SG11201808401QA - Real time monitoring of product purification - Google Patents

Real time monitoring of product purification

Info

Publication number
SG11201808401QA
SG11201808401QA SG11201808401QA SG11201808401QA SG11201808401QA SG 11201808401Q A SG11201808401Q A SG 11201808401QA SG 11201808401Q A SG11201808401Q A SG 11201808401QA SG 11201808401Q A SG11201808401Q A SG 11201808401QA SG 11201808401Q A SG11201808401Q A SG 11201808401QA
Authority
SG
Singapore
Prior art keywords
wien
international
muthgasse
real time
potency
Prior art date
Application number
SG11201808401QA
Inventor
Alois Jungbauer
Astrid Dürauer
Nicole Walch
Dominik Sauer
Theresa Scharl-Hirsch
Michael Melcher
Friedrich Leisch
Original Assignee
Boehringer Ingelheim Rcv Gmbh
Sandoz Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boehringer Ingelheim Rcv Gmbh, Sandoz Ag filed Critical Boehringer Ingelheim Rcv Gmbh
Publication of SG11201808401QA publication Critical patent/SG11201808401QA/en

Links

Classifications

    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/04—Programme control other than numerical control, i.e. in sequence controllers or logic controllers
    • G05B19/042—Programme control other than numerical control, i.e. in sequence controllers or logic controllers using digital processors
    • G05B19/0428—Safety, monitoring
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/04—Programme control other than numerical control, i.e. in sequence controllers or logic controllers
    • G05B19/05—Programmable logic controllers, e.g. simulating logic interconnections of signals according to ladder diagrams or function charts
    • G05B19/056—Programming the PLC
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B17/00—Systems involving the use of models or simulators of said systems
    • G05B17/02—Systems involving the use of models or simulators of said systems electric
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/04—Programme control other than numerical control, i.e. in sequence controllers or logic controllers
    • G05B19/10—Programme control other than numerical control, i.e. in sequence controllers or logic controllers using selector switches
    • G05B19/106—Programme control other than numerical control, i.e. in sequence controllers or logic controllers using selector switches for selecting a programme, variable or parameter
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/418—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM]
    • G05B19/4183—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM] characterised by data acquisition, e.g. workpiece identification
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/418—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM]
    • G05B19/41885—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM] characterised by modeling, simulation of the manufacturing system
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B23/00—Testing or monitoring of control systems or parts thereof
    • G05B23/02—Electric testing or monitoring
    • G05B23/0205—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults
    • G05B23/0218—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults characterised by the fault detection method dealing with either existing or incipient faults
    • G05B23/0243—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults characterised by the fault detection method dealing with either existing or incipient faults model based detection method, e.g. first-principles knowledge model
    • G05B23/0254—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults characterised by the fault detection method dealing with either existing or incipient faults model based detection method, e.g. first-principles knowledge model based on a quantitative model, e.g. mathematical relationships between inputs and outputs; functions: observer, Kalman filter, residual calculation, Neural Networks
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16C—COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
    • G16C20/00—Chemoinformatics, i.e. ICT specially adapted for the handling of physicochemical or structural data of chemical particles, elements, compounds or mixtures
    • G16C20/50—Molecular design, e.g. of drugs
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N2021/3595—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using FTIR
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N2021/8411—Application to online plant, process monitoring
    • G01N2021/8416—Application to online plant, process monitoring and process controlling, not otherwise provided for
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/41—Refractivity; Phase-affecting properties, e.g. optical path length
    • G01N21/4133—Refractometers, e.g. differential
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/55—Specular reflectivity
    • G01N21/552—Attenuated total reflection
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6486—Measuring fluorescence of biological material, e.g. DNA, RNA, cells

