Description
The ultraDAWN™ instrument provides real-time product attributes for bioprocess monitoring and control. This instrument is a unique multi-angle light scattering (MALS) instrument, designed for monitoring key attributes like aggregation, polymerization, or conjugation 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. ultraDAWN determines the particle concentration for sample in the range of a molecular weight from 103 to 109 g/mol and radius from 10 to 250 nm. It can also determined the Full-total capsid ratio (Vg/Cp), full and empty titer and size of small viral vectors like AAV. 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. OBSERVER’s trigger functionality can be used to control collection of desirable product, reject out-of-spec material, indicate process endpoints or critical alarms.
Use cases include process development and production. Accelerate PD with immediate feedback on product quality when changing conditions such as flow rates, column loading, resin, buffer conditions or process duration. Or 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.
Key Features:
- 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