Radiolabelling small molecules with beta-emitters has been intensively explored in the last
decades and novel concepts for the introduction of radionuclides continue to be reported …

Over the years, multiple biomarkers have been used to aid in disease screening, diagnosis,
prognosis, and response to therapy. As of late, protein biomarkers are gaining strength in …

Antibody–drug conjugates (ADCs) pose challenges to bioanalysis because of their
inherently intricate structures and potential for very complex catabolism. Common …

Recent advancements in immunocapture methods and mass spectrometer technology have
enabled intact protein mass spectrometry to be applied for the characterization of antibodies …

Degradation analysis of therapeutic mAb is of high interest for critical quality attributes
assessment and biotransformation studies. However, some obstacles, including low in vivo …

Antibody-drug conjugates (ADCs) are a class of biopharmaceuticals that combine the
specificity of monoclonal antibodies (mAbs) with the cytotoxicity of small molecule drugs. 15 …

In the absence of regulatory guidelines for the bioanalysis of new drug modalities, many of
which contain multiple functional domains, bioanalytical strategies have been carefully …

Labelling of therapeutic antibodies with radionuclides or fluorophores is routinely used to
study their pharmacokinetic properties. A critical assumption in utilizing labelled therapeutic …

Unlike with new chemical entities, the biotransformation of therapeutic proteins (TPs) has not
been routinely investigated or included in regulatory filings. Nevertheless, there is an …

Detailed assessment of the fate of drugs in nonclinical test species and humans is essential
to ensure the safety and efficacy of medicines in patients. In this context, biotransformation of …