The Production of Biopharmaceuticals with the ultraDAWN

Wyatt Technology’s ultraDAWN™ is an innovation in process analytical technology for manufacturing of biopharmaceuticals, polymers, and nanoparticles.

Real-Time Multi-Angle Light Scattering

By quantifying multi-angle light scattering, ultraDAWN performs real-time reporting of weight-average molecular weight (Mw) and rms radius (Rg). Critical quality attributes (CQAs) can be directly monitored using real-time multi-angle light scattering (RT-MALS), offering quick feedback on process and product quality.

Advantages of RT-MALS

  • Increases yield and minimizes overall time taken until the release of lot
  • Speeds up process development and scale-up
  • Maintains product quality with confidence

Where MALS and PAT Meet

The ultraDAWN is an exclusive member of the DAWN® range of MALS instruments. In contrast to other MALS instruments from Wyatt Technology, ultraDAWN is not intended for use in the analytical lab, but rather to be used in pilot plants and production environments. Molar mass and size are calculated and reported by using the OBSERVER™ software, 30 times per minute.

PAT instrumentation is widely utilized to monitor process parameters such as pressure, temperature, pH, and feedstock, which are indirectly related to the properties and quality of the product. Wyatt Technology’s UltraDAWN completely transforms process development through direct and continuous measurements of actual product properties.

The ultraDAWN is equipped with a smart user interface that indicates the molar mass and size together with system health diagnostics. It also has photodetectors provided at 18 scattering angles, including one more to measure light that is transmitted through the flow cell. The instrument offers a solution for:

  • Real-time monitoring of Rg from 10 to 250 nm and Mw from 103 to 109 g/mol. For molar mass analysis, the existing version of OBSERVER™ software necessitates fixed analyte concentration and solvent composition.
  • Initiating critical alarms or process endpoints
  • Instant detection of particulate contamination

Process Integration Options

  • In-line or on-line configuration
  • Process or slipstream flow rates from 0.1 to 5 mL/minute
  • Integration with production control software through OPC

 

 

Image Credit: Wyatt Technology

Real-Time Operation

In-line

In the case of continuous processes that happen at flows below 5 mL/minute—for example, microfluidic drug encapsulation or chromatographic purification steps—in-line RT-MALS offers the shortest feedback loop while the entire process stream is sampled by ultraDAWN.

On-line

If processing occurs inside a fixed volume like a homogenizer, or if the process flow is more than 5 mL/minute, a bypass stream is diverted from the manufacturing process to the ultraDAWN. RT-MALS data are generated in near-real time.

At-line/off-line

For in-depth analysis, it is possible to characterize products by using methods such as FFF-MALS or SEC-MALS. These methods offer comprehensive, high-resolution distributions of molar mass and size, although not in real time. A typical DAWN® MALS instrument is used in combination with an Eclipse™ field-flow fractionation system or an SEC system.

 

 

Image Credit: Wyatt Technology