A light-obscuration method specific for quantifying subvisible particles in protein therapeutics

Pharmacopeial Forum

Volumn 36, Issue 3, 2010, Pages

  Cao, Shawn ^a   Jiang, Yijia ^a   Narhi, Linda ^a   Hunt, Desmond ^b  

^a AMGEN INC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G2; POLYSTYRENE;

ACCURACY; ARTICLE; CONTROLLED STUDY; DRUG SPECIFICITY; PARTICLE SIZE; PARTICULATE MATTER; PHARMACOLOGICAL PROCEDURES; PROTEIN ANALYSIS; SMALL VOLUME LIGHT OBSCURATION;

EID: 78649673766     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. USP. USP 32-NF 27, Particulate Matter in Injections < 788 >. Rockville, MD: USP; 2009:310-312.
2. Council of Europe. Particulate Contamination: Subvisible Particles 2.9.19. Strasbourg, France: Council of Europe; 2007.
3. Clausi A, Cummiskey J, Merkley S, Carpenter JF, Braun LJ, Randolph TW. Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine. J Pharm Sci. 2008;97(12):5252-5262.
4. Cao S, Narhi L, Jiang J, Rajan R. Analysis of subvisible particulates. In: Mahler HC, Jiskoot W, eds. Analysis of Aggregates and Particles in Protein Pharmaceuticals. New York: John Wiley and Sons; 2010.
5. Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol. 2009;10(4):373-381.
6. Driscoll DF. Examination of selection of light-scattering and light-obscuration acceptance criteria for lipid injectable emulsions. Pharm Forum. 2004;30:2244-2253. (Pubitemid 44252024)
7. Cao S, Jiao N, Jiang Y, Mire-Sluis A, Narhi LP. Subvisible particle quantitation in protein therapeutics. Pharmeuropa Bio & Sci Notes. 2009;1:73-79.