Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2009 Apr;98(4):1201-5.
doi: 10.1002/jps.21530.

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality

John F Carpenter  1 , Theodore W Randolph, Wim Jiskoot, Daan J A Crommelin, C Russell Middaugh, Gerhard Winter, Ying-Xin Fan, Susan Kirshner, Daniela Verthelyi, Steven Kozlowski, Kathleen A Clouse, Patrick G Swann, Amy Rosenberg, Barry Cherney
Affiliations

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality

John F Carpenter et al. J Pharm Sci. 2009 Apr.
No abstract available

PubMed Disclaimer

References

    1. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dialysis Transplant. 2006;21(Suppl 5):9–12. - PubMed
    1. Rosenberg AS. Effects of Protein Aggregates: An Immunologic Perspective. AAPS J. 2006;8:E501–E507. - PMC - PubMed
    1. Hooks WK. Urgent inhibitor issues: targets for expanded research. Haemophilia. 2006;12 (Suppl 6):107–113. - PubMed
    1. Reipert BM, van den Helden PM, Schwartz H-P, Hausl C. Mechanisms of action of immune tolerance induction against factor VIII in patients with cogenital haemophilia A and factor VIII inhibitors. British J Haemophilia. 2007;136:12–25. - PubMed
    1. Chi EY, Krishnan S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation. Pharm Res. 2003;20:1325–1336. - PubMed

MeSH terms

Substances