Scientific and regulatory considerations on the immunogenicity of biologics
- 1 June 2006
- journal article
- review article
- Published by Elsevier in Trends in Biotechnology
- Vol. 24 (6) , 274-280
- https://doi.org/10.1016/j.tibtech.2006.04.001
Abstract
No abstract availableKeywords
This publication has 14 references indexed in Scilit:
- Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodiesJournal of Pharmaceutical and Biomedical Analysis, 2005
- Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology productsJournal of Immunological Methods, 2004
- Anti-Erythropoietin Antibodies and Pure Red Cell AplasiaJournal of the American Society of Nephrology, 2004
- The immunogenicity of biopharmaceuticalsNeurology, 2003
- Recombinant human thrombopoietin: basic biology and evaluation of clinical studiesBlood, 2002
- Bioequivalence and the immunogenicity of biopharmaceuticalsNature Reviews Drug Discovery, 2002
- Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant ErythropoietinNew England Journal of Medicine, 2002
- Antibodies to interferon (IFN) in hepatitis C patients relapsing while continuing recombinant IFN-α2 therapyClinical and Experimental Immunology, 1996
- Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys*1Fundamental and Applied Toxicology, 1991
- Development of antibodies to unprotected glycosylation sites on recombinant human GM-CSFThe Lancet, 1990