An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

ABSTRACT Concern around the lack of monitoring of proteinaceous subvisible particulates in the 0.1–10 mm range has been heightened (Carpenter et al., 2009, J Pharm Sci 98: 1202–1205), primarily due to uncertainty around the potential immunogenicity risk from these particles. This article, representing the opinions of a number of industry scientists, aims to further the discussion by developing a common understanding around the technical capabilities, limitations, as well as utility of monitoring this size range; reiterating that the link between aggregation and clinical immunogenicity has not been unequivocally established; and emphasizing that such particles are present in marketed products which remain safe and efficacious despite the lack of monitoring. Measurement of subvisible particulates in the