Dr. Madeleine Witting holds a degree in Pharmacy / Pharmaceutical Technology from Ludwig-Maximilians-University, Munich, Germany.
She is an experienced Senior Scientist in the Process Engineering Sciences section and leads the freeze-drying development group at AbbVie, Germany.
Among others, she specializes in the development and manufacturing of customized freeze-drying processes, process transfer from small to pilot scale, and in freeze-drying simulation/ modeling.
“Fogging” of the vial is a phenomenon often observed in freeze-drying. The formation of a dry powder haze, that sometimes also can show fingering or branching patterns, is primarily a cosmetic defect based on Marangoni flow that can become critical, when product is enclosed between stopper and vial neck. As a result, container closure integrity as well as dosing accuracy can be negatively influenced, leading to quite variable and unpredictable reject rates. In this case study the investigation process towards fogging mitigation for a therapeutic antibody is presented.View Details