Characterization of particles in protein solutions: Reaching the limits of current technologies

AAPS Journal

Volumn 12, Issue 4, 2010, Pages 708-715

  Demeule, Barthélemy ^a   Messick, Steven ^a   Shire, Steven J ^a   Liu, Jun ^a  

^a GENENTECH INC   (United States)

Author keywords

Biopharmaceuticals; Protein; Sub visible particles

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY MAB1; SILICONE OIL; UNCLASSIFIED DRUG;

ACCURACY; ANALYTIC METHOD; ANIMAL CELL; ARTICLE; CONTROLLED STUDY; COULTER COUNTER; DRUG DETERMINATION; DRUG FORMULATION; FLOW MICROSCOPY; LIGHT OBSCURATION; NONHUMAN; PARTICLE SIZE;

PARTICLE SIZE; PROTEINS; SILICONE OILS; SOLUTIONS; VISCOSITY;

EID: 78649661342     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-010-9233-x     Document Type: Article

References (24)

1. JF Carpenter TW Randolph W Jiskoot DJ Crommelin CR Middaugh G Winter, et al. 2009 Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality J Pharm Sci 98 4 1201 5 1:CAS:528: DC%2BD1MXktlSisLs%3D 10.1002/jps.21530 18704929
2. AS Rosenberg 2006 Effects of protein aggregates: an immunologic perspective AAPS J 8 3 E501 7 10.1208/aapsj080359 17025268 (Pubitemid 44294011)
3. A Braun L Kwee MA Labow J Alsenz 1997 Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice Pharm Res 14 10 1472 8 1:CAS:528:DyaK2sXntFehtL0%3D 10.1023/A:1012193326789 9358564 (Pubitemid 27481082)
4. H Schellekens 2007 Lesson learned from Eprex-associated pure red cell aplasia Kidney Blood Press Res 30 Suppl 1 9 12 10.1159/000107095 17726337 (Pubitemid 47313034)
5. SK Singh N Afonina M Awwad K Bechtold-Peters JT Blue D Chou, 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 21 1:CAS:528: DC%2BC3cXnvFGkt7g%3D 10.1002/jps.22097 20310025
6. LO Narhi Y Jiang S Cao K Benedek D Shnek 2009 A critical review of analytical methods for subvisible and visible particles Curr Pharm Biotechnol 10 4 373 81 1:CAS:528:DC%2BD1MXotlCnt7k%3D 10.2174/138920109788488905 19519412
7. HC Mahler W Friess U Grauschopf S Kiese 2009 Protein aggregation: pathways, induction factors and analysis J Pharm Sci 98 9 2909 34 1:CAS:528:DC%2BD1MXptl2isb0%3D 10.1002/jps.21566 18823031
8. S Kiese A Pappenberger W Friess HC Mahler 2010 Equilibrium studies of protein aggregates and homogeneous nucleation in protein formulation J Pharm Sci 99 2 632 44 1:CAS:528:DC%2BD1MXhsF2jsL3E 19548315
9. AK Tyagi TW Randolph A Dong KM Maloney C Hitscherich Jr JF Carpenter 2009 IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles J Pharm Sci 98 1 94 104 1:CAS:528:DC%2BD1MXns1SqsQ%3D%3D 10.1002/jps.21419 18454482
10. DK Sharma P Oma MJ Pollo M Sukumar 2010 Quantification and characterization of subvisible proteinaceous particles in opalescent mAb formulations using micro-flow imaging J Pharm Sci 99 6 2628 42 1:CAS:528:DC%2BC3cXkvVOktbs%3D 20049937
11. K Wuchner J Buchler R Spycher P Dalmonte DB Volkin 2010 Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation J Pharm Sci 99 8 3343 61 1:CAS:528:DC%2BC3cXnvFGrsrc%3D 10.1002/jps.22123 20229596
12. DK Sharma D King P Oma C Merchant 2010 Micro-flow imaging: flow microscopy applied to sub-visible particulate analysis in protein formulations AAPS J 12 3 455 64 1:CAS:528:DC%2BC3cXovVKnsLw%3D 10.1208/s12248-010-9205-1 20517661
13. V Filipe A Hawe W Jiskoot 2010 Critical evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates Pharm Res 27 5 796 810 1:CAS:528:DC%2BC3cXisl2jtbw%3D 10.1007/s11095-010-0073-2 20204471
14. SJ Shire Z Shahrokh J Liu 2004 Challenges in the development of high protein concentration formulations J Pharm Sci 93 6 1390 402 1:CAS:528:DC%2BD2cXks12iurY%3D 10.1002/jps.20079 15124199 (Pubitemid 38725014)
15. RJ Harris SJ Shire C Winter 2004 Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies Drug Dev Res 61 3 137 54 1:CAS:528:DC%2BD2cXms1Gmtr0%3D 10.1002/ddr.10344 (Pubitemid 39043719)
16. S Cao Y Jiang L Narhi 2010 A light-obscuration method specific for quantifying subvisible particles in protein therapeutics Pharmacop Forum 36 3 824 34
17. S Cao N Jiao Y Jiang A Mire-Sluis LO Narhi 2009 Sub-visible particle quantitation in protein therapeutics Pharmeur Bio Sci Notes 2009 1 73 9 1:STN:280:DC%2BC3c7gt1egsw%3D%3D 20144454
18. S Kanai J Liu TW Patapoff SJ Shire 2008 Reversible self-association of a concentrated monoclonal antibody solution mediated by Fab-Fab interaction that impacts solution viscosity J Pharm Sci 97 10 4219 27 1:CAS:528: DC%2BD1cXht1Sgt7rE 10.1002/jps.21322 18240303
19. CT 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 1:CAS:528:DC%2BD1MXptl2isbg%3D 10.1002/jps.21575 18937372
20. HC Mahler F Senner K Maeder R Mueller 2009 Surface activity of a monoclonal antibody J Pharm Sci 98 12 4525 33 1:CAS:528:DC%2BD1MXhtlCjsL%2FL 10.1002/jps.21776 19655376
21. F Pavanetto B Conti I Genta T Modena 1991 Particulate contamination from siliconized rubber stoppers Int J Pharm 74 175 81 1:CAS:528:DyaK3MXlvV2ksLs%3D 10.1016/0378-5173(91)90234-F
22. RR Henriquez T Ito L Sun RM Crooks 2004 The resurgence of Coulter counting for analyzing nanoscale objects Analyst 129 6 478 82 1:CAS:528:DC%2BD2cXktVOqsr4%3D 10.1039/b404251b 15222315 (Pubitemid 38813510)
23. T Sendo K Otsubo A Hisazumi T Aoyama R Oishi 1995 Particle contamination in contrast media induced by disposable syringes J Pharm Sci 84 12 1490 1 1:CAS:528:DyaK2MXptFGisLs%3D 10.1002/jps.2600841218 8748334
24. MJ Groves D Wana 1977 A comparison of instrumental techniques for the determination of contamination in filtered aqueous solutions Powder Technol 18 215 23 1:CAS:528:DyaE1cXmsFyrtQ%3D%3D 10.1016/0032-5910(77)80011-9