Biopharmaceuticals are complex and heterogeneous molecules produced by living cells. Due to the nature of their production, they are difficult to manufacture. Growth conditions, purification protocols and formulation requirements can introduce unintended modifications into the protein structure that alter efficacy and toxicity. Testing to monitor for these modifications is required throughout the drug development and biomanufacturing process. Current testing approaches are cumbersome and do not provide the throughput and real-time analytical results that today’s rapidly growing biopharma industry desperately needs to make development and manufacturing decisions.
Intabio’s Blaze™ system was developed to address this unmet need. The Blaze platform performs a comprehensive analysis of antibody and protein biopharmaceutical product quality with 100-fold higher throughput than traditional approaches. Blaze assays use proprietary microchip technology to integrate
(1) Separation of protein isoforms by imaging capillary isoelectric focusing (icIEF)
(2) 280-nm imaging of protein isoforms for quantitation
(3) Electrospray for delivery of the separated isoforms to an adjacent mass spectrometer (MS) for peak identification.
The speed of Blaze system enables detailed characterization of antibody drug candidates throughout the drug development process, from clone selection to commercial production.
Because the Blaze system can provide an analysis of product quality in minutes and can process 100-fold more samples at a fraction of the cost of more traditional processes, Blaze improves productivity, reduces the risk of costly therapeutic development failures, and accelerates development timelines.