title: Preclinical development of monoclonal antibodies: considerations for the use of non-human primates.
abstract: The 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.
authors.affiliation: National Centre for Replacement, Refinement and Reduction of Animals in Research, London, UK. kathryn.chapman@nc3rs.org.uk
authors.forename: Kathryn
authors.initials: K
authors.lastname: Chapman
authors.forename: Nick
authors.initials: N
authors.lastname: Pullen
authors.forename: Lee
authors.initials: L
authors.lastname: Coney
authors.forename: Maggie
authors.initials: M
authors.lastname: Dempster
authors.forename: Laura
authors.initials: L
authors.lastname: Andrews
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Bajramovic
authors.forename: Paul
authors.initials: P
authors.lastname: Baldrick
authors.forename: Lorrene
authors.initials: L
authors.lastname: Buckley
authors.forename: Abby
authors.initials: A
authors.lastname: Jacobs
authors.forename: Geoff
authors.initials: G
authors.lastname: Hale
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.forename: Ian
authors.initials: I
authors.lastname: Ragan
authors.forename: Vicky
authors.initials: V
authors.lastname: Robinson
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D001709:Biotechnology / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004345:Drug Industry / Q000379:methods; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D008297:Male; D011323:Primates; D016730:Program Development; D013045:Species Specificity
chemical_list: D000911:Antibodies, Monoclonal