Anti-drug antibody (ADA) assays are critical to assess the clinical efficacy and safety of a biological drug and rely on control reagents that mimic the ADA response to the biological drug being tested. These positive controls typically consist of animal-derived pooled polyclonal antibodies or human monoclonal antibody reference panels against the target protein drug.
Monoclonal antibodies (mAbs) are homogenous antibodies that bind to a single epitope on an antigen. Kohler and Milstein generated the first mAbs when they developed hybridoma technology in the 1970s. Because of the specificity, homogeneity and unlimited availability, mAbs are valuable reagents used in a variety of important applications including treatment and diagnosis of diseases
The protein sequence is key to understanding the function of a protein target, and is critical to therapeutic and diagnostic development. This is particularly important for antibodies whose code diversity and glycosylation impact both function, and stability.
Anti-Drug Antibody (ADA) assays such as ligand-based assays are critical to assess the clinical efficacy and safety of a biological drug. ADA assays rely on control reagents that mimic the ADA response to the biological drug being tested. These positive controls typically consist of animal-derived (e.g., rabbits) pooled polyclonal antibodies (pAb) [...]
Antibodies are integral to life sciences research and therapeutic and diagnostics discovery and development. However, they are inherently prone to variability.
In vitro diagnostics (IVDs) are one of the most commonly used tools to diagnose conditions and guide treatment decisions, and are often considered the “silent champion” of healthcare. They work by detecting the absence or presence of particular markers or by measuring the concentration of analytes or specific substances.