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  • 51.
    Johansson, Leif B. G.
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Kemi. Linköpings universitet, Tekniska högskolan.
    Simon, Rozalyn
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Kemi. Linköpings universitet, Tekniska högskolan.
    Bergström, Gunnar
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Eriksson, Mikaela
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Kemi. Linköpings universitet, Tekniska högskolan.
    Prokop, Stefan
    Charite, Germany.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Heppner, Frank L.
    Charite, Germany.
    Åslund, Andreas
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Kemi. Linköpings universitet, Tekniska högskolan.
    Nilsson, Peter
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Kemi. Linköpings universitet, Tekniska högskolan.
    An azide functionalized oligothiophene ligand - A versatile tool for multimodal detection of disease associated protein aggregates2015Inngår i: Biosensors & bioelectronics, ISSN 0956-5663, E-ISSN 1873-4235, Vol. 63, s. 204-211Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Ligands for identifying protein aggregates are of great interest as such deposits are the pathological hallmark of a wide range of severe diseases including Alzheimers and Parkinsons disease. Here we report the synthesis of an azide functionalized fluorescent pentameric oligothiophene that can be utilized as a ligand for multimodal detection of disease-associated protein aggregates. The azide functionalization allows for attachment of the ligand to a surface by conventional click chemistry without disturbing selective interaction with protein aggregates and the oligothiophene-aggregate interaction can be detected by fluorescence or surface plasmon resonance. In addition, a methodology where the oligothiophene ligand is employed as a capturing molecule selective for aggregated proteins in combination with an antibody detecting a distinct peptide/protein is also presented. We foresee that this methodology will offer the possibility to create a variety of multiplex sensing systems for sensitive and selective detection of protein aggregates, the pathological hallmarks of several neurodegenerative diseases.

  • 52.
    Jungar, Christina
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Neoglycoconjugates as affinity ligands in surface plasmon resonance analysis2001Inngår i: Analytica Chimica Acta, ISSN 0003-2670, E-ISSN 1873-4324, Vol. 449, nr 1-2, s. 51-58Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Neoglycoconjugates, i.e. de novo synthesized conjugates of glycosides and carrier molecules such as proteins or polylipids, were used as affinity ligands in a surface plasmon resonance (SPR) biosensor assay. The affinity of the glycoconjugates, normally in the lower affinity range, was influenced by increasing the number of glycosides bound per carrier protein, the coupling chemistry, and the assay temperature. As a model system, albumin-conjugated A- and B-active blood group oligosaccharides with suitable linker molecules were chosen. Specific monoclonal antibodies were used as analytes to verify the interactive performance. Affinity kinetics of the systems were evaluated from the SPR biosensor data. The results demonstrate that neoglycoconjugates are a good alternative in presenting affinity ligands of small, specific molecules in SPR-based assays with retained specificity and bioavailability. ⌐ 2001 Elsevier Science B.V. All rights reserved.

  • 53.
    Jungar, Christina
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Strandh, M
    University of Kalmar, Kalmar, Sweden.
    Ohlson, S
    University of Kalmar, Kalmar, Sweden.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Analysis of carbohydrates using liquid chromatography-surface plasmon resonance immunosensing systems2000Inngår i: Analytical Biochemistry, ISSN 0003-2697, E-ISSN 1096-0309, Vol. 281, nr 2, s. 151-158Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    An immunosensing system based on surface plasmon resonance (SPR) was used for on-line detection and characterization of carbohydrate molecules separated by high-performance liquid chromatography. These analytes, with or without serum, were continuously separated and analyzed in the combined liquid chromatography-surface plasmon resonance (LC-SPR) system. By using weak and readily reversible monoclonal antibodies, the SPR system allowed specific on-line monitoring of the substances. To increase the specificity of the immunosensor, nonrelevant antibodies were used as reference in a serial flow cell. The sensitivity of the LC-SPR system was dependent on molecular weight of the carbohydrate, affinity of binding, and design of the sensor. (C) 2000 Academic Press.

