CuriRx Launches CuriLytics™ Platform to Provide CMC Analytical Services to Support Complex Biotherapeutic Development Using High Resolution Mass Spectrometry
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.
WILMINGTON, Mass., Sept. 21, 2021 /PRNewswire/ -- CuriRx, Inc., a leading contract research (CRO) and product development organization, announced today 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.
For more information please visit CuriLytics Online.
About CuriRx, Inc.
CuriRx is a leading contract research and drug development organization located in Wilmington, MA. We enable drug developers in the U.S and around the world in their formulation development, lyophilization, cell culture and purification, analytical development, and more. CuriRx has the capacity to produce non-GMP vials for animal studies and non-GMP stability support studies. The key personnel have been involved in successful development projects include HUMIRA®, SYNAGIS®, BLINCYTO® and GATTEX®, etc.
Contact us at [email protected] or visit curirx.com.
Media Contact: Gregory Gironda, Tel. 978-658-2962
HUMIRA® is a trademark of ABBVIE BIOTECHNOLOGY LTD
SYNAGIS® is a registered trademark of Arexis AB c/o Swedish Orphan Biovitrum AB
BLINCYTO ® is a registered trademark of Amgen Inc.
GATTEX ® is a registered trademark of Shire-NPS Pharmaceuticals, Inc., a Takeda company.
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SOURCE CuriRx, Inc.
