Author/Authors :
Ponce، نويسنده , , Rafael and Abad، نويسنده , , Leslie and Amaravadi، نويسنده , , Lakshmi and Gelzleichter، نويسنده , , Thomas and Gore، نويسنده , , Elizabeth and Green، نويسنده , , James and Gupta، نويسنده , , Shalini and Herzyk، نويسنده , , Danuta and Hurst، نويسنده , , Christopher and Ivens، نويسنده , , Inge A. and Kawabata، نويسنده , , Thomas and Maier، نويسنده , , Curtis and Mounho، نويسنده , , Barbara and Rup، نويسنده , , Bonita and Shankar، نويسنده , , Gopi and Smith، نويسنده , , Holly P. Thomas، نويسنده , , Peter and Wierda، نويسنده , , Dan، نويسنده ,
Abstract :
An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.
