Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
News|Articles|September 29, 2021
- Pharmaceutical Technology's In the Lab eNewsletter, October 2021
- Volume 16
- Issue 10
CuriRx Launches CuriLytics Platform
Author(s)Pharmaceutical Technology Editors
CuriRx’s CuriLytics platform is a mass spectrometry instrument that will support complex biotherapeutics development.
Advertisement
CuriRx, a contract research and product development organization, announced the launch of their CuriLytics platform on Sept. 21, 2021. The CuriLytics platform is designed to support the development of complex biotherapeutics.
CuriLytics uses high-resolution mass spectrometry and various orthogonal characterization methods to characterize modern biopharmaceutical drugs. This allows it to identify quality attributes of protein candidates at the individual residue level. It can analyze complex molecules such as recombinant proteins, monoclonal antibodies, or antibody drug conjugates, among others.
"Analytical methods to characterize and assess highly complex biotherapeutics have struggled to keep up, putting many drug-development programs at risk,” said CuriRx CEO Indu Javeri in a company press release. “The CuriLytics platform is designed to provide confidence to biotherapeutic developers from discovery to regulatory approval."
Source: CuriRX
Articles in this issue
about 5 years ago
Advancing Detection of Unknown Impuritiesabout 5 years ago
LabVantage Solutions Now Offers LabVantage Enterprise SaaSabout 5 years ago
Gyros Protein Technologies Announces New Titer Kitabout 5 years ago
In Vivo Falls Behind In Vitro for Adventitious Agent Testingabout 5 years ago
Vector Laboratories Closes $124 Million BuyoutAdvertisement
Related to this article
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Xiaoling Li, University of the Pacific, discusses how 3D-printed tablets combine multiple APIs and release profiles, scale out instead of up, and use layer-by-layer scanning.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
3
RRP Accelerated Approval: What VOCERYQ Means for Manufacturing Teams
4
Who Answers for Your Data? Building a Life Sciences Data Mesh
5