title: Animal-Friendly Affinity Reagents: Replacing the Needless in the Haystack.
abstract: The multibillion-dollar global antibody industry produces an indispensable resource but that is generated using millions of animals. Despite the irrefutable maturation and availability of animal-friendly affinity reagents (AFAs) employing naïve B lymphocyte or synthetic recombinant technologies expressed by phage display, animal immunisation is still authorised for antibody production. Remarkably, replacement opportunities have been overlooked, despite the enormous potential reduction in animal use. Directive 2010/63/EU requires that animals are not used where alternatives exist. To ensure its implementation, we have engaged in discussions with the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) and the Directorate General for Environment to carve out an EU-led replacement strategy. Measures must be imposed to avoid outsourcing, regulate commercial production, and ensure that antibody producers are fully supported.
authors.affiliation: AFABILITY, Morzine, France. Electronic address: draligray@afability.com.
authors.forename: A C
authors.initials: AC
authors.lastname: Gray
authors.affiliation: The Donnelly Centre, University of Toronto, Toronto, Canada.
authors.forename: S S
authors.initials: SS
authors.lastname: Sidhu
authors.affiliation: CM Scientia-Life Sciences Consulting, Ontario, Canada.
authors.forename: P C
authors.initials: PC
authors.lastname: Chandrasekera
authors.affiliation: Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.
authors.forename: C F M
authors.initials: CFM
authors.lastname: Hendriksen
authors.affiliation: Department of Immunotechnology, Lund University, Lund, Sweden.
authors.forename: C A K
authors.initials: CAK
authors.lastname: Borrebaeck
mesh_terms: D000826:Animal Testing Alternatives / Q000639:trends*; D000827:Animal Welfare / Q000639:trends*; D000818:Animals; D000906:Antibodies; D001709:Biotechnology / Q000639:trends*; D002478:Cells, Cultured; D005062:European Union; D011994:Recombinant Proteins
chemical_list: D000906:Antibodies; D011994:Recombinant Proteins
keywords: 3Rs; AFAs; Directive 2010/63/EU; alternatives to animals; animal welfare; animal-friendly affinity reagents; antibodies; monoclonal; polyclonal