Cycle design and optimization

lyophilization_development

The science-based approach to a better lyophilization process.

    Lyophilization freeze-drying cycle design and optimization

    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.

    Freeze-dried, Lyophilized drug product

    Freezing

    • 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 conditions

    • Stoppering pressure
    • Vacuum
    • 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.

    Get in contact with out experts today and find out how we can optimize your lyophilization process.

      Contact us

      Contact us

      For enquiries related to lyophilized formulations please contact Dr. Matthias Lucke

      Dr. Matthias Lucke