Gilyos Services
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Quality by Design (QbD) in Freeze-Drying

Dr. Henning Gieseler, CEO of GILYOS, is one of the pioneers in the field of QbD in freeze-drying. His habilitation thesis entitled “Quality by Design (QbD) in Freeze-Drying Using Advanced Process Analytical Technology (PAT)” highlights the importance of the interrelationship between product and process attributes in freeze-drying science. Important factors are, for example, the rational design of a cycle robustness testing protocol for freeze-dried products and the evaluation of the process design space.

GILYOS offers individualized support when implementation of a QbD concept for freeze-drying is desired. As part of a development alliance, we can further support customers in cases where a final PAT drug product submission filing is targeted.

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