3. Optimization and control of operating procedures

Given the high added value and marginal stability (maximum Gibbs energy variation of a few kcal/mol) of biopharmaceutical products used in new treatments (new biomolecules, new forms of administration), freeze-drying has become a frequent and necessary, albeit costly, operation to ensure preservation of the active ingredient until administration to the patient. To reduce the overall cost of treatment, it is therefore necessary to reduce the cost of lyophilization by optimizing the operating parameters. The sublimation stage (primary drying) is by far the longest (> 24 hours) and the most costly, as it requires low-temperature, low-pressure operation, which implies high energy consumption. A great deal of research is still being carried out to optimize the parameters related to the duration of this stage. These parameters are of different natures and do not only concern the sublimation...