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Critical Factors in the Design and Optimisation of Lyophilisation Processes

The large number of variables at play in the lyophilisation process necessitates that it will remain as much an art as a science; however, as the science becomes better understood, the art can be analysed, categorised and repeated with greater accuracy.

Lisa M Hardwick, Christine Paunicka and Michael J Akers at Baxter BioPharma Solutions (October 2008)

Keywords: Supportable, sublimation rate, Cycle development, Validation of commercial batches

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