The management of common and orphan diseases is challenging due to aberrant bleeding or coagulation. To achieve better disease control, modern therapeutics aim to improve precision and safety over traditional agents by leveraging highly selective and/or targeted modalities. While clotting and bleeding assays have been in use for many decades for analyzing blood products, standard

Anti-drug antibody (ADA) assessment is an integral part of biotherapeutic drug development, providing critical information about potential immunogenicity risks and their impact on drug safety and efficacy. To support development of complex biologic products, it is necessary to understand the unique considerations for use of ADA assays in early development, pre-clinical and clinical settings. Download