CuriRx, Inc., a leading contract research (CRO) and product development organization, announced the launch of their new CuriLytics™ platform with High-Resolution Chemistry Manufacturing and Control (CMC) analytical services. Led by CuriRx's team of industry experts and state-of-the-art high-resolution Orbitrap mass spectrometry instrumentation, the CuriLytics™ platform provides support to developers of complex biotherapeutics.
Improving and de-risking the overall drug development path from Phase I clinical trials through approval requires advanced analyses 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 products (e.g., AAV's) are very complex molecules. Characterizing these molecules can present a significant challenge.
By using high-resolution mass spectrometry and a battery of orthogonal characterization methods, CuriLytics™ offers a powerful way to overcome these challenges, providing greater insight in characterization and improved understanding of biotherapeutic drugs. CuriLytics™ identifies quality attributes of protein candidates at the individual residue level, offering a detailed understanding of how changes in process or production affect a drug product.
CuriRx CEO Indu Javeri remarked, "Analytical methods to characterize and assess highly complex biotherapeutics have struggled to keep up, putting many drug development programs at risk. The CuriLytics™ platform is designed to provide confidence to biotherapeutic developers from discovery to regulatory approval."
CuriRx is planning to hold a webinar on "De-risking product development by using high-resolution mass spectrometry for proteomic characterization" in October, 2021.
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