The role in human health of therapeutic proteins in general, and monoclonal antibodies
(mAbs) in particular, has been significant and is continuously evolving. A considerable …

Accelerated development of new therapeutics in an increasingly competitive landscape
requires the use of high throughput analytical platforms. In addition, the complexity of novel …

Owing to rapid growth in the elucidation of genome sequences of various organisms,
deducing proteome sequences has become imperative, in order to have an improved …

Biologic license applications (BLAs) for 93 therapeutic proteins approved between 2016 and
2020 were analyzed for use of mass spectrometry (MS) as a follow up to a previous study …

Liquid chromatography–mass spectrometry (LC–MS) has been widely used throughout
biotherapeutic development. However, its implementation in GMP-compliant commercial …

Post-translational modifications (PTMs) that impact the safety or efficacy of protein
therapeutics are critical quality attributes (CQAs) that need to be controlled to ensure product …

Photostability testing of therapeutic proteins is a critical requirement in the development of
biologics. Upon exposure to light, pharmaceutical proteins may undergo a change in …

The importance of IgG glycosylation has been known for many years not only by scientists in
glycobiology but also by human pathogens that have evolved specific enzymes to modify …

Recently, cation exchange chromatography (CEX) using aqueous volatile buffers was
directly coupled with mass spectrometry (MS) and applied for intact analysis of therapeutic …

Bispecific antibodies (BsAb) are next-generation, antibody-based pharmaceuticals which
come with a great functional versatility and often a vast structural heterogeneity. Although …