December 15, 2019
Combining a purpose-built facility and experienced development scientists
- Pilot scale facility with relevant technology, equivalent to those used in GMP Stages.
- Challenge of complex aspects of the formulation, such as temperature, viscosity, contact with
materials that could induce aggregation or other changes in the molecule.
- Simulation of formulation, filling, lyophilization and closing procedures.
- Design space calculation based on DoE and other Six Sigma tools.
- Engineering, stability, and validation batches and previous physico-chemical characterization.
- All in-house validation support.