There is considerable interest in the pharmaceutical industry toward development of
antibody-based biotherapeutics because they can selectively bind diverse receptors and …

Monoclonal antibody therapeutics are a heterogeneous mixture of glycoforms. Multiple
methods exist for defining the glycan composition and relative abundance of species …

The purpose of this book is to give a concise introduction to development and analysis of
pharmaceutical biologics for those in the pharmaceutical industry who are switching focus …

Biosimilar development has a well‐documented foundation of product quality and extensive
comparative analytics providing the bulk of the “totality of the evidence” that a proposed …

Monoclonal antibodies (mAbs) are being used to prevent, detect, and treat a broad spectrum
of malignancies and infectious and autoimmune diseases. Over the past few years, the …

The development and approval processes of biosimilar mAbs depend on their comparability
to originators. Therefore, analytical comparisons are required to assess structural features …

Biosimilar medicines already on the market may have a primary structure identical to their
reference products (eg, amino acid sequences should be identical). In the case of …

Remarkable methodological advances in the past decade have expanded the application of
liquid chromatography coupled with mass spectrometry (LC/MS) analysis of biotherapeutics …

The extensive analytical characterization of protein biotherapeutics, especially of
biosimilars, is a critical part of the product development and registration. High-resolution …

Monoclonal antibodies (mAbs) are widely applied as highly specific and efficient therapeutic
agents for various medical conditions, including cancer, inflammatory and autoimmune …