Landscapes

  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Automation & Control Theory (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Quality & Reliability (AREA)
  • Artificial Intelligence (AREA)
  • Mathematical Physics (AREA)
  • Evolutionary Computation (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Theoretical Computer Science (AREA)
  • Computing Systems (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Processcontrol Parametric release Process optimization Prediction of quantity, purity and potency Statistical model In-situ sensor e.g. temperature measurement Model training Engineering/mechanistic model On-line sensor e.g. UV sensor e.g. SLS On-line sensor e.g. FTIR () INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2017/174580 Al 12 October 2017 (12.10.2017) WIPO I PCT (51) International Patent Classification: G05B 17/02 (2006.01) G05B 23/02 (2006.01) (21) International Application Number: PCT/EP2017/057986 (22) International Filing Date: 4 April 2017 (04.04.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 16163713.7 4 April 2016 (04.04.2016) EP (71) Applicants: BOEHRINGER INGELHEIM RCV GMBH & CO KG [AT/AT]; Dr.-Boehringer-Gasse 5-11, 1121 Wien (AT). SANDOZ GMBH [AT/AT]; Biochemi- estrasse 10, 6250 Kundl (AT). (72) Inventors: JUNGBAUER, Alois; Muthgasse 18, 1190 Wien (AT). DURAUER, Astrid; Muthgasse 18, 1190 Wien (AT). WALCH, Nicole; Muthgasse 18, 1190 Wien (AT). SAUER, Dominik; Muthgasse 18, 1190 Wien (AT). SCHARL-HIRSCH, Theresa; Muthgasse 18, 1190 Wien (AT). MELCHER, Michael; Peter Jordan StraBe 82, 1190 Wien (AT). LEISCH, Friedrich; Peter Jordan StraBe 82, 1190 Wien (AT). (74) Agents: WEINZIERL, Gerhard et al.; Schiweck Weinzi- erl Koch, European Patent Attorneys, Landsberger Strasse 98, 80339 Munich (DE). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) = (54) Title: REAL TIME MONITORING OF PRODUCT PURIFICATION Fig. 1 (57) : The invention relates to a method and device which allows in real-time the determination of concentration, purity and potency of a biological product during purification and/or concentration processes in order to intervene into the process, either for process control or real time release. The properties of the process stream are continuously monitored by at least two online sensors and with the aid of multivariate statistical analysis so that concentration, purity and potency is determined in real time. 1111111111111101110111111111110101111101110101110111111111111101111111111111110111111 W O 20 1717 / 45 80 Al
SG11201808401QA 2016-04-04 2017-04-04 Real time monitoring of product purification SG11201808401QA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16163713 2016-04-04
PCT/EP2017/057986 WO2017174580A1 (en) 2016-04-04 2017-04-04 Real time monitoring of product purification

Publications (1)

Publication Number Publication Date
SG11201808401QA true SG11201808401QA (en) 2018-10-30

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SG10202009671UA SG10202009671UA (en) 2016-04-04 2017-04-04 Real time monitoring of product purification
SG11201808401QA SG11201808401QA (en) 2016-04-04 2017-04-04 Real time monitoring of product purification

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Country Status (9)

Country Link
US (1) US20210149361A1 (en)
EP (1) EP3440518A1 (en)
JP (1) JP6953508B2 (en)
KR (1) KR102344339B1 (en)
CN (1) CN109313419B (en)
AU (1) AU2017248025B2 (en)
CA (1) CA3019979A1 (en)
SG (2) SG10202009671UA (en)
WO (1) WO2017174580A1 (en)

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Also Published As

Publication number Publication date
JP2019522802A (en) 2019-08-15
WO2017174580A1 (en) 2017-10-12
CN109313419A (en) 2019-02-05
EP3440518A1 (en) 2019-02-13
KR20180134942A (en) 2018-12-19
SG10202009671UA (en) 2020-11-27
KR102344339B1 (en) 2021-12-28
CN109313419B (en) 2022-07-15
US20210149361A1 (en) 2021-05-20
AU2017248025A1 (en) 2018-10-25
CA3019979A1 (en) 2017-10-12
JP6953508B2 (en) 2021-10-27
AU2017248025B2 (en) 2022-03-03

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