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In vitro- metoder for sammenligning av målbinding og CDC-induksjon mellom terapeutiske antistoffer: applikasjoner i biosimilaritetsanalyse
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1Unit for Development and Research in Bioprocesses Unit (UDIBI), National School of Biological Sciences,National Polytechnic Institute (IPN), University of Mexico (UNAM), 2School of Chemistry,National Autonomous University of Mexico (UNAM), 3Graduate Program in Chemical Sciences,National Autonomous University of Mexico (UNAM), 4Unit for Development Research and Medical Innovation in Biotechnology (UDIMEB), National School of Biological Sciences,National Polytechnic Institute (IPN), 5Department of Immunology, National Scool of Biological Sciences,National Polytechnic Institute (IPN), 6Department of Pharmacology and Unit of Translational Biomedicine (CMN 20 de noviembre), School of Medicine,National Autonomous University of Mexico (UNAM)
Chapitres
- 00:05Titre
- 00:48Flow Cytometric Target Binding Analysis
- 03:35Complement-dependent Cytotoxicity (CDC) Assessment
- 05:29Results: Representative Anti-CD20 Therapeutic Monoclonal Antibody Analyses
- 06:38Conclusion
Denne protokollen beskriver in vitro-sammenligning av to viktige funksjonelle egenskaper rituximab: målbindingsdomene og komplementavhengig cytotoksisitet (CDC) induksjon. Metodene som ble benyttet for en side-til-side-sammenligning mellom referanse rituximab rituximab og en biosimilar. Disse analyser kan anvendes under biosimilar utvikling eller som en kvalitetskontroll i sin produksjon.
