ultraDAWN™ by Waters | Wyatt Technology

Manufacturer Waters | Wyatt Technology  |  Available Worldwide

A breakthrough in process analytical technology for production of nanoparticles, biopharmaceuticals and polymers


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ultraDAWN™
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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

Product Overview

ultraDAWN™ by Waters | Wyatt Technology product image

ultraDAWN™

Manufacturer Waters | Wyatt Technology  |  Available Worldwide

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