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You are not familiar with the basic principles of “freeze drying”? Click here to read a short introduction and learn how freeze drying works.


Freeze Drying of Pharmaceuticals and Biologicals - the Rational Approach:

Freeze drying of pharmaceuticals and biologicals is sometimes a complex and difficult undertaking. In the first step, a formulation for a given active pharmaceutical ingredient (API) needs to be designed according to the API “needs”. This, however, requires sound knowledge about (1) chemical and physical instabilities of the API (small molecule or protein, peptide), (2) the different excipients frequently used to stabilize the API structure and (3) analytical tools to identify the degree of the API degradation. The second step includes the application of thermo analytical methods (e.g. freeze-dry microscopy, differential scanning calorimetry, etc.) which are very important to determine the “critical temperature” of the formulation. Based on step one and two, the freeze drying run can be  optimized for a given formulation, including the testing of “robustness” of a cycle (Design Space). During this step new process analytical technology (PAT) tools may help to identify and to quantify critical process parameters during primary and secondary drying, including end point detection. The last step is the challenge to scale-up the recipe developed in the laboratory to a production unit (commercial scale freeze drying) which requires fundamental knowledge about heat and mass transfer. Parallel to the freeze drying cycle development, attributes of the final freeze dried product have to be characterized. This information might be critical to predict long term storage (e.g. residual moisture by Karl-Fischer, stability of the API by FTIR, in some cases the overall crystallinity of the product by X-ray, etc.).

As a summary, the different freeze drying steps should not be handled as “individual” phases, rather than a unity of operations that require sound scientific background information in both the formulation and engineering part.    




Our Research Interests:

Our research group focuses on a variety of different aspects in the field of freeze drying. Our projects are currently focussed on:

  #1: Freeze-Dry Microscopy (FDM)

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  #2: New Process Analytical Technology (PAT) Tools For Freeze Drying                

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  #3: Freeze Drying Process Development And Process Transfer

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  #4: Freeze Drying Process Design When Using non-Vial Container Systems

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  #5: Freeze Drying Of Nanomaterials

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Besides ongoing research projects, we are always looking for industrial partners or academic groups to share ideas or to set up a joint project. Do not hesitate to contact us! 

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