Improving and de-risking the overall drug development path from Phase I clinical trials to approval requires advanced analytical assessment of critical quality attributes. Modern biopharmaceutical drugs, such as recombinant proteins, monoclonal antibodies (mAb), bispecific antibodies, vaccines, antibody drug conjugates (ADCs), oligonucleotides and Gene therapy (AAV’s) are very complex molecules. Characterizing and monitoring these compounds for Chemistry, Manufacturing, and Controls (CMC) and other quality control environments can present a significant challenge.
With this webinar, Jon DeGnore, Associate Director, Analytical Development at CuriRx, will discuss the use of high-resolution accurate-mass mass spectrometry (HRAM-MS) offering a powerful way of overcoming these challenges. Chromatographic separation combined with the sensitivity and specificity of Orbitrap mass spectrometry yields greater insight in critical quality attributes that can be combined with a battery of orthogonal characterization methods for improved understanding of drug products. HRAM-MS provides direct measurement of critical quality attributes of protein candidates at the individual residue level for detailed understanding of how changes in process or production affect a drug product.
Case studies will be discussed.
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