Managing the Impact of Immunogenicity in an Era of Immunotherapy: From Bench to Bedside

Biotherapeutics have revolutionized our ability to treat life-threatening diseases. Despite clinical success, the use of biotherapeutics has sometimes been limited by immune response mounted against them in form anti-drug antibodies (ADAs). The multifactorial nature immunogenicity prevented a standardized approach for assessing this and each assessment methods developed so far does not exhibit high enough reliability be used alone, due predictiveness. This prompted Roche Pharma Research Early Development (pRED) Immunogenicity Working Group establish an internal preclinical toolbox vitro/in vivo approaches accompanying guidelines harmonized management early development. In article, complex factors influencing their associated ramifications are discussed highlight importance end-to-end conducted from lead optimization candidate selection. We then examine impact resulting categorization on design implementation multi-tiered ADA/immunogenicity assay strategy prior phase I (entry into human) through Ultimately, Toolbox ensures that pRED teams equipped address manner, paving way lifesaving products with improved safety efficacy.