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 …

The pharmaceutical industry is one of the most regulated industries worldwide, since the
drug products have to be safe and effective. The levels of impurities and degradation …

Glycans are key players in many biological processes. They are essential for protein folding
and stability and act as recognition elements in cell–cell and cell–matrix interactions. Thus …

N-glycosylation of therapeutic antibodies starts as a co-translational step followed by a set of
post-translational modifications and is considered as one of the critical quality attributes …

Over the past few years, loss of patent protection for blockbuster monoclonal antibody (mAb)
drugs has caused a significant shift in the pharmaceutical industry towards the development …

The identification and quantification of post-translational modifications (PTMs) is a crucial
step required during the development of therapeutic proteins. In particular, the …

Modern size exclusion chromatography (SEC) can be defined by the use of relatively small
columns (eg, 150× 4.6 mm) packed with sub-3 μm particles, allowing a 3-to 5-fold increase …

Abstract Antibody Drug Conjugates (ADCs) are innovative biopharmaceuticals gaining
increasing attention over the last two decades. The concept of ADCs lead to new therapy …

Background Therapeutic monoclonal antibodies (mAbs) comprise a large structural
variability with respect to charge, size and post-translational modifications. These critical …

Therapeutic monoclonal antibodies (mAbs) are dominating the biopharmaceutical field due
to the fact of their high specificity in the treatment of diverse diseases. Nevertheless, mAbs …