title: Universal immunogenicity validation and assessment during early biotherapeutic development to support a green laboratory.
abstract: BACKGROUND
  Immunogenicity support during nonclinical biotherapeutic development can be resource intensive if supported by conventional methodologies. A universal indirect species-specific immunoassay can eliminate the need for biotherapeutic-specific anti-drug antibody immunoassays without compromising quality. By implementing the R's of sustainability (reduce, reuse, rethink), conservation of resources and greener laboratory practices were achieved in this study.
  
  
  RESULTS
  Statistical analysis across four biotherapeutics supported identification of consistent product performance standards (cut points, sensitivity and reference limits) and a streamlined universal anti-drug antibody immunoassay method implementation strategy.
  
  
  CONCLUSIONS
  We propose an efficient, fit-for-purpose, scientifically and statistically supported nonclinical immunogenicity assessment strategy. Utilization of a universal method and streamlined validation, while retaining comparability to conventional immunoassays and meeting the industry recommended standards, provides environmental credits in the scientific laboratory. Collectively, individual reductions in critical material consumption, energy usage, waste and non-environment friendly consumables, such as plastic and paper, support a greener laboratory environment.
authors.affiliation: Department of Clinical Immunology, Amgen Inc., One Amgen Center Drive, 30E-3-C, Thousand Oaks, CA 91320, USA.
authors.forename: Ami C
authors.initials: AC
authors.lastname: Bautista
authors.forename: Lei
authors.initials: L
authors.lastname: Zhou
authors.forename: Vibha
authors.initials: V
authors.lastname: Jawa
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000097:blood*; D000918:Antibody Specificity; D019084:Fluorescent Antibody Technique, Indirect / Q000592:standards*; D055772:Green Chemistry Technology / Q000295:instrumentation / Q000592:standards*; D006801:Humans; D018796:Immunoconjugates / Q000737:chemistry; D007074:Immunoglobulin G / Q000097:blood*; D008163:Luminescent Measurements / Q000295:instrumentation / Q000592:standards*; D008252:Macaca fascicularis / Q000097:blood / Q000276:immunology; D051379:Mice; D011817:Rabbits; D015203:Reproducibility of Results; D012428:Ruthenium / Q000737:chemistry; D012680:Sensitivity and Specificity; D013045:Species Specificity; D054928:Validation Studies as Topic
chemical_list: D000911:Antibodies, Monoclonal; D018796:Immunoconjugates; D007074:Immunoglobulin G; D012428:Ruthenium