  • 54. Komaraiah, P.
    et al.
    Kishor PB, Kavi
    Carlsson, Maria
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Magnusson, Karl-Eric
    Linköpings universitet, Hälsouniversitetet. Linköpings universitet, Institutionen för molekylär och klinisk medicin, Medicinsk mikrobiologi.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Enhancement of anthraquinone accumulation in Morinda citrifolia suspension cultures2005Inngår i: Plant Science, ISSN 0168-9452, E-ISSN 1873-2259, Vol. 168, nr 5, s. 1337-1344Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Enhancement of accumulation of anthraquinones in Morinda citrifolia (Noni fruit) suspension cultures was accomplished by treatment with elicitors, by ultrasonication and by controlled feeding of the carbon source in the growth medium. The elicitation was attained by additions of polyunsaturated fatty acids (linoleic acid, α-linolenic acid, arachidonic acid), methyl jasmonate, salicylate and nitric oxide (by addition of sodium nitroprusside to the medium) at different concentrations. The accumulation of anthraquinones in the elicited cultures ranged from 5 to 12 mg/g dry weight of cells, which was two to three-fold of what was attained in control cultures. Treatment by short pulses of ultrasonication enhanced the accumulation up to 2.5-fold after 16 s of sonication. A synergistic effect was achieved by simultaneously applying elicitation and controlled addition of sucrose, that increased the anthraquinone production to 16.74 mg/g of dry weight, which was more than a four-fold increase above the control cultures. The accumulation of the anthraquinones in the M. citrifolia cells was confirmed by confocal laser fluorescence microscopy. Minor fluorescence was observed from the cells in the lag phase (1-3 days), while substantially higher fluorescence was observed at late exponential and stationary phase (10-14 days). Rounder spherical cells emitted less fluorescence than elongated slender cells. The fluorescence was assumed to be a result of autofluorescent properties of the aromatic anthraquinone molecules. © 2005 Elsevier Ireland Ltd. All rights reserved.

  • 55. Komaraiah, P.
    et al.
    Navratil, M.
    Carlsson, Maria
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Jeffers, P.
    Ctr. for Synthesis and Chem. Biology, Department of Chemical Engineering, University College Dublin, Belfield, Dublin 4, Ireland.
    Brodelius, M.
    Dept. of Chem. and Biomed. Sciences, University of Kalmar, SE-391 82 Kalmar, Sweden.
    Brodelius, P.E.
    Dept. of Chem. and Biomed. Sciences, University of Kalmar, SE-391 82 Kalmar, Sweden.
    Kieran, P.M.
    Ctr. for Synthesis and Chem. Biology, Department of Chemical Engineering, University College Dublin, Belfield, Dublin 4, Ireland.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Growth behavior in plant cell cultures based on emissions detected by a multisensor array2004Inngår i: Biotechnology progress (Print), ISSN 8756-7938, E-ISSN 1520-6033, Vol. 20, nr 4, s. 1245-1250Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    The use of a multisensor array based on chemical gas sensors to monitor plant cell cultures is described. The multisensor array, also referred to as an electronic nose, consisted of 19 different metal oxide semiconductor sensors and one carbon dioxide sensor. The device was used to continuously monitor the off-gas from two plant cell suspension cultures, Morinda citrifolia and Nicotiana tabacum, cultivated under batch conditions. By analyzing the multiarray responses using two pattern recognition methods, principal component analysis and artificial neural networks, it was possible to monitor the course of the cultivations and, in turn, to predict (1) the biomass concentration in both systems and (2) the formation of the secondary metabolite, antraquinone, by M. citrifolia. The results identify the multisensor array method as a potentially useful analytical tool for monitoring plant process variables that are otherwise difficult to analyze on-line.

