Standard Operating Procedure for Preparation of Lyophilized DNA and RNA Formulations
1) Purpose
This SOP outlines the procedure for preparing lyophilized DNA and RNA formulations to ensure the stability and preservation of genetic material during storage and transportation.
2) Scope
This SOP applies to all personnel involved in the preparation, handling, and testing of lyophilized DNA and RNA formulations, including formulation scientists, production operators, and QA personnel.
3) Responsibilities
- Formulation Scientists: Responsible for selecting appropriate stabilizers and excipients to protect nucleic acids during lyophilization.
- Operators: Responsible for the preparation and lyophilization of DNA/RNA formulations as outlined in the Batch Manufacturing Record (BMR).
- QA: Responsible for ensuring proper documentation and verification of lyophilization parameters.
4) Procedure
4.1 Formulation Development
4.1.1 Criteria for DNA/RNA Stability
- 4.1.1.1 The formulation should ensure the stability of DNA/RNA during freeze-drying and long-term storage.
- 4.1.1.2 Stabilizers such as trehalose, sucrose, or other cryoprotectants are commonly used to prevent degradation.
4.2 Preparation and Lyophilization
4.2.1 Solution Preparation
- 4.2.1.1 Weigh the required nucleic acids and stabilizers as specified in the BMR.
- 4.2.1.2 Dissolve the DNA or RNA in a suitable buffer, such as Tris-EDTA, 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 run the lyophilization cycle as specified in the BMR.
- 4.3.2 After lyophilization, test the reconstituted product for DNA/RNA integrity and functional activity using appropriate assays.
4.4 Documentation
Record all steps in the DNA/RNA Lyophilization Logbook, including formulation preparation, filtration, and lyophilization parameters, and ensure QA verification.
5) Abbreviations
- BMR: Batch Manufacturing Record
- Tris-EDTA: Tris(hydroxymethyl)aminomethane – Ethylenediaminetetraacetic acid
6) Documents
- DNA/RNA Lyophilization Logbook
7) References
- Scientific literature on DNA and RNA stabilization techniques during lyophilization
8) SOP Version
Version 1.0
Annexure
DNA/RNA Lyophilization Logbook Template
| Date | DNA/RNA Type | Batch No. | Stabilizer Used | Integrity Testing | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | DNA/RNA Type | Batch Number | Stabilizer Name | Pass/Fail | Operator Name | QA Initials |