Improved Methods for Determination of Identity, Purity and Stability

UPLCHPLCImproved Resolution
SEC HPLC UV w/MALSSEC HPLC UVIncreases Sensitivity
Imaged cIEFcIEFIncreased Precision/Resolution
ELISA-ECLELISA-OD/FLRGreater Range, Sensitivity & Multiplex
HILIC UV-MS Glycopeptide MapIndividual Glycan methodsFaster & More efficient
UPLC UHR-MS Peptide MapHPLC UV Peptide MapPTMs, Faster & More Efficient, Improved Resolution
Capilliary Western (WES)ELISAIncreased Precision/Specificity
Microflow Imaging (MFI)HIACSensitivity
Table 3.0: Numerous new analytical approaches and characterization methodologies have emerged that are designed to (better) analyze biopharmaceuticals, allowing scientists to look at monoclonal antibodies much more closely. The FDA expects that applicants use novel methods in lieu of older methods.

This table  is part of: “Evolving CMC Analytical Techniques for Biopharmaceuticals [Article]”
October 21, 2016 | Corresponding Author: Glenn Petrie | doi: 10.14229/jadc.2016.10.21.001

Received: August 19, 2016 | Published online October 21, 2016 | This article has been submitted for peer reviewed by an independent editorial review board.

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