Prevention of stirring-induced microparticle formation in monoclonal antibody solutions

Biological and Pharmaceutical Bulletin

Volumn 33, Issue 6, 2010, Pages 1043-1046

  Ishikawa, Tomoyoshi ^a,b   Kobayashi, Noritaka ^a   Osawa, Chie ^a   Sawa, Eiji ^a   Wakamatsu, Kaori ^b  

^a KYOWA HAKKO KOGYO CO LTD   (Japan)

^b GUNMA UNIVERSITY   (Japan)

Author keywords

Aggregation; Microparticle; Monoclonal antibody; Shear stress; Stirring

Indexed keywords

IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY; PROTEIN;

ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; DRUG MANUFACTURE; FILTER; FILTRATION; GEL PERMEATION CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INFRARED SPECTROSCOPY; LIGHT SCATTERING; MEMBRANE TRANSPORT; SHEAR STRESS;

ANTIBODIES, MONOCLONAL; CHEMISTRY, PHARMACEUTICAL; FILTRATION; HUMANS; PARTICLE SIZE; PHARMACEUTICAL SOLUTIONS; STRESS, MECHANICAL;

EID: 77953449836     PISSN: 09186158     EISSN: 13475215     Source Type: Journal    
DOI: 10.1248/bpb.33.1043     Document Type: Article

References (16)

1. Hudson P. J., Souriau C., Nat. Med., 9, 129-134 (2003).
2. Carter P., Nat. Rev. Cancer, 1, 118-129 (2001).
3. Daugherty A. L., Mrsny R. J., Adv. Drug Deliv. Rev., 58, 686-706 (2006).
4. Cromwell M. E. M., Hilario E., Jacobson F., AAPS J., 8, E572-E579 (2006).
5. Carpenter J. F., Randolph T. W., Jiskoot W., Crommelin D. J., Mid- daugh C. R., Winter G., Fan Y. X., Kirshner S., Verthelyi D., Ko-zlowski S., Clouse K. A., Swann P. G., Rosenberg A., Cherney B., J. Pharm. Sci., 98, 1201-1205 (2009).
6. Hermeling S., Schellekens H., Maas C., Gebbink M. F., Crommelin D. J., Jiskoot W., J. Pharm. Sci., 95, 1084-1096 (2006).
7. Kanai S., Liu J., Patapoff T. W., Shire S. J., J. Pharm. Sci., 97, 4219-4227 (2008).
8. Chi E. Y., Krishnan S., Randolph T. W., Carpenter J. F., Pharm. Res., 20, 1325-1336 (2003).
9. Brennan J. R., Gebhart S. S., Blackard W. G., Diabetes, 34, 353-359 (1985).
10. Vermeer A. W., Giacomelli C. E., Norde W., Biochim. Biophys. Acta, 1526, 61-69 (2001).
11. Bee J. S., Stevenson J. L., Mehta B., Svitel J., Pollastrini J., Platz R., Freund E., Carpenter J. F., Randolph T. W., Biotechnol. Bioeng., 103, 936-943 (2009).
12. Chang B. S., Kendrick B. S., Carpenter J. F., J. Pharm. Sci., 85, 1325-1330 (1996).
13. Tyagi A. K., Randolph T. W., Dong A., Maloney K. M., Hitscherich C. Jr., Carpenter J. F., J. Pharm. Sci., 98, 94-104 (2009).
14. Badmington F., Wilkins R., Payne M., Honig E., Biopharmacology, 1995, 46-52 (1995).
15. Ala P. J., Huston E. E., Klabe R. M., McCabe D. D., Duke J. L., Rizzo C. J., Korant B. D., DeLoskey R. J., Lam P. Y. S., Hodge C. N., Chang C.-H., Biochemistry, 36, 1573-1580 (1997).
16. Wan Y., Vasan S., Ghosh R., Hale G., Cui Z., Biotechnol. Bioeng., 90, 422-432 (2005).