Scientist, Biologics drug product development Sanofi Natick, Massachusetts
The talk is focused on establishing a mechanistic understanding of factors influencing fogging in lyophilized formulations. Vial fogging is a routinely encountered cosmetic defect in freeze-dried products. However, given that it hinders visual inspection and can lead to compromised container closure integrity, fogging above the shoulder and neck of the vial can result in high batch reject rates over inspection. This is of high relevance during clinical and commercial manufacturing. Fogging is influenced by a range of factors including formulation composition, processing conditions and primary packaging. Hence, a systematic study to investigate the influence of each of these factors on fogging enables a mechanistic understanding and consequently, the design of suitable mitigation strategies.
Learning Objectives:
Upon completion, participant will be able to define the fundamental concept of fogging.
Upon completion, participant will be able to list factors influencing fogging in lyophilized formulations.
Upon completion, participant will be able to demonstrate an in-depth understanding of suitable mitigation strategies.