  • 56.
    Komaraiah, Palle
    et al.
    St.Jude Children´s Reserarch Hospital.
    Navratil, Marian
    Linköpings universitet.
    Carlsson, Maria
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Jeffers, Paul
    University College Dublin.
    Brodelius, Maria
    University of Kalmar.
    Brodelius, Peter E.
    University of Kalmar.
    Kieran, Patricia M.
    University of Kalmar.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Growth Behavior in Plant Cell Cultures Based on Emissions Detected by a Multisensor Array2004Inngår i: Biotechnology progress (Print), ISSN 8756-7938, E-ISSN 1520-6033, Vol. 20, s. 1245-1250Artikkel i tidsskrift (Fagfellevurdert)
  • 57.
    Kreij, Karl
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi. Linköpings universitet, Tekniska högskolan.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Clemente, Joao J.
    Cunha, Antonio Eduardo
    Monteiro, Sandra M.S.
    Carrondo, Manuel J.T.
    Hesse, Friedemann
    de los Milagros Bassani Molinas, Maria
    Wagner, Roland
    Merten, Otto-Wilhelm
    Geny-Fiamma, Cecile
    Leger, Wolfgang
    Wiesinger-Mayr, Herbert
    Müller, Dethard
    Katinger, Hermann
    Mårtensson, Per
    Bachinger, Thomas
    Mitrovics, Jan
    On-line detection of microbial contaminations in animal cell reactor cultures using an electronic nose device2005Inngår i: Cytotechnology (Dordrecht), ISSN 0920-9069, E-ISSN 1573-0778, Vol. 48, nr 1-3, s. 41-58Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    An electronic nose (EN) device was used to detect microbial and viral contaminations in a variety of animal cell culture systems. The emission of volatile components from the cultures accumulated in the bioreactor headspace, was sampled and subsequently analysed by the EN device. The EN, which was equipped with an array of 17 chemical gas sensors of varying selectivity towards the sampled volatile molecules, generated response patterns of up to 85 computed signals. Each 15 or 20 min a new gas sample was taken generating a new response pattern. A software evaluation tool visualised the data mainly by using principal component analysis. The EN was first used to detect microbial contaminations in a Chinese hamster ovary (CHO) cell line producing a recombinant human macrophage colony stimulating factor (rhM-CSF). The CHO cell culture was contaminated by Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Candida utilis which all were detected. The response patterns from the CHO cell culture were compared with monoculture references of the microorganisms. Second, contaminations were studied in an Sf-9 insect cell culture producing another recombinant protein (VP2 protein). Contaminants were detected from E. coli, a filamentous fungus and a baculovirus. Third, contamination of a human cell line, HEK-293, infected with E. coli exhibited comparable results. Fourth, bacterial contaminations could also be detected in cultures of a MLV vector producer cell line. Based on the overall experiences in this study it is concluded that the EN method has in a number of cases the potential to be developed into a useful on-line contamination alarm in order to support safety and economical operation for industrial cultivation. © Springer 2005.

  • 58. Lidén, H.
    et al.
    Bachinger, T.
    Gorton, L.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    On-line determination of non-volatile or low-concentration metabolites in a yeast cultivation using an electronic nose2000Inngår i: The Analyst, ISSN 0003-2654, E-ISSN 1364-5528, Vol. 125, nr 6, s. 1123-1128Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    An electronic nose was used for on-line gas phase monitoring of key metabolites in a Saccharomyces cerevisiae cultivation. The metabolites were either non-volatile or present at very low concentrations and therefore not detectable in the gas phase by the sensors in the electronic nose. It was found that it is still possible to make a prediction based on the off-gas emission. Artificial neural networks (ANNs) were trained using data acquired by the gas sensors and reference data obtained from on-line HPLC analyses, from a total of six cultivations to estimate concentrations of the metabolites glucose, glycerol, acetate and acetaldehyde. The ANNs were subsequently validated on an independent set of cultivation data resulting in a prediction accuracy described by the root mean square error (RMSE) of 0.13 (in the range 0-7.33), 0.015 (0.08-0.15), 0.012 (0-0.20) and 0.004 (0-0.11) g L-1, respectively. Data from a cultivation with higher initial glucose concentration were added to the original data and the extended set was used for training an ANN to determine concentration variables at higher concentration ranges than in the first study. The RMSE was 1.2 (0-9.31), 0.016 (0.09-0.20), 0.026 (0-0.19) and 0.010 (0-0.15) g L-1, respectively, when validating the ANNs.

  • 59.
    Luttmann, Reiner
    et al.
    Hamburg University of Appl Science, Germany .
    Bracewell, Daniel G.
    UCL, England .
    Cornelissen, Gesine
    Hamburg University of Appl Science, Germany .
    Gernaey, Krist V.
    Technical University of Denmark, Denmark .
    Glassey, Jarka
    Newcastle University, England .
    Hass, Volker C.
    University of Appl Science Bremen, Germany .
    Kaiser, Christian
    Richter Helm GmbH, Germany .
    Preusse, Christian
    Siemens AG, Germany .
    Striedner, Gerald
    University of Nat Resources and Life Science, Austria .
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Editorial Material: Soft sensors in bioprocessing: A status report and recommendations2012Inngår i: Biotechnology Journal, ISSN 1860-6768, E-ISSN 1860-7314, Vol. 7, nr 8, s. 1040-1048Artikkel i tidsskrift (Annet vitenskapelig)
    Abstract [en]

    The following report with recommendations is the result of an expert panel meeting on soft sensor applications in bioprocess engineering that was organized by the Measurement, Monitoring, Modelling and Control (M3C) Working Group of the European Federation of Biotechnology - Section of Biochemical Engineering Science (ESBES). The aim of the panel was to provide an update on the present status of the subject and to identify critical needs and issues for the furthering of the successful development of soft sensor methods in bioprocess engineering research and for industrial applications, in particular with focus on biopharmaceutical applications. It concludes with a set of recommendations, which highlight current prospects for the extended use of soft sensors and those areas requiring development.

