Monitoring of subvisible particles in therapeutic proteins

Methods in Molecular Biology

Volumn 899, Issue , 2012, Pages 379-401

  Singh, Satish K ^a   Toler, Maria R ^a  

^a PFIZER INC   (United States)

Author keywords

Coulter counter; Dynamic imaging; Electrozone sensing; Flow imaging; HIAC; Injectables; Light obscuration; Membrane microscopy; Micro Flow imaging; NanoSight; Optical microscopy; Parenterals; Single particle tracking; Subvisible particulates

Indexed keywords

PROTEIN;

ARTICLE; CHEMISTRY; DRUG CONTAMINATION; FLOW CYTOMETRY; HUMAN; ISOLATION AND PURIFICATION; METHODOLOGY; MICROSCOPY; PARTICLE SIZE;

DRUG CONTAMINATION; FLOW CYTOMETRY; HUMANS; MICROSCOPY; PARTICLE SIZE; PROTEINS;

EID: 84864115266     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-61779-921-1_24     Document Type: Article

References (8)

1. Carpenter JF, Randolph TW, Jiskoot W et al (2009) Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98(4): 1202-1205
2. Singh SK, Afonina A, Awwad M et al (2010) An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 99(8): 3302-3321
3. Narhi LO, Jiang Y, Cao S et al (2009) A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 10(4): 373-381
4. US Pharmacopeia (2011) USP/NF General Chapter . Particulate matter in injections. In: US Pharmacopeia, National Formulary, USP34/NF-29 (suppl. 1). Rockville, MD
5. European Pharmacopoeia (2011) 7th edn. (7.2). General Chapter 2.9.19. Particulate contamination: Sub-visible particles. European Pharma copoeia Commission, Council of Europe, European Department for the Quality of Medicines
6. Japanese Pharmacopoeia (2011) 16th edn. General Chapter 20. Foreign insoluble particulate matter test for injections. Society of Japanese Pharmacopoeia
7. Sharma DK, King D, Moore P et al (2007) Flow microscopy for particulate analysis in parenteral and pharmaceutical fl uids. Eur J Parenter Pharm Sci 12(4):97-101
8. Filipe V, Hawe A, Jiskoot W (2010) Critical evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates. Pharm Res 27(5):796-810