Gilyos Services
Gilyos Service

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.

Gilyos Service
Gilyos Slide
Gilyos Slide 339Gilyos Slide 341Gilyos Slide 345Gilyos Slide 347Gilyos Slide 349Gilyos Slide 351Gilyos Slide 353Gilyos Slide 355Gilyos Slide 357Gilyos Slide 359Gilyos Slide 361Gilyos Slide 365Gilyos Slide 367
Gilyos Slide