Standard Operating Procedure for Preparation of Lyophilized Peptide Therapeutics
1) Purpose
This SOP outlines the procedure for preparing lyophilized peptide therapeutics, ensuring that the bioactivity and stability of the peptide is maintained during lyophilization and storage.
2) Scope
This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized peptide therapeutics, including formulation scientists, production operators, and QA personnel.
3) Responsibilities
- Formulation Scientists: Responsible for selecting stabilizers and optimizing the peptide formulation to ensure stability.
- Operators: Responsible for preparing the peptide solution as outlined in the Batch Manufacturing Record (BMR).
- QA: Responsible for verifying bioactivity and stability after lyophilization.
4) Procedure
4.1 Formulation Development
4.1.1 Criteria for Peptide Stability
- 4.1.1.1 The peptide formulation must ensure that the bioactivity of the peptide is retained during lyophilization and storage.
- 4.1.1.2 Stabilizers such as sugars (e.g., trehalose) or amino acids may be added to prevent peptide degradation.
4.2 Preparation and Lyophilization
4.2.1 Solution Preparation
- 4.2.1.1 Weigh the required peptide and stabilizers according to the BMR.
- 4.2.1.2 Dissolve the peptide in a suitable buffer, ensuring full dissolution and 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 the vials with the peptide solution and freeze at -80°C before starting the lyophilization cycle.
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 peptide using a suitable diluent and perform bioactivity tests to ensure functionality is retained.
4.4 Documentation
Record all steps, including peptide solution preparation, filtration, and lyophilization parameters, in the Peptide Therapeutic Lyophilization Logbook. Ensure that QA verifies all reconstitution and bioactivity test results.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Peptide Therapeutic Lyophilization Logbook
7) References
- Pharmacopoeial guidelines for peptide stability and bioactivity testing in lyophilized formulations
8) SOP Version
Version 1.0
Annexure
Peptide Therapeutic Lyophilization Logbook Template
| Date | Peptide Name | Batch No. | Stabilizer Used | Reconstitution Test | Bioactivity Test | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Peptide Name | Batch Number | Stabilizer Name | Pass/Fail | Pass/Fail | Operator Name | QA Initials |