Preclinical development of monoclonal antibodies
2009; Landes Bioscience; Volume: 1; Issue: 5 Linguagem: Inglês
10.4161/mabs.1.5.9676
ISSN1942-0870
AutoresKathryn Chapman, Nick Pullen, Lee Coney, Maggie Dempster, Laura Andrews, Jeffrey J. Bajramović, Paul Baldrick, Lorrene A. Buckley, Abby Jacobs, G Hale, Colin Green, Ian Ragan, Vicky Robinson,
Tópico(s)Biosimilars and Bioanalytical Methods
ResumoThe development of mAbs remains high on the therapeutic agenda for the majority of pharmaceutical and biotechnology companies. Often, the only relevant species for preclinical safety assessment of mAbs are non-human primates (NHPs), and this raises important scientific, ethical and economic issues. To investigate evidence-based opportunities to minimize the use of NHPs, an expert working group with representatives from leading pharmaceutical and biotechnology companies, contract research organizations and institutes from Europe and the USA, has shared and analyzed data on mAbs for a range of therapeutic areas. This information has been applied to hypothetical examples to recommend scientifically appropriate development pathways and study designs for a variety of potential mAbs. The addendum of ICHS6 provides a timely opportunity for the scientific and regulatory community to embrace strategies which minimize primate use and increase efficiency of mAb development.
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