Sign up for CuriRx’s Complimentary Lunch & Learn on November 9 at MassBio!

Join CuriRx for a complimentary lunch & learn about our CuriLytics® platform!

CuriLytics®: De-risking CMC characterization
by using high-resolution mass spectrometry

Date: Tuesday, November 9th, 2021

Time: 12:00-1:00 pm

Place: MassBio Hub
700 Technology Square, 4th Floor
Cambridge, MA 02139

Reserve your seat now

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.