NEWS

Health Check Your Freeze Drying Processes
 

Our new LyoHealth Check service is designed to identify the optimal parameters for freeze drying your product. It will enable you to evaluate existing risks and design a roadmap for process optimisation. You will benefit from the Lyohealth Check service if you are:-

• Currently preparing a regulatory submission; the LyoHealth Check will provide the supporting data to justify your chosen process
• Seeking to optimise an existing process; the Lyohealth Check will reveal where there is scope to shorten your cycle time and increase the efficiency of your process
• Encountering difficulties in development. The Lyohealth Check will give you the insights to produce freeze dried product that meets your ideal performance specification

A Lyohealth Check early in the process development phase can save valuable time and ensure that your project plan remains on track.

Through the Lyohealth Check you will gain access to BTL’s expert analytical systems Lyotherm2 and Lyostat2 and skilled staff. Our scientists will undertake detailed analyses to characterise your freeze dried product, and document their findings and recommendations in a report. You will receive copies of all data that are generated in the course of the analyses.

Freeze drying microscopy
This form of analysis is used to pinpoint key events within your formulation such as the collapse temperature. Product collapse is not always clearly visible and yet can lead to severely reduced activity, inefficient reconstitution and shorter shelf life. Identification of these critical temperatures with the Lyostat2 freeze drying microscope can help you redesign your cycle to be more robust, more efficient, or as validatory evidence of the success of your cycle.

Impedance and differential thermal analysis
Our custom-designed Lyotherm2 thermal analyser provides information about the behaviour of your formulation in the frozen state. Lyotherm2 can indentify changes in molecular mobility and indicate thermal events e.g. crystallisation. This is important to verify that your formulation is not undergoing any adverse changes during the freeze drying process.

Moisture Analysis
Karl Fisher moisture analysis is used to establish how much moisture really remains in your product after processing. This analysis demonstrates the success and efficiency of the overall freeze drying process.

Differential Scanning Calorimetry
Modulated DSC analysis enables us to analyse the final freeze dried product and identify any glass transitionas, thereby indicating safe storage temperatures. The glass transition temperature is the point at which the dried product may soften and lose structure, resulting in poor long term stability and loss of activity.

For more information contact Tom Peacock or Marc Townell at btl@biopharma.co.uk

Links
Installation at University of Iowa
BTL at the BPC 2009
Download September newsletter as a pdf

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