ultraDAWN™ - Real-Time Product Attributes for Bioprocess Monitoring and Control

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