Coralville, IA, United States
Coralville, IA, United States

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Patent
ASL Analytical, Inc. | Date: 2015-05-12

An optical probe with associated disposable polymer sheath for near-infrared optical interrogation of fluids within bioprocessing vessels by means of transmission or transflection spectroscopy provides for the determination of quantities and parameters of substances in fluids contained within bioprocessing vessels. Associated methods for use of the optical probe and associated sheath to determine quantities of substances in fluids and parameters of fluids during bioprocesses are provided.


Patent
ASL Analytical, Inc. | Date: 2015-05-12

An optical sampling apparatus for disposable flexible bioprocessing vessels includes features for optical interrogation of the vessel contents by means of transmission or transflection spectroscopy. This optical interrogation allows for the determination of quantities and parameters of substances in fluids contained within the vessels during bioprocesses.


An optical sampling apparatus for miniature-scale bioprocessing vessels includes features for optical interrogation of the bioprocessing vessel contents by means of transmission or transflection spectroscopy. This optical interrogation allows for the determination of quantities and parameters of substances in fluids contained within the bioprocessing vessels during bioprocesses. Multiple such bioprocessing vessels with the optical interrogation features may be mounted in a receiver for conducting multiple bioprocesses simultaneously. A translatable probe may be used to interact with each of the bioprocessing vessels in the receiver.


Patent
ASL Analytical, Inc. | Date: 2015-02-26

Methods for continuous, real-time process monitoring and control of bioprocesses by means of near-infrared (NIR) spectroscopy provide analysis of static or flowing fluid streams which may range from clear to highly optically dense. A NIR source passes through a wavelength selector to select one or more spectral segments, which are passed through the fluid stream at a fluid sampling interface and received at a sensor. A wavelength reference material is positioned in the optical path for wavelength axis calibration. Quantification of a plurality of characteristics or parameters of a fluid and suspended solids or cells contained therein may be performed. An all-solid-state implementation of the optical system ensures high robustness for bioprocess monitoring and control.


Patent
ASL Analytical, Inc. | Date: 2015-02-26

An optical apparatus with a single-use, disposable fluid flow cartridge and cell and associated optical interface is employed in determining characteristics of a fluid and/or suspended materials or cells contained therein which are introduced into the apparatus. The optical interface communicates electromagnetic radiation from an optical instrument through the fluid within the cell and to an appropriate sensor within the optical instrument. The interaction of the electromagnetic radiation with the fluid is measured by the signal generated by the sensor. Fluid present within the cell may be static or flowing, allowing both discrete sample measurements and monitoring of continuous processes.


A system and method for continuous, real-time process monitoring and control by means of near-infrared (NIR) spectroscopy provides analysis of static or flowing fluid streams which may range from clear to highly optically dense, including fluids primarily of aqueous composition. A NIR source passes through a wavelength selector to select one or more spectral segments, which are passed through the fluid stream at a fluid sampling interface and received at a sensor. A wavelength reference material is positioned in the optical path for calibration. Quantification of a plurality of characteristics or parameters of a fluid and suspended solids or cells contained therein may be performed. An all-solid-state implementation of the optical system ensures high robustness in laboratory and industrial settings.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2015

DESCRIPTION provided by applicant This Phase I SBIR proposal targets an unmet critical need in Process Analytical Technology PAT the on line quantitation of cell density during the development and manufacture of biopharmaceuticals A non destructive optical method is proposed that operates continuously and in real time during production of biologics in yeast and mammalian cell based bioprocesses This approach leverages an existing innovative Bioprocess Monitor that automatically measures the concentration of key chemicals during production in yeast Pichia pastoris and mammalian cell CHO expression platforms Using near infrared spectroscopic methods this measurement system has demonstrated unprecedented robustness in bioprocess chemical quantitation including industrial operations over a year without need for additional calibration A research plan is proposed to establish the technical and commercial feasibility of quantifying cell density measurements cells mL using this Bioprocess Monitor for Pichia pastoris and CHO cell platforms Specific Aims for this proposal include Evaluation of critical parameters affecting cell density quantitation and alternative measurement combinations Assessment of calibration robustness during live protein expression bioprocesses In addition to the high value of this measurement by itself the combination of quantitative cell density with key nutrient and metabolite concentrations opens an impressive range of fundamental and engineering opportunities For example fundamental measurements of nutrient metabolite utilization per cell can now be evaluated and optimized in real time during the complex bioprocess operation Significant advances in product yield as well as product consistency are anticipated as a result of this technology decreasing the cost and time to market for these complex and valuable medicines PUBLIC HEALTH RELEVANCE Biopharmaceuticals are one of the fastest growing market segments and often the only means for producing medications needed to fight complex diseases like rheumatoid arthritis Crohnandapos s disease and cancer This proposal targets the development and commercialization of a non destructive method for continuously quantifying the cell density during the development and production of biotherapeutics This advanced real time monitoring capability will bridge a critical gap in Process Analytical Technology ultimately reducing costs and time to market of novel and game changing drugs


