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

Recombinant monoclonal antibodies (mAbs) intended for therapeutic usage are required to
be thoroughly characterized, which has promoted an extensive effort towards the …

Monoclonal antibodies (mAbs) and antibody–drug conjugates (ADCs) are two of the most
important therapeutic drug classes that require extensive characterization, whereas their …

Mass spectrometry (MS) offers unparalleled qualitative and quantitative chemical
information. While increasingly considered a universal detector, the limitations of MS to …

Microbial or endogenous molecular patterns as well as pathogen functional features can
activate innate immune systems. Whereas detection of infection by pattern recognition …

The immunoglobulin degrading enzyme from Streptococcus pyogenes, IdeS, was
discovered as a mechanism by which pathogenic bacteria circumvent antibody mediated …

Antibody drug conjugates (ADCs) are highly cytotoxic drugs covalently attached via
conditionally stable linkers to monoclonal antibodies (mAbs) and are among the most …

Process changes are inevitable in the life cycle of recombinant monoclonal antibody
therapeutics. Products made using pre-and post-change processes are required to be …

Monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) are important large
biotherapeutics (∼ 150 kDa) and high structural complexity that require extensive sequence …

Different manufacturing processes and storage conditions of biotherapeutics can lead to a
significant variability in drug products arising from chemical and enzymatic post-translational …