Here, we review the current state of the art in analytical and structural methods used to
characterize therapeutic monoclonal antibodies (mAbs) and derivatives. First, a general …

Biologics such as monoclonal antibodies are much more complex than small-molecule
drugs, which raises challenging questions for the development and regulatory evaluation of …

Biofilm structure and functionality depend on extracellular polymeric substances (EPS), but
analytical methods for EPS often lack specificity which limits progress of biofilm research …

Regulatory agencies have recently recommended a Quality by Design (QbD) approach for
the manufacturing of therapeutic molecules. A QbD strategy requires deep understanding at …

Introduction: Proteins are effective biotherapeutics with applications in diverse ailments.
Despite being specific and potent, their full clinical potential has not yet been realized. This …

Highlights•Hydrogen/deuterium exchange mass spectrometry (HDX-MS) technology for
assessment of higher order structure of protein therapeutics.•Methodology: global HDX-MS …

Protein biopharmaceuticals such as monoclonal antibodies and therapeutic proteins are
currently in widespread use for the treatment of various life-threatening diseases including …

Monoclonal antibodies (mAbs) are powerful therapeutics, and their characterization has
drawn considerable attention and urgency. Unlike small-molecule drugs (150–600 Da) that …

Using mass spectrometry (MS) to obtain information about a higher order structure of protein
requires that a protein's structural properties are encoded into the mass of that protein …

Characterization of biopharmaceutical products is a challenging task, which needs to be
carried out at several different levels (including both primary structure and conformation). An …