Protein-based therapeutics have led to new paradigms in disease treatment. Projected to be
half of the top ten selling drugs in 2023, proteins have emerged as rivaling and, in some …

The investigation of macromolecular biomolecules with ion mobility mass spectrometry (IM-
MS) techniques has provided substantial insights into the field of structural biology over the …

Abstract Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) spectroscopy is
a label-free, non-destructive technique that can be applied to a vast range of biological …

Solution-phase hydrogen/deuterium exchange (HDX) coupled to mass spectrometry (MS) is
a widespread tool for structural analysis across academia and the biopharmaceutical …

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 …

Protein biopharmaceuticals are macromolecules with a therapeutic effect, commonly
produced by the recombinant DNA technology. They have emerged as important …

Fc‐Fusion proteins represent a successful class of biopharmaceutical products, with already
13 drugs approved in the European Union and United States as well as three biosimilar …

Biologic drugs are highly complex molecules produced by living cells through a multistep
manufacturing process. The key characteristics of these molecules, known as critical quality …

Highlights•The CHO genome suffers from chromosomal rearrangements and other stability-
related issues.•The CHO cell instability phenotype is characterized by titer instability and …

Preservation of the integrity of macromolecular higher-order structure is a tenet central to
achieving biologic drug and vaccine product stability toward manufacturing, distribution …