The formulation development program, initiated earlier this year, was based on material from the technical batch produced at 3P Biopharmaceuticals during late spring and has included extensive testing of different conditions to optimize TOL2 drug product characteristics. Multiple parameters such as pH, ionic strength, buffers, excipients, and concentrations of TOL2 have been varied in either a frozen or a freeze-dried format to obtain a final drug product with optimized properties for storage, reconstitution, and stability. The work has been completed by Toleranzia´s Danish partners
The final formulated drug product comprises a freeze-dried TOL2 that can be stably stored and reconstituted at a high concentration of active drug. The long-term stability is currently being investigated to determine the drug product shelf life, which is expected to be at least two years – fully sufficient for the clinical program. In addition to this, freeze-dried TOL2 drug product has successfully been prepared from the technical batch, to be used in the GLP-toxicology study at
“I am very pleased to conclude that our Danish partners have conducted an exemplary formulation development program resulting in a final freeze-dried TOL2 drug product with excellent characteristics in terms of handling, storage, and stability. This freeze-dried drug product formulation has come to immediate use in the preparations of the GLP-toxicology study which we will initiate in mid-September together with our partner
For further information, please contact:
Tel: +46 763 19 98 98
Email: charlotte.fribert@toleranzia.com
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