The presentation will include an introduction and explanation of the reasons for the broader use of CSTDs with biologics. The differences in the design and materials of different devices will also be explained. Further, experimental data showing the effect of various features of CSTDs on protein drug quality attributes like the presence of visible particles and the number and size of subvisible particles will be presented. An overview of potential sources of issues during the use of CSTDs for biologics and strategies for risk mitigation will conclude the talk. This presentation is a part of a 2-hr symposium under the general title "Can you handle it? Postproduction handling and administration of biologics" Moderator suggestion: Sreedhara Alavattam, Principal Scientist at Genentech
Upon completion, participants will be able to list the advantages and concerns related to the use of CSTDs for biologics.
Upon completion, participants will be able to describe the primary sources of protein stability concerns arising from CSTDs and their potential effects on critical attributes of proteinaceous drugs.
Upon completion, participants will be able to propose mitigation strategies for the safe use of CSTDs with biologics.