Abstract:
:Biopharmaceuticals represent an important and growing class of medicines. Immunogenic responses to biopharmaceuticals in patients can sometimes result in reduced safety and efficacy. Although multiple factors are known to influence immunogenicity, our understanding of the complex underlying mechanisms remains imperfect. In particular, the potential impact of protein aggregates (particulates) on immunogenicity is currently not well understood. This commentary discusses emerging technologies for particle assessment, what is known about the link between particulates and product safety and efficacy, and current regulatory guidances and perspectives. We consider approaches that in the future may permit specific particle attributes to be correlated with relative immunogenic risk, including the value of data derived from clinical and postmarketing surveillance. Finally, we identify some key remaining questions, which, when answered, may guide future strategies for decreasing the immunogenicity of biopharmaceuticals.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Bee JS,Goletz TJ,Ragheb JAdoi
10.1002/jps.23247subject
Has Abstractpub_date
2012-10-01 00:00:00pages
3580-5issue
10eissn
0022-3549issn
1520-6017pii
S0022-3549(15)31382-4journal_volume
101pub_type
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