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J Chromatogr A. 2014 Mar 28;1335:81-103. doi: 10.1016/j.chroma.2013.11.057. Epub 2013 Dec 10.

Modern chromatographic and mass spectrometric techniques for protein biopharmaceutical characterization.

Author information

1
Research Institute for Chromatography (RIC), President Kennedypark 26, 8500 Kortrijk, Belgium. Electronic address: koen.sandra@richrom.com.
2
Research Institute for Chromatography (RIC), President Kennedypark 26, 8500 Kortrijk, Belgium.

Abstract

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.

KEYWORDS:

Biopharmaceutical; Chromatography; Mass spectrometry; Monoclonal antibody; Therapeutic protein

PMID:
24365115
DOI:
10.1016/j.chroma.2013.11.057
[Indexed for MEDLINE]

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