Clinical Immunogenicity Risk Assessment for a Fusion Protein-Reference-Cited by-同舟云学术

Clinical Immunogenicity Risk Assessment for a Fusion Protein

Published:2020-04-03 Issue:3 Volume:22 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Sperinde Gizette,Montgomery Diana,Mytych Daniel T.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-020-00447-y.pdf

Reference21 articles.

1. Chamberlain P. Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers. Bioanalysis. 2019.

2. FDA. Guidance for Industry, Immunogenicity Assessment for Therapeutic Protein Products. 2014.

3. Enbrel® (etanercept) Solution for Subcutaneous Use [Internet]. 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf.

4. Roopenian DC, Akilesh S. FcRn: the neonatal fc receptor comes of age. Nat Rev Immunol. 2007;7(9):715–25.

5. ORENCIA (abatacept) for injection, for intravenous use for subcutaneous use [Internet]. 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf.

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