Although NMR instruments have a relatively high initial capital outlay, all major manufacturers of polysaccharide and conjugate
vaccines now use NMR spectroscopy to assess the identity and purity of the saccharide component, and NMR is a pharmacopoeial
identity test for heparin. It also is proposed as an identity test for peptide hormones. In addition, companies specialized
in providing analytical services to small biotech companies may see opportunities by investing in NMR hardware or purchasing
spectrometer time at NMR laboratories on university campuses that already offer NMR services to local industries. The increasing
availability of these instruments in biopharmaceutical manufacturing environments will allow them to be further exploited
for tests that would otherwise not justify the resources. The growth in the use of NMR spectroscopy in biopharmaceutical quality
control is influencing the acceptance and even expectation of these data by regulatory authorities. The analytical challenges
of biosimilars have increased the need for analytical methods able to distinguish small structural differences between molecules.
NMR spectroscopy meets this criterion, and provides one of a limited number of methods able to provide detailed information
on higher order structure.
The authors thank Cangene for generously providing samples of Leucotropin and Fabian Jameison, PhD, of the US Pharmacopeia
for providing goserelin acetate and goserelin-related compound A.
YVES AUBIN leads the NMR laboratory at the Protein Structure and Analysis Laboratories at BGTD, Health Canada, Ottowa, Canada, 613.941.6155,
CHRISTOPHER JONES is the division head at the Laboratory for Molecular Structure at the National Institute for Biological Standards and Control,
Herts, UK, and DARÓN I. FREEDBERG leads the NMR laboratory at the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville,
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