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2014

This Small Business Innovation Research (SBIR) Phase II project proposes to develop an on-line, probe-based monitor for the real-time, continuous measurement of key analytes in protein expression bioreactors. This directly addresses the need for improved biopharmaceutical production monitoring. The current manual sampling and off-line analysis methods have significant limitations including contamination risks and inherent time delays that severely limit process control. The primary objectives of this effort include the optimization of a high brightness super luminescent diode (SLD) light source and the accompanying optical probe. The SLD provides the light throughput that is required for quantitative in situ measurements, and is perfectly suited for light coupling to an optical-fiber probe. This approach has the added advantage of multiplexing, thereby enabling a single monitor system to simultaneously track analyte concentrations in multiple bioreactors. Both the probe and SLD will be rigorously tested through a series of benchtop and live fermentation evaluations. The ultimate outcome of this effort will be a market-ready, probe-based bioreactor monitor compatible with the major expression platforms in the biopharmaceutical industry. The broader impact/commercial potential of this proposed project, if successful, will be to enable the fast-growing biopharmaceutical industry to make game-changing advances in the development and production of critically important drugs. By replacing current manual chemical measurement methods performed during the production of biopharmaceuticals with automated and continuous monitoring, this real-time probe-based monitor will enable needed improvements in process efficiency, lead to reduced development costs, and accelerate the time to market for state-of-the-art drugs. Because of the high value of these medications, and the driving market need, the commercial potential for this real-time monitor is significant with a specific market niche estimated at $510 million in the U.S. alone, residing in the larger global biologics market estimated at $239 billion by 2015. Ultimately, these advantages will translate to lower costs and greater access for consumers to life-changing medicines.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: STTR PHASE II | Award Amount: 1.11M | Year: 2011

This Small Business Innovation Research (SBIR) Phase II project will further develop a fully hardened, user friendly ASL Pichia monitor for commercial protein production. The Phase I effort demonstrated the commercial feasibility of the continuous, real-time near infrared monitor for tracking metabolite levels and cell density during protein expression with Pichia pastoris. Implementing this technology into an industrial production or process development setting requires the entire system to be hardened and made more user-friendly. All hardware components will be incorporated into a single unit with an embedded computer and the sampling interface will be enhanced to permit continuous monitoring or discrete sampling. Protocols for calibration generation and updating will be established, and performance diagnostics to maximize calibration robustness developed. The final design of the instrumentation will be beta-tested by current Pichia users.

The broader impacts of this research will enable accurate control of bioreactors and enhance optimization efforts, resulting in maximum production yields of highly valued proteins from Pichia. Successful development of ASLs continuous, real-time monitor will enhance the attractiveness of Pichia as a protein expression platform. Acceptance of the monitor by the Pichia community will enhance efforts to develop new biopharmaceuticals and shorten the drug development process. ASLs monitor will catalyze the use of Pichia by enabling more effective control and optimization, thereby driving down healthcare costs and making these bio-therapeutic proteins more widely available. ASLs core monitor technology will be adaptable to broader markets with applications in biotechnology, biomedical, and clinical settings, where reliable, on-line sensing is currently unavailable.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 910.00K | Year: 2014

This Small Business Innovation Research (SBIR) Phase II project proposes to develop an on-line, probe-based monitor for the real-time, continuous measurement of key analytes in protein expression bioreactors. This directly addresses the need for improved biopharmaceutical production monitoring. The current manual sampling and off-line analysis methods have significant limitations including contamination risks and inherent time delays that severely limit process control. The primary objectives of this effort include the optimization of a high brightness super luminescent diode (SLD) light source and the accompanying optical probe. The SLD provides the light throughput that is required for quantitative in situ measurements, and is perfectly suited for light coupling to an optical-fiber probe. This approach has the added advantage of multiplexing, thereby enabling a single monitor system to simultaneously track analyte concentrations in multiple bioreactors. Both the probe and SLD will be rigorously tested through a series of benchtop and live fermentation evaluations. The ultimate outcome of this effort will be a market-ready, probe-based bioreactor monitor compatible with the major expression platforms in the biopharmaceutical industry.

The broader impact/commercial potential of this proposed project, if successful, will be to enable the fast-growing biopharmaceutical industry to make game-changing advances in the development and production of critically important drugs. By replacing current manual chemical measurement methods performed during the production of biopharmaceuticals with automated and continuous monitoring, this real-time probe-based monitor will enable needed improvements in process efficiency, lead to reduced development costs, and accelerate the time to market for state-of-the-art drugs. Because of the high value of these medications, and the driving market need, the commercial potential for this real-time monitor is significant with a specific market niche estimated at $510 million in the U.S. alone, residing in the larger global biologics market estimated at $239 billion by 2015. Ultimately, these advantages will translate to lower costs and greater access for consumers to life-changing medicines.

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