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.
Categories
Assays
Equipment and Supplies
Project status
100% Completed

Industry Need

The traditional two-step workflow – iCIEF followed by MS – has been cumbersome and low capacity, creating a bottleneck in protein analytics that can lead to costly development delays and bioproduction failures. 

Solution

Intabio developed the Blaze Microchip iCIEF-MS System to address the critical bottleneck in protein analysis.

Outputs/Deliverables

  • Develop Blaze methods for six mAb drug samples. Demonstrate reproducibility and comparability with legacy partner data. Present data to partners.
  • Query partners on MS integration needs. Design and test additional MS adaptors.
  • Hold workshop with partners to assess requirements for Blaze in-line bioreactor analytics.

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.

Publications

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Project Lead

Intabio

Intabio

Participating Organizations

Bristol-Myers Squibb

Bristol-Myers Squibb

Genentech, Inc.

Genentech, Inc.

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono