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. Intabio has utilized a proprietary microchip platform to seamlessly integrate capillary isoelectric focusing (cIEF) and mass spec, two pillars of analytical methods in biopharmaceutical development and manufacturing. The Blaze solution includes a bench-top instrument, microfluidic chip, reagent kit, and software. Blaze utilizes lab-on-a-chip functionality to integrate (1) separation of protein isoforms by cIEF, (2) real-time, whole-column imaging of protein isoforms for detection and quantitation, and (3) MS sample preparation and delivery of each separated isoform by electrospray into an adjacent mass spectrometer to provide molecular identity. Blaze has the flexibility to run as a stand alone for routine QC, or connected to a mass spectrometer 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 delivers improved productivity, shortened analytical timelines, and reduced risk of costly therapeutic development failures.
Intabio’s breakthrough Blaze system uniquely integrates the analytical techniques of separation, quantitation, and molecular mass determination into a seamless process. Because the Blaze instrument 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 bioproduction issues. Blaze has the flexibility to run as a stand alone for routine QC, or connected to a mass spectrometer for molecular identification.
- Stand-alone (QC mode) or direct interface to MS (Analytical mode)
- 96-well plate with autosampler; unattended operation
- 280 nm absorbance; whole column detection
- Data analysis software
- Automated pI calibration; Peak correlation with mass spectra; Data ex port
Charge Heterogeneity Assay Kit
- 1 Microchip per kit
- Reagents for 100 samples
- pI Standards
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.
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.
Vice President Product Development
This position owns responsibility for overseeing the development and delivery of Intabio’s first commercial platform, an analytical system (hardware/software/consumables) 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 VP Product Development will lead a high performing Product Development team responsible for all phases of product development, including design planning, design verification and validation, prototype testing, and technology transfer for manufacturing scale-up. This high-impact individual reports directly to the CEO, while routinely interacting with our entire leadership team and board, as well as potential strategic partners and investors.
The Product Manager will be responsible for entire product life-cycle of the Blaze system including:
defining the marketing requirements for the product, through customer interactions, internal discussions and feedback from current early access customers; defining the engineering requirements by coordinating with the Product Development team and external vendors; responsibility for project management and execution of the product development plan through product launch by coordinating the efforts of the product development team. The Product Manager will develop marketing collateral and user guides, commercial sales support tools. The Product Manager must be comfortable working in a dynamic, early stage company environment.
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