Journal
JOURNAL OF CHROMATOGRAPHY A
Volume 1335, Issue -, Pages 81-103Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.chroma.2013.11.057
Keywords
Chromatography; Mass spectrometry; Biopharmaceutical; Monoclonal antibody; Therapeutic protein
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Protein biopharmaceuticals such as monoclonal antibodies and therapeutic proteins are currently in widespread use for the treatment of various life-threatening diseases including cancer, autoimmune disorders, diabetes and anemia. The complexity of protein therapeutics is far exceeding that of small molecule drugs; hence, unraveling this complexity represents an analytical challenge. The current review provides the reader with state-of-the-art chromatographic and mass spectrometric tools available to dissect primary and higher order structures, post-translational modifications, purity and impurity profiles and pharmacokinetic properties of protein therapeutics. (C) 2013 Elsevier B.V. All rights reserved.
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