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.
At this Lunch & Learn, Jon DeGnore, Associate Director of 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 into critical quality attributes that can be combined with a battery of orthogonal characterization methods to understand drug products better. HRAM-MS provides direct measurement of critical quality attributes of protein candidates at the individual residue level for a detailed understanding of how changes in process or production affect a drug product.
Case studies will be discussed.