For decades, preclinical toxicology was essentially a descriptive discipline in which
treatment-related effects were carefully reported and used as a basis to calculate safety …

Monoclonal antibodies (mAbs) are subject to instability issues linked to their protein nature.
In this work, we review the different mechanisms that can be linked to monoclonal antibodies …

Therapeutic proteins have a propensity for aggregation during manufacturing, shipping, and
storage. The presence of aggregates in protein drug products can induce adverse immune …

Interrogating biological systems is often limited by access to biological probes. The
emergence of “click chemistry” has revolutionized bioconjugate chemistry by providing facile …

The list of ADCs in the clinic continues to grow, bolstered by the success of first two
marketed ADCs: ADCETRIS® and Kadcyla®. Currently, there are 40 ADCs in various …

It has been over four decades since the development of monoclonal antibodies (mAbs)
using a hybridoma cell line was first reported. Since then more than thirty therapeutic …

The elicitation of anti-drug antibodies (ADA) against biotherapeutics can have detrimental
effects on drug safety, efficacy, and pharmacokinetics. The immunogenicity of …

Although it is well known that proteins are only marginally stable in their folded states, it is
often less well appreciated that most proteins are inherently aggregation-prone in their …

Today, potential immunogenicity can be better evaluated during the drug development
process, and we have rational approaches to manage the clinical consequences of …

Glycosylation of the conserved asparagine residue in each heavy chain of IgG in the CH2
domain is known as N-glycosylation. It is one of the most common post-translational …