  • 60.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Advances in Micro-Bioreactor Design for Organ Cell Studies2018Inngår i: Bioengineering (Basel, Switzerland), ISSN 2306-5354, Vol. 5, nr 3, artikkel-id 64Artikkel i tidsskrift (Annet vitenskapelig)
  • 61.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Biomechatronic Design for Sensors: Biomechatronic Methodology2011Inngår i: GIT Laboratory Journal, ISSN 1434-2634, Vol. 15, nr 11-12, s. 24-25Artikkel i tidsskrift (Annet vitenskapelig)
    Abstract [en]

    Biomechatronic design combines mechanical and electric product design principles with biotechnology [1]. Systematic conceptual design, used for decades in product development for mechanical products is here adapted to cope with the complexity of biological systems and processes. Typical examples are bioreactors and biosensors. The biomechatronic design facilitates and coordinates the product development work by using a few simple procedures, tools and models. In this report these tools and models are applied on the design of sensor systems used for monitoring and controlling biotechnology production processes.

  • 62.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Biomechatronics for designing bioprocess monitoring and control systems: Application to stem cell production2012Inngår i: Journal of Biotechnology, ISSN 0168-1656, E-ISSN 1873-4863, Vol. 162, nr 4, s. 430-440Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Stem cell production systems need elaborate monitoring and control for meeting requirements on the final cell product. In this article, the use of biomechatronic design methodology for supporting these efforts is described. Biomechatronic design, which is based on a fundamental systematical design approach originating from mechanical engineering, is here applied for investigating how monitoring and control systems can be configured in stem cell manufacturing processes. Results are provided that demonstrate how the biomechatronic design tools are used to compare different process analytical instrumentation resulting in a design layout for the monitoring system for derivation of hepatocytes from human embryonic stem cells. The results can be extrapolated to other stem cell production processes using the same methodology.

  • 63.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Bioreactors : design, operation and novel applications2016Collection/Antologi (Annet vitenskapelig)
    Abstract [en]

    In this expert handbook both the topics and contributors are selected so as to provide an authoritative view of possible applications for this new technology. The result is an up-to-date survey of current challenges and opportunities in the design and operation of bioreactors for high-value products in the biomedical and chemical industries.

    Combining theory and practice, the authors explain such leading-edge technologies as single-use bioreactors, bioreactor simulators, and soft sensor monitoring, and discuss novel applications, such as stem cell production, process development, and multi-product reactors, using case studies from academia as well as from industry. A final section addresses the latest trends, including culture media design and systems biotechnology, which are expected to have an increasing impact on bioreactor design.

    With its focus on cutting-edge technologies and discussions of future developments, this handbook will remain an invaluable reference for many years to come.

  • 64.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Challenges for bioreactor design and operation2016Inngår i: Bioreactors: design, operation and novel applications / [ed] Carl-Fredrik Mandenius, Weinheim: Wiley-VCH Verlagsgesellschaft, 2016, s. 1-34Kapittel i bok, del av antologi (Annet vitenskapelig)
  • 65.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Conceptual Design of Micro-Bioreactors and Organ-on-Chips for Studies of Cell Cultures2018Inngår i: Bioengineering (Basel, Switzerland), ISSN 2306-5354, Vol. 5, nr 3, artikkel-id 56Artikkel, forskningsoversikt (Fagfellevurdert)
    Abstract [en]

    Engineering design of microbioreactors (MBRs) and organ-on-chip (OoC) devices can take advantage of established design science theory, in which systematic evaluation of functional concepts and user requirements are analyzed. This is commonly referred to as a conceptual design. This review article compares how common conceptual design principles are applicable to MBR and OoC devices. The complexity of this design, which is exemplified by MBRs for scaled-down cell cultures in bioprocess development and drug testing in OoCs for heart and eye, is discussed and compared with previous design solutions of MBRs and OoCs, from the perspective of how similarities in understanding design from functionality and user purpose perspectives can more efficiently be exploited. The review can serve as a guideline and help the future design of MBR and OoC devices for cell culture studies.

