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
Understanding Anti-Drug Antibody Assessment: Early Discovery through Clinical Trials Read More »
Anti-drug antibodies (ADAs) can hinder development of complex therapeutic modalities, like bispecific molecules and gene therapies. It is critical to understand the potential for ADA formation by the host of these therapeutic drug products as well as the impact of ADA on critical in vivo parameters such as PK and drug clearance rate. Having a robust
Anti-drug Antibody (ADA) Assays for Complex Molecule Development Read More »
The 2018 Vanderlaan et al. publication remains one of the most insightful summaries of biopharma’s experience with host cell proteins (HCPs). It includes a case study on MCP-1—an HCP linked to adverse events—that underscores why accurate detection, monitoring, and clearance during process development are critical to product safety. Essential reading for scientists, process developers, and anyone working
HCP Spotlight: Understanding MCP-1 in Biologics Read More »
