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Justin Godinho

Investigator, Drug Substance and Product Analysis, GlaxoSmithKline

Challenges? As a chromatographer, I believe the biggest analytical challenge is the increasing complexity of biopharmaceuticals. Characterization of large therapeutic proteins including monoclonal antibodies, antibody drug conjugates, bispecific antibodies, and coformulations offers a rich and challenging set of analytical chromatography hurdles.

Predictions? I believe there will be increased demand for simultaneous characterization of large proteins and their supporting sample constituents. Currently, a series of separation techniques is required for complete analytical characterization. We have seen some research directions shift towards innovative methods to elucidate multiple critical quality attributes simultaneously. I also expect greater adoption and drive towards multidimensional separation technologies and MS based instrumentation in QC settings to safely deliver well-characterized molecules to patients with fewer more comprehensive analytical tests.

Advice? Find opportunities to collaborate. More specifically, seek out colleagues that have different skill sets. Your work will benefit if you are challenged to think differently.

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