[Real-Time MALS] ultraDAWN®
|Date : 2020.03.25|
|분류 : Analytical Products > Wyatt Technology|
ultraDAWN® Real-Time MALS for PAT
Monitor and Control Nanoparticle, Biopharmaceutical and Polymer
Production Processes By Measuring Molar Mass and Size in Real Time.
Whereas MALS is traditionally used in the analytical laboratory, it can also be
utilized to develop, monitor and control production processes for
nanoparticles, biopharmaceuticals and polymers. RT-MALS, which determines
weight-average molar mass (Mw) and z-average rms (Rg) in real time, is used
in PAT environments to indicate a process endpoint or flag deviations from
acceptable product attribute values. This technique is implemented with an
ultraDAWN™ MALS instrument and OBSERVER software.
Benefits of RT-MALS :
• Accelerate process development and scale-up
• Increase yield, reduce overall time until lot release
• Maintain product quality with confidence
Traditional PAT monitors process parameters such as concentration, temperature, pH and feedstock. RT-MALS represents a
breakthrough in process analytical technology for production of nanoparticles, biopharmaceuticals and polymers, since critical
quality attributes can be monitored directly, in-line or on-line, for rapid feedback on product and process quality. RT-MALS is
appropriate for advanced products such as polysaccharide antigens, monoclonal antibodies, drug-containing liposomes or
gene-vector VLPs where it quantifies aggregation, size and molecular weight. UltraDAWN measures primary CQAs, when and
where it counts most: on the manufacturing floor.