The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: A shared perspective

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 mechanis...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2012-10, Vol.101 (10), p.3580-3585
Main Authors: Bee, Jared S., Goletz, Theresa J., Ragheb, Jack A.
Format: Article
Language:English
Subjects:
Animals
Antibody Formation - immunology
Biological and medical sciences
Biological Products - adverse effects
Biological Products - immunology
Biological Products - pharmacology
Biological Products - therapeutic use
biotechnology
Drug-Related Side Effects and Adverse Reactions
General pharmacology
Humans
immunology
Medical sciences
microparticles
nanoparticles
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Product Surveillance, Postmarketing
protein aggregation
protein formulation
Proteins - adverse effects
Proteins - immunology
Proteins - pharmacology
Proteins - therapeutic use
regulatory science
Risk Assessment - methods
Safety
stability
therapeutic drug monitoring
Vaccines, Synthetic - adverse effects
Vaccines, Synthetic - immunology
Vaccines, Synthetic - pharmacology
Vaccines, Synthetic - therapeutic use
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Summary: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. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:3580–3585, 2012
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.23247