Bonita Rup

TL;DR: This document provides recommendations for antibody testing strategies stemming from the experience of contributing authors to foster a more unified approach to antibody testing across the biopharmaceutical industry.

TL;DR: 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 are described.

TL;DR: This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies.

TL;DR: Recommendations on best practices for the validation of cell-based NAb assay and suggested validation parameters based on the experience of the authors are provided.

TL;DR: A potential coupling between aggregation and immunogenicity is described: T-cell and B-cell immune epitopes in therapeutic proteins may contain aggregation-prone regions and opens up an exciting potential for rational design of de-immunized novel, as well as follow on biotherapeutics with reduced aggregation propensity.