Preclinical development of monoclonal antibodies: considerations for the use of non-human primates.
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.
Chapman
Kathryn
K
National Centre for Replacement, Refinement and Reduction of Animals in Research, London, UK. kathryn.chapman@nc3rs.org.uk
Pullen
Nick
N
Coney
Lee
L
Dempster
Maggie
M
Andrews
Laura
L
Bajramovic
Jeffrey
J
Baldrick
Paul
P
Buckley
Lorrene
L
Jacobs
Abby
A
Hale
Geoff
G
Green
Colin
C
Ragan
Ian
I
Robinson
Vicky
V
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
D000911:Antibodies, Monoclonal