Cycle design and optimization
The science-based approach to a better lyophilization process.
A suitable shelf-life, an elegant cake appearance and an economical lyophilization process are the desired goals during the development of a freeze-dried (bio)pharmaceutical drug product. Coriolis utilizes a science-based approach for the design and optimization of freeze-drying cycles. This approach is based on the knowledge of critical product temperatures of a specific formulation, which should not be exceeded during freeze-drying.
These temperatures – including the collapse temperature (Tc) and the glass transition temperature of the maximally freeze-concentrated solution (Tg´) – are determined by dedicated analytical techniques, such as the freeze-drying microscopy (FDM) and differential scanning calorimetry (DSC), respectively. Based on these temperatures appropriate process parameters are chosen.
All process parameters under control.
During the design of freeze-drying cylces, we define and optimize all critical process parameters specifically for each product. This allows us to achieve a robust process, a stable product and economical run times.
- Freezing rate
- Shelf temperature during freezing
- Duration of the freezing step
- Annealing step (depending on formulation composition)
Primary and secondary drying
- Shelf temperature
- Chamber pressure
- Ramp rate from freezing to primary drying
- Ramp rate from primary to secondary drying
- Duration of primary and secondary drying
- Stoppering pressure
- Type of gas used during stoppering
When optimizing freeze-drying cycles, our expert monitor and evaluate key parameters, including product temperature (Tp) during drying, shelf temperature (Ts) and chamber pressure (Pc). Our freeze-dryer equipment allows for in-process controls, where samples can be removed from the running processes by using a sample thief or through individual shelf closure mechanisms. This technology can also be used to generate products of different residual moisture content in one cycle.