) Responsibilities

Formulation Scientists: Responsible for selecting stabilizers and buffers to maintain enzyme stability and activity during lyophilization.
Operators: Responsible for preparing the enzyme solution as per the Batch Manufacturing Record (BMR).
QA Personnel: Responsible for validating enzyme activity post-lyophilization and ensuring proper documentation.

4) Procedure

4.1 Enzyme Formulation

4.1.1 Criteria for Enzyme Stability

4.1.1.1 The formulation must protect the enzyme from denaturation and loss of activity during freeze-drying. Common stabilizers such as sugars (e.g., sucrose, trehalose) or polyols (e.g., glycerol) may be used.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Weigh the enzyme and stabilizers accurately as per the BMR.
4.2.1.2 Dissolve the enzyme in a suitable buffer, ensuring that it is fully dissolved and that the stabilizers are evenly dispersed.

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 solution, ensuring accurate fill volumes

as per the BMR.

4.2.2.3 Freeze the vials at -80°C before proceeding with the lyophilization cycle.

4.3 Lyophilization and Post-Lyophilization Testing

4.3.1 Load the frozen vials into the lyophilizer and initiate the freeze-drying cycle as specified in the BMR.
4.3.2 After lyophilization, reconstitute the enzyme product and perform enzyme activity assays to ensure bioactivity is retained.

4.4 Documentation

Record all steps, including solution preparation, filtration, and post-lyophilization testing, in the Enzyme Product Lyophilization Logbook. Ensure that all records are verified by QA.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Enzyme Product Lyophilization Logbook

7) References

Pharmacopoeial guidelines for enzyme product formulation and testing

8) SOP Version

Version 1.0

Annexure

Enzyme Product Lyophilization Logbook Template


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

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