Here we present case studies in development of reliable methods based on mass spectrometry (MS) to characterize a protein–hapten drug substance during late-phase process validation. This protein is modified by succinylation to enable conjugation with an aminated hapten.

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Mass Spectrometric Conjugate Characterization: Process Qualification of Recombinant Protein–Hapten Conjugation

View whitepaper published in BioProcess International’s from November 2016.