Case Studies Using Mass Spectrometry to Characterize a Protein-Hapten Drug Substance

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Clients often come to us with protein conjugation process needs that can require development of new and innovative methods to assure process validation for conformance manufacturing. Our staff utilizes state-of-the art technologies and instrumentation for a wide range of protein drug manufacturing challenges. These scientists provide the expertise and experience needed to develop accurate and highly reliable assay methods designed specifically to assure successful conformance manufacturing of their protein-hapten or protein-drug conjugate. This white paper illustrates just one example of the technical innovation you can expect from Fujifilm Diosynth Biotechnologies.

A client required an accelerated 16 month program for technology transfer and conformance manufacturing of a hapten-conjugated recombinant protein drug substance. Haptens are small molecules attached to non-immunogenic carrier proteins in order to solicit an immune response specific to the hapten. This required transfer of a validated recombinant protein production process and characterization of the hapten conjugation process. Analytical methods needed to be developed and validated to monitor conjugation and provide release testing of the recombinant protein-hapten conjugate.