Contract Services

Contract Lyophilization

Lyophilization, or freeze-drying is a method used to remove moisture from a product to improve stability, lengthen shelf-life, reduce volume and weight of the product and also maintain sterility during transport and storage.
At very low pressure and low temperature, water is taken out of the container using sublimation, without damaging the material.
Serana has the expertise and resources to optimise the lyophilization process of your products.

1) Cycle Development

Cycle development begins with understanding the critical temperatures ofthe formulation by utilizing:
  • Modulated Differential Scanning Calorimetry (mDSC)
  • Freeze Dry Microscopy (FDM)
Once we have determined the thermal properties of your formulated product, we use the following data sets:
  • Glass Transition Temperature (Tg)
  • Eutectic Temperature (Te)
  • Collapse Temperature (Tc)
  • Re-crystallization Temperature (Tcry)
This is in order to develop the nominal drying conditions for the lyophilization cycle parameters.

2) Intentional Collapse

To deliver a commercially robust lyophilization process and ensure the finished product consistently meets the finished product CQAs at release, we perform an “Intentional Collapse Study” (ICS) during the final stages of lyophilization development. The Process Development team will perform the ICS study to intentionally collapse the product to fully understand the potential points of failure in the lyophilization cycle.

3) Cycle Optimization

Life cycling the nominal lyophilization cycle parameters, we will specifically optimize the lyophilization cycle for your product, optimizing for low residual moisture, cake appearance, reconstitution, and total run time. Optimizing the cycle for total run time can lead to cost efficiencies over the life-cycle of your product.

4) Lyophilization Equipment

Our freeze dryer is suitable for applications in the field of research and development, as well as small-scale production. The free-standing unit has an ice capacity of 10 kg and a footprint of up to 1.2 m².

Contact our Sales team to discuss how we can help you.

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