Contract Services

Contract Lyophilization

Lyophilization, also known as freeze-drying, is a process used to preserve perishable materials by removing the water or other solvents from the material. This is done by freezing the material and then applying a high vacuum, which causes the frozen water in the material to sublimate (transition directly from a solid to a gas) and be removed.

Lyophilization is commonly used to preserve biological materials such as blood plasma, vaccines, and enzymes, as well as food and pharmaceutical products. It is a useful preservation method because it allows the material to retain its original form, structure, and biological activity after the water has been removed.

This makes lyophilized materials stable and easy to store and transport, while also maintaining their quality and potency. Lyophilization is also a versatile process that can be used on a wide range of materials, making it a valuable tool in many different industries.

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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