Since the mid-1980s, therapeutic monoclonal antibodies have become the fastest-growing class of therapeutics. This was due to the numerous pharmaceutical companies that were trying to find more drug ...

First in human (FIH) clinical trials of bispecific immunostimulatory antibodies commonly require a low starting dose based on a minimum anticipated biological effect level (MABEL) approach. To ...

Drug safety and efficacy are key concerns for manufacturers during the long, complex, and costly drug development process. Regulatory agencies now expect that immune responses caused by drug treatment ...

Assessing the pharmacokinetics (PK) of antibody-drug conjugates (ADCs) in both preclinical and clinical settings is crucial for their development. Biotransformation processes can lead to the creation ...

As scientists continue to expand the utility of biomarkers in basic and applied life science research, advances in immunoassay technologies further empower these efforts by improving the way key ...

Having a robust immunogenicity assay for accurate evaluation of ADA in animal models is important for enabling effective decision-making during development. Learn how a robust anti-drug antibody assay ...