Real-time protein analytics for drug quality assessment has been a long held goal in the development and manufacturing of biopharmaceuticals. Frequent testing is required because biopharmaceuticals are produced in living cells that often introduce unintended structural modifications that can affect efficacy and toxicity. Current testing systems are cumbersome and do not provide the throughput and real-time protein analytics that today’s rapidly growing biopharma industry desperately needs.
Intabio is developing the Blaze™ system to address this unmet need. Blaze utilizes a proprietary microchip technology to seamlessly integrate capillary isoelectric focusing (cIEF) with a mass spec, two pillars of analytical methods in biopharmaceutical development and manufacturing. The Blaze solution includes a bench-top instrument, microfluidic device, MS-compatible reagents kit and software. Blaze utilizes lab-on-a-chip functionality to integrate (1) separation of protein isoforms by cIEF, (2) real-time, full separation channel imaging of protein isoforms for detection and quantification, and (3) delivery of each separated isoform by electrospray into an adjacent mass spectrometer to provide molecular identity. Blaze has the flexibility to connect to a number of mass spectrometers for characterization.
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, shortens analytical timelines, and reduces risk of costly therapeutic development failures.
Intabio’s breakthrough Blaze system uniquely integrates the analytical techniques of separation, quantitation, and molecular mass characterization into a seamless process. Because the Blaze system provides an analysis in only minutes as compared with the days or weeks required with current technologies, biopharmaceutical scientists will be able to characterize protein drug quality in real-time and on hundreds more samples than is currently possible. By enabling the interrogation of product quality much earlier in the development process, the Blaze system provides invaluable insights for key development decisions and can reduce the risk of downstream bio-production issues.
Direct interface to MS
96-well plate or 48 vial with autosampler; unattended operation
280 nm absorbance; whole separation channel detection
Data analysis software
Automated pI calibration; Peak correlation with mass spectra; Data export
Charge Heterogeneity Assay Kit
1 Microfluidic consumable
Reagents for both IEF and MS
pI Standards and MS Calibrant
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.
Director of Engineering
This high-impact individual will lead hardware development for Intabio’s first commercial platform, an analytical system that utilizes a proprietary microchip technology to separate, quantitate, and transfer intact biotherapeutic proteins by electrospray into a mass spectrometer (MS) for molecular identification. The Director of Engineering will oversee internal engineers, expert contractors, and commercial design/manufacturing teams to bring Intabio’s products to market in an efficient, timely manner. The Director of Engineering reports to the Vice President, Product Development.
Scientist, Mass Spectrometry
This highly distinguished individual will bring their industry experience in developing electrospray protocols and equipment. This position reports to the CTO.
This high-impact individual will be part of the engineering team developing Intabio’s first commercial platform, an analytical system that utilizes a proprietary microchip technology to separate, quantitate, and transfer intact biotherapeutic proteins by electrospray into a mass spectrometer (MS) for molecular identification. The Senior Engineer be a key team member designing the Blaze instrument and cartridge.
As part of a multi-disciplinary R&D team, the Process Technician/Engineer will be responsible for assisting Process Development and Engineering consumable microfluidic products. The ideal candidate will have a proven track record of productivity and attention to detail. Candidates must be able to be open to learn other process disciplines as the company grows.
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