Blaze™ Microchip System for Real-Time Characterization of Intact Biopharmaceutical

The goal of this NIIMBL project is to align the powerful technology BlazeTM instrument system for real-time protein analysis with the most urgent needs of biopharma. This will include evaluating assay performance with Tier 1 partner samples.

Project status

100% Completed

Solution

Performance Period: 4/2/2019 to 9/30/2020

The BlazeTM instrument system for real-time protein analysis can potentially solve the critical bottleneck of product quality assessment during bioproduction, by enabling the development of more biopharmaceuticals in less time and reducing the risk of costly bioproduction failures that can delay the availability of these important drugs to patients. The Blaze system can accomplish an analysis in minutes rather than weeks, accelerating analytical throughput by 100-fold. Intabio’s proprietary microchip technology is the first system to seamlessly integrate the detection of protein structural variants by charge heterogeneity analysis with in-line mass spectrometer analysis.

The goal of this NIIMBL project is to align this powerful technology with the most urgent needs of biopharma. This will include evaluating assay performance with Tier 1 partner samples. In addition, based on input from working groups with Tier 1 partners, we will determine the optimal software tools required for analysis of the resulting cIEF and MS data, develop an MS adaptor to connect Blaze physically to an additional mass spec of interest to the NIIMBL members, and perform a needs assessment for in-line bioreactor analysis.

The Blaze system is currently at MRL4 and is expected to achieve MRL6 at the completion of this project.

Impacts

Develop an in-line application for Blaze instrumentation using detection of protein structural variants by charge heterogeneity analysis with in-line mass spectrometer analysis of enable product quality assessment during bioproduction.