Article
Post hoc assessment of the immunogenicity of bioengineered factor VIIa demonstrates the use of preclinical tools.
Science translational medicine - 11 Jan 2017
Lamberth Kasper, Reedtz-Runge Stine Louise, Simon Jonathan, Klementyeva Ksenia, Pandey Gouri Shankar, Padkjær Søren Berg, Pascal Véronique, León Ileana R, Gudme Charlotte Nini, Buus Søren, Sauna Zuben E
Abstract excerpt
Immunogenicity is an important consideration in the licensure of a therapeutic protein because the development of neutralizing anti-drug antibodies (ADAs) can affect both safety and efficacy. Neoantigens introduced by bioengineering of a protein drug are a particular cause for concern. The development of a bioengineered recombinant factor VIIa (rFVIIa) analog was discontinued after phase 3 trials because of the...
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