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Quality of original and biosimilar epoetin products.
Brinks V, Hawe A, Basmeleh AH, Joachin-Rodriguez L, Haselberg R, Somsen GW, Jiskoot W, Schellekens H. Brinks V, et al. Pharm Res. 2011 Feb;28(2):386-93. doi: 10.1007/s11095-010-0288-2. Epub 2010 Oct 1. Pharm Res. 2011. PMID: 20886265 Free PMC article.
METHODS: Two original products, Eprex (epoetin alpha) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alpha) and Retacrit (epoetin zeta), were compared using (1) high performance size exclusion chromatography, (2) ELISA, (3) SDS-PAGE, (4) capilla …
METHODS: Two original products, Eprex (epoetin alpha) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alpha) and …
Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice.
Filipe V, Jiskoot W, Basmeleh AH, Halim A, Schellekens H, Brinks V. Filipe V, et al. MAbs. 2012 Nov-Dec;4(6):740-52. doi: 10.4161/mabs.22066. Epub 2012 Sep 5. MAbs. 2012. PMID: 22951518 Free PMC article.
These formulations were injected in mice transgenic (TG) for human genes for Ig heavy and light chains and their non-transgenic (NTG) counterparts. Anti-drug antibody (ADA) titers were determined by bridging ELISA. Both unstressed IgG and freeze-thawed formulation did not …
These formulations were injected in mice transgenic (TG) for human genes for Ig heavy and light chains and their non-transgenic (NTG) counte …
Effect of treatment regimen on the immunogenicity of human interferon Beta in immune tolerant mice.
Kijanka G, Jiskoot W, Schellekens H, Brinks V. Kijanka G, et al. Pharm Res. 2013 Jun;30(6):1553-60. doi: 10.1007/s11095-013-0992-9. Epub 2013 Jan 30. Pharm Res. 2013. PMID: 23361590
METHODS: Immune tolerant transgenic mice received injections with Betaferon via different routes, doses and injection frequencies. Anti-drug antibody (ADA) production was measured by ELISA to assess immunogenicity. RESULTS: A single injection of Betaferon was found to be s …
METHODS: Immune tolerant transgenic mice received injections with Betaferon via different routes, doses and injection frequencies. Anti-drug …
Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance by human interferon beta.
van Beers MM, Sauerborn M, Gilli F, Hermeling S, Brinks V, Schellekens H, Jiskoot W. van Beers MM, et al. J Immunol Methods. 2010 Jan 31;352(1-2):32-7. doi: 10.1016/j.jim.2009.10.005. Epub 2009 Oct 24. J Immunol Methods. 2010. PMID: 19857496
In this study, we used the original C57Bl/6 mouse model as well as the hybrid offspring from crossings of transgenic C57Bl/6 mice with wildtype FVB/N mice to study the immunogenicity of three commercial rhIFNbeta products, Rebif, Avonex and Betaferon. As determined by ELISA …
In this study, we used the original C57Bl/6 mouse model as well as the hybrid offspring from crossings of transgenic C57Bl/6 mice with wildt …