Fluorescence resonance energy transfer (FRET)-based biosensors are effective analytical
tools extensively used in fields of biomedicine, pharmacology, toxicology, and food …

Monoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases.
Their high specificity to target antigens makes them ideal therapeutic agents for certain …

Aggregates of therapeutic proteins have been associated with increased immunogenicity in
pre-clinical models as well as in human patients. Recent studies to understand aggregates …

A survey conducted by the Therapeutic Product Immunogenicity (TPI) community within the
American Association of Pharmaceutical Scientists (AAPS) posed questions to the …

Therapeutic antibodies sometimes elicit anti-drug antibodies (ADAs) that can affect efficacy
and safety. Engineered antibodies that contain artificial amino acid sequences are …

Biotherapeutics, which are biologic medications that are natural or bioengineered products
of living cells, have revolutionized the treatment of many diseases. However, unwanted …

Biologics have the potential to induce an immune response when used therapeutically. A
number of in vitro assays are currently used preclinically to predict the risk of …

Product-and process-related critical quality attributes have the potential to impact
pharmacokinetics, immunogenicity, potency, and safety of biotherapeutics. Among these …

The pharmaceutical industry has experienced great successes with protein therapeutics in
the last two decades and with novel modalities, including cell therapies and gene therapies …

Background The efficacy and safety of therapeutic proteins are undermined by
immunogenicity driven by anti-drug antibodies. Immunogenicity risk assessment is critically …