Silicone-oil-based subvisible particles: Their detection, interactions, and regulation in prefilled container closure systems for biopharmaceuticals

Journal of Pharmaceutical Sciences

Volumn 101, Issue 12, 2012, Pages 4569-4583

  Felsovalyi, Flora ^a   Janvier, Sébastien ^b   Jouffray, Sébastien ^b   Soukiassian, Hervé ^b   Mangiagalli, Paolo ^b  

^a BD Technologies   (United States)

^b BD Medical Pharmaceutical Systems   (France)

Author keywords

Biotechnology; Drug delivery systems; Drug interactions; Excipients; Injectables; Parental solutions; Prefillable systems; Prefilled syringes; Silicone oil; Subvisible particles

Indexed keywords

EID: 84868201063     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23328     Document Type: Article

References (35)

1. Pavlou AK, Belsey MJ. 2005. The therapeutic antibodies market to 2008. Eur J Pharm Biopharm 59(3):389-396.
2. Chaubal MV, Roseman TJ. 2006. Drug delivery trends for parenteral therapeutics. Drug Deliv Syst 21(4):388-397.
3. United States Pharmacopeia and National Formulary (USP29-NF24). 2007. <788> Particulate matter in injections. 28(6):1930.
4. European Pharmacopoeia. 2010. 2.9.19 Particluate Contamination: Sub-visible particles. 7th ed, Supplement 7.2: 3333-3335.
5. The Japanese Pharmacopoeia. 2006. Insoluble particulate matter test for injections. 15th ed. 6.07:111-113.
6. Oma P, Sharma DK, King D. 2010. Flow microscopy: Dynamic image analysis for particle counting. Pharmacopeial Forum 36(1):311-320.
7. Cherney B. 2011. Current regulatory considerations for the assessment of sub-visible particles. WCBP CMC strategy forum, Washington, DC, 9 January.
8. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause HJ, Mahler HC, Meyer BK, Narhi L, Nesta DP, Spitznagel T. 2010. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 99(8):3302-3321.
9. Nath N, McNeal E, Obenhuber D, Pillari B, Shelton L, Stevens-Riley M, Sweeney N. 2004. Particulate contaminants of intraveneous medication and the limits set by USP General Chapter <788> Pharmacopeial Forum 03:0822-2722.
10. Narhi LO, Schmit J, Bechtold-Peters K, Sharma D. 2011. Classification of protein aggregates. J Pharm Sci 101(2):493-498.
11. Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. 2009. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 10(4):373-381.
12. Philo JS. 2006. Is any measurement method optimal for all aggregate sizes and types? AAPS J 8(3):E564-E571.
13. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98(4):1201-1205.
14. Singh S. 2010. Large molecule products: Criteria for particulate matter in biologics. USP workshop on particle size: Particle detection & measurement. Rockville, Maryland, 9 December.
15. Romacker M, Shoenknecht T, Forster R. 2008. The rise of prefilled syringes from niche product to primary container of choice: A short history. On Drug Deliv 14:4-5.
16. Asakura T, Seino H, Nakano R, Muto T, Toraishi K, Sako Y, Kageyama M, Yohkoh N. 2009. A comparison of the handling and accuracy of syringe and vial versus prefilled insulin pen (FlexPen). Diabetes Technol Ther 11(10):657-661.
17. Hofer G. 2009. The advantages and challenges of developing a drug product in prefilled syringes. On Drug Deliv 15:16-18.
18. Pereira CC, Bishai D. 2010. Vaccine presentation in the USA: Economics of prefilled syringes versus multidose vials for influenza vaccination. Expert Rev Vaccines 9(11):1343-1349.
19. Majumdar S, Ford BM, Mar KD, Sullivan VJ, Ulrich RG, DSouza AJ. 2011. Evaluation of the effect of syringe surfaces on protein formulations. J Pharm Sci 100(7):2563-2573.
20. United States Pharmacopeia and National Formulary (USP29-NF24). Dimethicone. 29(1):142.
21. Zolls S, Tantipolphan R, Wiggenhorn M, Winter G, Jiskoot W, Friess W, Hawe A. 2012. Particles in therapeutic protein formulations, Part 1: Overview of analytical methods. J Pharm Sci 101(3):914-935.
22. Huang CT, Sharma D, Oma P, Krishnamurthy R. 2009. Quantitation of protein particles in parenteral solutions using micro-flow imaging. J Pharm Sci 98(9):3058-3071.
23. Ripple D. 2010. NIST perspective on standards for subvisible particles (with an emphasis on protein therapeutics). USP workshop on particle size: Particle detection & measurement, Rockville, Maryland, 8 December.
24. Sharma DK KD, Oma P, Merchant C. 2010. Micro-flow imaging: Flow microscopy applied to sub-visible particulate analysis in protein formulations. AAPS J 12(3):455-464.
25. Merchant C, Sharma DK, King D, Oma P. 2010. Differentiation of protein aggregates, silicone oil droplets and air bubbles in formulations using Micro-flow imaging. IBC's 5th Annual Biophysical Analysis of Bioprocessing Conference, San Francisco, California, 12 May.
26. Sharma D, Oma P, Krishnan S. 2009. Silicone microdroplets in protein formulations-Detection and enumeration. PharmTech 33(4):74-79.
27. Sharma DK, Oma P, Pollo MJ, Sukumar M. 2010. Quantification and characterization of subvisible proteinaceous particles in opalescent mab formulations using micro-flow imaging. J Pharm Sci 99(6):2628-2642.
28. Demeule B, Messick S, Shire SJ, Liu J. 2010. Characterization of particles in protein solutions: Reaching the limits of current technologies. AAPS J 12(4):708-715.
29. Jones LS, Kaufmann A, Middaugh CR. 2005. Silicone oil induced aggregation of proteins. J Pharm Sci 94(4):918-927.
30. Ludwig DB, Carpenter JF, Hamel J-B, Randolph TW. 2010. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci 99(4):1721-1733.
31. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. 2009. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci 98(9):3167-3181.
32. Ludwig DB, Trotter JT, Gabrielson JP, Carpenter JF, Randolph TW. 2011. Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations. Anal Biochem 410:191-199.
33. Bartzoka V, McDermott MR, Brook MA. 1999. Protein-silicone interactions. Adv Mater 11(3):257-259.
34. Lankers M. 2010. The relationship between silicone layer thickness, free silicone oil and protein aggregation in prefilled syringes. AAPS2010 NationalAPPS Biotechnologynational Conference, biotechnology San Francisco, California, 18 May.
35. Mundry T. 1999. Einbrennsilikonisierung bei pharmazeutischen Glaspackmitteln-Analytische studien eines produktionsprozesses. Ph.D. Thesis. Berlin: Germany: Humboldt University.