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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Mario DiPaola is senior scientific director at Charles River Laboratories, Woburn, MA.
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.