Method and system for providing real-time, in situ biomanufacturing process monitoring and control in response to IR spectroscopy
First Claim
1. A method for controlling a biomanufacturing process for a biomolecule, comprising the steps of:
- enabling detection of an infra-red spectra in situ and in real-time during at least one stage of said biomanufacturing process; and
generating at least one control signal in response to the detected infra-red spectra, wherein said control signal enables a control step in said biomanufacturing process.
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Abstract
A method and system for providing real-time, biomanufacturing process monitoring and control in response to infra-red (IR) spectroscopic fingerprinting of a biomolecule. IR spectroscopy is used to fingerprint an active biomolecule in situ in a biomanufacturing process. In one embodiment, Fourier Transform Infra-red spectroscopy (FTIR) is used to determine whether an active or aged biomolecule is present in stages of a biomanufacturing process. In one preferred example, the biomanufacturing process manufactures a biomaterial in bulk. The biomanufacturing process has four stages: bioproduction, recovery, purification, and bulk storage. FTIR spectroscopy is used to monitor the optimization of each process step by providing feedback controls, and to fingerprint in real-time, in situ whether active biomolecules are present in each stage.
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Citations
38 Claims
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1. A method for controlling a biomanufacturing process for a biomolecule, comprising the steps of:
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enabling detection of an infra-red spectra in situ and in real-time during at least one stage of said biomanufacturing process; and
generating at least one control signal in response to the detected infra-red spectra, wherein said control signal enables a control step in said biomanufacturing process. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for controlling a biomanufacturing process for a biomolecule, comprising the steps of:
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detecting an infra-red spectra in situ and in real-time during at least one stage of said biomanufacturing process; and
generating at least one control signal in response to the detected infra-red spectra, wherein said control signal enables a control step in said biomanufacturing process. - View Dependent Claims (23, 24, 25, 26, 28, 29, 30, 31, 32)
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27. A method for monitoring in real-time a biomolecule formulated in a storage solution placed in a bulk container, comprising the steps of:
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detecting an infra-red spectra of the biomolecule in situ and in real time; and
generating a bioactivity indication signal in response to the detected infra-red spectra, wherein the bioactivity indication signal provides an indication of the degradation of the biomolecule during storage.
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33. A system for monitoring in real-time a biomolecule formulated in a storage solution placed in a bulk container, comprising:
an FTIR spectrometer, coupled to that bulk container, that detects an infra-red spectra of the biomolecule in situ and in real time, and generates a bioactivity indication signal in response to the detected infra-red spectra, wherein the bioactivity indication signal provides an indication of the degradation of the biomolecule during storage. - View Dependent Claims (34, 36, 38)
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35. A method for automated, accelerated storage studies of a biomolecule in an array of wells in real-time, comprising the steps of:
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performing FTIR measurements of the biomolecule in the array of wells at varying temperatures;
determining bioactivity ratios based on said FTIR measurements;
generating a multi-dimensional map of stability parameters including the bioactivity ratios; and
finding areas of stability parameters associated with maximum stability.
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37. A system for automated, accelerated storage studies of a biomolecule in an array of wells in real-time, comprising:
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an accelerated storage analyzer; and
a FTIR spectrometer that performs FTIR measurements of the biomolecule in the array of wells at varying temperatures in response to signals from said accelerated storage analyzer;
wherein said accelerated storage analyzer determines bioactivity ratios based on said FTIR measurements, generates a multi-dimensional map of stability parameters including the bioactivity ratios, and finds areas of stability parameters associated with maximum or near maximum stability.
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Specification