Antibodies and antibody-derived macromolecules have established themselves as the
mainstay in protein-based therapeutic molecules (biologics). Our knowledge of the structure …

There are many factors that can influence the pharmacokinetics (PK) of a mAb or Fc-fusion
molecule with the primary determinant being FcRn-mediated recycling. Through Fab or Fc …

The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in
the context of drug development. Topics covered include an overview of antibody …

Quality by design (QbD) is a global regulatory initiative with the goal of enhancing
pharmaceutical development through the proactive design of pharmaceutical manufacturing …

The convenience of subcutaneous (SC) administration and the increasing interest in
monoclonal antibody (mAb)-based therapies for chronic diseases, hint their potential for SC …

The development of recombinant therapeutic proteins has been a major revolution in
modern medicine. Therapeutic-based monoclonal antibodies (mAbs) are growing rapidly …

abstract Protein therapeutics represent a diverse array of biologics including antibodies,
fusion proteins, and therapeutic replacement enzymes. Since their inception, they have …

Protein complexes are the functional machines in the cell and are heterogeneous due to
protein sequence variations and post-translational modifications (PTMs). Here, we present …

Biotherapeutics is a rapidly growing drug class, and over 200 biotherapeutics have already
obtained approval, with about 50 of these being approved in 2015 and 2016 alone. Several …

Lowering the isoelectric point (pI) through engineering the variable region or framework of
an IgG can improve its exposure and half-life via a reduction in clearance mediated through …