Micro-flow imaging: Flow microscopy applied to sub-visible particulate analysis in protein formulations

AAPS Journal

Volumn 12, Issue 3, 2010, Pages 455-464

  Sharma, Deepak K ^a   King, Dave ^a   Oma, Peter ^a   Merchant, Clark ^a  

^a Brightwell Technologies Inc   (Canada)

Author keywords

light obscuration; micro flow imaging; particle sizing; protein aggregation; protein formulation

Indexed keywords

ARTICLE; CONTROLLED STUDY; FERMENTATION; FLOW RATE; MICRO FLOW IMAGING; MICROSCOPY; MORPHOLOGY; PARTICLE SIZE; PARTICULATE MATTER; PHARMACEUTICS; PROCESS OPTIMIZATION; PROCESS TECHNOLOGY; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN PURIFICATION; SENSITIVITY ANALYSIS; SHEAR FLOW; VISCOSITY; CHEMISTRY; LIMIT OF DETECTION; PROCEDURES; REFRACTOMETRY; REPRODUCIBILITY;

BIOLOGICAL PRODUCTS; LIMIT OF DETECTION; MICROSCOPY; PROTEINS; REFRACTOMETRY; REPRODUCIBILITY OF RESULTS; VISCOSITY;

BIOLOGICAL PRODUCT; PROTEIN;

EID: 77955933028     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-010-9205-1     Document Type: Article

References (19)

1. J Carpenter TW Randolph W Jiskoot D Crommelin C Middaugh G Winter Y Fan S Kirshner D Verthelyi S Kozlowski K Clouse P Swann A Rosenberg B Cherney 2008 Overlooking sub-visible particles in therapeutic protein products: gaps that may compromise product quality J Pharm Sci 98 4 1201 5 10.1002/jps.21530
2. Ives C, Soderquist R, Stoner M, Kendrick B. Light obscuration particulate analysis for protein solutions: challenges and limitations. Protein Stability Conference. 2007 Breckenridge (CO), USA.
3. D Sharma D King P Moore P Oma D Thomas 2007 Flow microscopy for particulate analysis in parenteral and pharmaceutical fluids Eur J Parent Pharm Sci. 12 4 97 101
4. D Sharma P Oma S Krishnan 2009 Silicone micro-droplets in protein formulations-detection and enumeration Pharma Tech 33 4 74 1:CAS:528: DC%2BD1MXlt1Gjurs%3D
5. C Huang D Sharma P Oma R Krishnamurthy 2009 Quantitation of protein particles in parenteral solutions using micro-flow imaging J Pharm Sci 98 9 3058 71 10.1002/jps.21575 1:CAS:528:DC%2BD1MXptl2isbg%3D 18937372
6. Huang C, Sharma D, Amplett G, Oma P, Krishnamurthy K. Quantitation of protein particles in parenteral solutions using light obscuration and micro-flow imaging. Protein Stability Conference. 2007 Breckenridge (CO), USA.
7. J Wen T Arakawa 2000 Refractive index of proteins in aqueous sodium chloride Anal Biochem 280 327 9 10.1006/abio.2000.4524 1:CAS:528: DC%2BD3cXivVWmu7Y%3D 10790320
8. V Ball JJ Ramsden 1998 Buffer dependence of refractive index increments of protein solutions Biopolym. 46 489 92 10.1002/(SICI)1097-0282(199812)46: 7<489::AID-BIP6>3.0.CO;2-E 1:CAS:528:DyaK1cXnsl2jsLc%3D
9. EY Chi S Krishnan TW Randolph JF Carpenter 2003 Physical stability of proteins in aqueous solution: mechanism and driving forces in non-native protein aggregation Pharm Res 20 9 1325 36 10.1023/A:1025771421906 1:CAS:528: DC%2BD3sXnt1KitLY%3D 14567625
10. EY Chi J Weickmann JF Carpenter MC Manning TW Randolph 2005 Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation J Pharm Sci 94 2 256 74 10.1002/jps.20237 1:CAS:528:DC%2BD2MXhtFOltro%3D 15570600
11. V Sluzky JA Tamada AM Klibanov R Langer 1991 Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces Proc Natl Acad Sci USA 88 21 9377 81 10.1073/pnas.88.21.9377 1:CAS:528:DyaK3MXmslSrtrg%3D 1946348
12. HC Mahler R Muller W Friess A Delille S Matheus 2005 Induction and analysis of aggregates in a liquid IgG1-antibody formulation Eur J Pharm Biopharm 59 3 407 17 10.1016/j.ejpb.2004.12.004 1:CAS:528:DC%2BD2MXit1Chsr8%3D 15760721
13. ImmunoGen. http://www.immunogen.com/wt/page/IMGN901b. Accessed 20 Jul 2008.
14. MJ Groves 1991 Particulate contamination in parenterals: current issues Boll Chim Farm 130 9 347 54 1:STN:280:DyaK387ovFOnuw%3D%3D 1799429
15. PA Ball K Bethune J Fox R Ledger M Barnett 2001 Particulate contamination in parenteral nutrition solutions: still a cause for concern? Nutrition 17 11-12 926 9 10.1016/S0899-9007(01)00708-0 1:CAS:528:DC%2BD3MXptVSksb0%3D 11744342
16. SJ Shire Z Shahrokh J Liu 2004 Challenges in the development of high protein concentration formulations J Pharm Sci 93 6 1390 402 10.1002/jps.20079 1:CAS:528:DC%2BD2cXks12iurY%3D 15124199
17. J Liu MDH Nquyen JD Andya SJ Shire 2005 Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution J Pharm Sci 94 1928 40 10.1002/jps.20347 1:CAS:528:DC%2BD2MXpslOgt7g%3D 16052543
18. D Sharma P Oma MJ Pollo M Sukumar 2009 Quantification and characterization of subvisible proteinaceous particles in opalescent mAb formulations using micro-flow imaging J Pharm Sci. 99 2628 42 10.1002/jps.22046
19. L Jones A Kaufmann C Middaugh 2005 Silicone oil induced aggregation of proteins J Pharm Sci 94 918 27 10.1002/jps.20321 1:CAS:528:DC%2BD2MXjtFCju7g%3D 15736189