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.
Intabio’s breakthrough Blaze system uniquely integrates the analytical techniques of charge heterogeneity analysis, isoform quantitation, and molecular mass characterization into a seamless process. The Blaze system includes a bench-top instrument, a microchip consumable and reagent kits. The system features a unique isotachophoretic peak mobilization strategy that preserves, and often enhances, icIEF peak resolution during mobilization to the MS. Blaze icIEF peak profiles closely match results generated using traditional cIEF systems, while additionally providing structural information for the basic, neutral, and acidic charge variants. The integrated icIEF-MS system is ideal for determining multiple Critical Quality Attributes for intact biotherapeutic proteins in a single, rapid assay, including
· Molecular identity confirmation
· Glycoform analysis
· Charge variant determinations such as terminal lysine variants, amino acid deamidation, and methionine oxidation
Data demonstrating Intabio’s successful integration of the Blaze system to Bruker’s compact QTOF have been presented at several scientific conferences. Intabio currently is working to integrate with other leading high-resolution MS systems used for intact biopharmaceutical analysis.
Commercial release of the Blaze system is targeted for the second half of 2020.
Lena is responsible for the company’s financing, corporate and business development strategy and execution. She was previously the CEO, President and co-founder of Rogne Biosciences, a therapeutic dermatology company. Lena has extensive management experience in companies developing and commercializing microfluidic-based products. She was the Vice-President of Corporate Development of On-Q-ity, a microfluidic-based, cancer diagnostic device company, and was also the Director of Business Development at Caliper Technologies, a microfluidic platform company developing analytical instrumentation systems for life science and diagnostic markets.
Lena has 20 years of industry experience, and has advanced the strategic objectives as an operational business consultant for emerging companies across therapeutic, diagnostic and life science sectors. She began her business career at Millennium Pharmaceuticals, following a post-doc in yeast genetics at Harvard.
Ian is responsible for all engineering and product development efforts at Intabio. He was recently Director of Engineering at Thermo Fisher Scientific and led the development of the SeqStudio™ Genetic Analyzer. Ian has extensive experience in developing life science tools and technologies at Life Technologies, Oxonica, Surromed and Affymetrix. At Life Technologies he led the development of the 5500W next generation sequencing instrument and other qPCR products. As VP of Engineering at Oxonica he led the R&D efforts for the company’s security printing business that was sold to Cabot Materials in 2010. At Affymetrix he was engineering lead for the first DNA array scanner developed in partnership with Molecular Dynamics.
A 20 plus year veteran of the industry he brings core system engineering, technology development and project management leadership to Intabio. He has multiple patents and publications spanning the fields of genetic analysis, optics, in-vivo imaging, nanomaterials and security printing. He has a BASc in Mechanical Engineering from the University of Toronto and an M.Eng in Engineering Physics from Cornell.
Erik is the inventor of Intabio’s microfluidic-based innovations, and is responsible for advancing the technology and the overall development of the BlazeTM system. Erik has spent over 16 years developing microfluidic tools for the analysis of proteins and nucleic acids. Prior to Intabio, Erik was the Director of Systems Integration at ProteinSimple where he led the R&D team developing the Simple Western capillary immunoassay from invention to launch, and also led product support for the iCE3 capillary-based IEF system. Prior to ProteinSimple, he was the Program Manager at Caliper Life Sciences, where he led the system integration for a microfluidic research system, developed chip designs for customer applications, and managed application development collaborations with pharmaceutical partners. Erik was also an early employee at Affymetrix and Combimatrix, where his responsibilities included designing instrumentation, developing synthesis methods, managing the DNA array production facility, and collaborating on novel array applications. Erik is also a registered patent agent.
Wally has been active in the Silicon Valley life sciences start-up ecosystem for 30 years, including leadership positions at Pall/ForteBio (acquired by Danaher), ProteinSimple (acquired by Bio-Techne), Caliper Life Sciences (acquired by PerkinElmer) and Dionex (acquired by Thermo Fisher). At ProteinSimple, Wally was VP of Marketing during the creation of its first product lines, participated in the acquisition and integration of multiple technology businesses, and ultimately led the Biologics Division as General Manager. He earned his Ph.D. in Chemistry at Cornell University, followed by Postdoctoral training in Cancer Biology at SRI International. Immediately before joining Intabio, Wally fulfilled his long-held aspiration of returning to cancer research, leading The Jackson Laboratory’s In Vivo Pharmacology service organization from 2014-2018.
Scientist, Mass Spectrometry
This individual will bring their industry experience in developing and running analytical assays for mAbs, developing electrospray protocols and will be a key contributor to the development of Intabio’s cIEF-MS integrated assay and instrument system. This position reports to the CTO.
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