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 ...

Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

insights from industryNatalie Strickland Global Head of Translational ScienceSynexa Life Sciences In this interview, News Medical speaks with Natalie Strickland, Global Head of Translational Science ...

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 ...

CRISPR-based assays can be adopted as ultrasensitive molecular diagnostics in resource-limited settings, but point-of-care applications must address additional requirements. Here, we discuss the major ...

Assessing the safety and efficacy of biotherapeutics is imperative during the drug development process. In particular, pharmacokinetic (PK) and anti-drug antibody (ADA) assays are conducted to study ...