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.