• Introduction to the method with a known glycoprotein and confirmation of enzymatic vs. acid-catalyzed release
• Three assay formats:  96-well microplate format using absorbance or fluorescence, and test tubes/cuvettes with a standard fluorometer
• 2 sets of 30 data points

Rapid quantitation of total sialic acid, either free or released from intact glycoproteins:

• Method evaluation with a known glycoprotein (bovine fetuin, certificate of analysis included)

• Comparison between enzymatic and acid-catalyzed cleavage

• Broad range of detection, 200 pmol - 1,000 pmol (fluorescence) to 1 nmol - 5 nmol (absorbance)

• Three assay formats:  96-well microplate format using absorbance or fluorescence, and test tubes/cuvettes with a standard fluorometer

• Enzymatic cleavage allows rapid analysis with minimal, if any, degradation of sialic acid

[TNGS300.1An Enzyme-based Sialic Acid Quantitation Assay for Rapid Screening of Therapeutic Glycoproteins During Process Development:  A Potential Process Analytical Technology]

[TNGS300.2Qualification of a Process Analytical Technology for Quantifying Sialic Acid on Therapeutic Proteins using Two Instrument Platforms]