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Monoclonal antibodies (mAbs) are naturally occurring complex
biomolecules. New engineering methods have turned mAbs into a
leading therapeutic modality for addressing immunotherapeutic
challenges and led to the rise of mAbs as the dominant class of
protein therapeutics. mAbs have already demonstrated a great
potential in developing safe and reliable treatments for complex
diseases and creating more affordable healthcare alternatives.
Developing mAbs into well-characterized antibody therapeutics that
meet regulatory expectations, however, is extremely challenging.
Obstacles to overcome include the determination and development of
physiochemical characteristics such as aggregation, fragmentation,
charge variants, identity, carbohydrate structure, and higher-order
structure (HOS). This book dives deep into mAbs structure and the
array of physiochemical testing and characterization methods that
need to be developed and validated to establish a mAb as a
therapeutic molecule. The main focus of this book is on
physiochemical aspects, including the importance of establishing
quality attributes such as glycosylation, primary sequence, purity,
and HOS and elucidating the structure of new antibody formats by
mass spectrometry. Each of the aforementioned quality attributes
has been discussed in detail; this will help scientists in
researching and developing biopharmaceuticals and biosimilars to
find practical solutions to physicochemical testing and
characterization.
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