Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products

Journal of Pharmaceutical Sciences

Volumn 101, Issue 10, 2012, Pages 3555-3559

  Marszal, Ewa ^a   Fowler, Elizabeth ^b  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b CMC Consulting Services   (United States)

Author keywords

Immunology; Injectables; Particle size; Physical characterization; Physical stability; Protein aggregation

Indexed keywords

DRUG; NEUTRALIZING ANTIBODY; SILICONE;

ADVERSE OUTCOME; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; DISEASE COURSE; FLOW CYTOMETRY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNE SYSTEM; IMMUNOGENICITY; NOTE; PARTICLE SIZE; PRODUCT SAFETY; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN STRUCTURE; TREATMENT FAILURE; WORKSHOP;

EID: 84865353635     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23243     Document Type: Note

References (4)

1. Rosenberg AS, Verthelyi D, Cherney BW. 2012. Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins. J Pharm Sci.
2. Johnson R, Jiskoot W. 2012. Models for evaluation of relative immunogenic potential of protein particles in biopharmaceutical protein formulations. J Pharm Sci.
3. Ripple DC, Dimitrova MN. 2012. Protein particles: What we know and what we don't know. J Pharm Sci.
4. Bee JS, Goletz TJ, Ragheb JA. 2012. The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: A shared perspective. J Pharm Sci.