The ultraDAWN is a unique multi-angle light scattering (MALS) instrument, designed for monitoring key attributes of macromolecules and nanoparticles such as proteins, biopolymers, gene vectors and nanodrug-delivery vehicles. With its accompanying OBSERVER™ software, ultraDAWN calculates and reports molar mass, size, particle concentration or payload, in real time, up to 300 times per minute.
- Process development: accelerate PD with immediate feedback on product quality when changing conditions such as flow rates, column loading, resin, buffer conditions or process duration
- Production: monitor and control the process based on direct measurements of product attributes, without invoking process models; obtain immediate data on product quality for confidence in sending material to the next unit operation.
OBSERVER can generate a trigger for controlling the process based on allowed values of a product attribute like particle size or gene vector payload. In addition, the real-time data may be fed back to the process controller for control purposes and saved for post-process analytics.
ultraDAWN determines:
- Molecular weight from 103 to 109 g/mol
- Radius from 10 to 250 nm
- Particle concentration for the above size range
- Full-total capsid ratio (Vg/Cp), full and empty titer and size of small viral vectors like AAV
- Product aggregation via increases in molar mass or size
- Presence of impurities via distinct molecular weight or size ranges
OBSERVER’s trigger functionality can be used to:
- Control collection of desirable product
- Reject out-of-spec material
- Indicate process endpoints or critical alarms
Process integration options:
- In-line operation at 1 - 150 mL/min, with response time delay (RTD) below 1 second
- On-line configuration for higher flow rates or for drawing continuously from a homogenizer or reactor vessel, with typical RTD of 0.5 – 3.0 minutes
- Optional integration with production control software via OPC-UA
Applications
- Chromatographic purification of biologics like proteins or viruses
- Microfluidic production of nanoparticles
- Ultrafiltration/diafiltration, final formulation and homogenization of biologics or nanoparticles
- Polymerization, depolymerization or conjugation reactions of biopolymers