  • 66.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Design of Monitoring and Sensor Systems for Bioprocesses by Biomechatronic Methodology2012Inngår i: Chemical Engineering & Technology, ISSN 0930-7516, E-ISSN 1521-4125, Vol. 35, nr 8, s. 1412-1420Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Biomechatronic design methodology is discussed for the design of monitoring and sensor systems for biotechnological processes. The bioprocess monitoring systems are examples of complex biomechatronic systems between electronic, mechanical, and biological subsystems, and where in particular the biological parts, through active microbial or cellular components, influence the design solutions in a complex manner. The biomechatronic approach facilitates configuration of the monitoring and sensor systems with production and quality needs in focus, and can by that lead to more efficient design solutions.

  • 67.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Design-of-experiments for development and optimization of bioreactor media2016Inngår i: Bioreactors: design, operation and novel applications / [ed] Carl-Fredrik Mandenius, Weinheim: Wiley-VCH Verlagsgesellschaft, 2016, s. 421-451Kapittel i bok, del av antologi (Annet vitenskapelig)
  • 68.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Recent developments in the monitoring, modeling and control of biological production system2004Inngår i: Bioprocess and biosystems engineering (Print), ISSN 1615-7591, E-ISSN 1615-7605, Vol. 26, s. 347-351Artikkel i tidsskrift (Fagfellevurdert)
  • 69.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Recent developments in the monitoring, modeling and control of biological production systems2004Inngår i: Bioprocess and biosystems engineering (Print), ISSN 1615-7591, E-ISSN 1615-7605, Vol. 26, nr 6, s. 347-351Artikkel, forskningsoversikt (Fagfellevurdert)
    Abstract [en]

    Current trends in the development of methods for monitoring, modeling and controlling biological production systems are reviewed from a bioengineering perspective. The ability to measure intracellular conditions in bioprocesses using genomics and other bioinformatics tools is addressed. Devices provided via micromachining techniques and new real-time optical technology are other novel methods that may facilitate biosystem engineering. Mathematical modeling of data obtained from bioinformatics or real-time monitoring methods are necessary in order to handle the dense flows of data that are generated. Furthermore, control methods must be able to cope with these data flows in efficient ways that can be implemented in plant-wide computer communication systems.

  • 70.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    The role of PAT in Biotechnology2006Inngår i: European pharmaceutical review, ISSN 1360-8606, Vol. 3, s. 69-76Artikkel i tidsskrift (Fagfellevurdert)
  • 71.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Andersson, Tommy B
    Department of Physiology and Pharmacology, Karolinska Institute, Stockholm.
    Alves, Paula M
    IBET, Oeiras, Portugal .
    Batzl-Hartmann, Christine
    Pharmacelsus GmbH, Saarbrücken, Germany.
    Björquist, Petter
    Cellartis AB, Göteborg, Sweden.
    Carrondo, Manuel J. T.
    IBET, Oeiras, Portugal .
    Chesne, Christophe
    BioPredic SA, Rennes, France.
    Coecke, Sandra
    ECVAM, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy.
    Edsbagge, Josefina
    Cellartis AB, Göteborg, Sweden.
    Fredriksson, J. Magnus
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Gerlach, Jörg C.
    Experimental Surgery, Charité Universitätsmedizin, Berlin, Germany.
    Heinzle, Elmar
    Biochemical Engineering, Saarland University, Saarbrücken, Germany.
    Ingelman- Sundberg, Magnus
    Department of Physiology and Pharmacology, Karolinska Institute, Stockholm.
    Johansson, Inger
    Department of Physiology and Pharmacology, Karolinska Institute, Stockholm.
    Kuppers-Munther, Barbara
    Cellartis AB, Göteborg, Sweden.
    Mueller-Vieira, Ursula
    Pharmacelsus GmbH, Saarbrücken, Germany.
    Noor, Fozia
    Biochemical Engineering, Saarland University, Saarbrücken, Germany.
    Zeilinger, Katrin
    Experimental Surgery, Charité Universitätsmedizin, Berlin, Germany.
    Toward Preclinical Predictive Drug Testing for Metabolism and Hepatotoxicity by Using In Vitro Models Derived from Human Embryonic Stem Cells and Human Cell Lines - A Report on the Vitrocellomics EU-project2011Inngår i: ATLA-ALTERNATIVES TO LABORATORY ANIMALS, ISSN 0261-1929, Vol. 39, nr 2, s. 147-171Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Drug-induced liver injury is a common reason for drug attrition in late clinical phases, and even for post-launch withdrawals. As a consequence, there is a broad consensus in the pharmaceutical industry, and within regulatory authorities, that a significant improvement of the current in vitro test methodologies for accurate assessment and prediction of such adverse effects is needed. For this purpose, appropriate in vivo-like hepatic in vitro models are necessary, in addition to novel sources of human hepatocytes. In this report, we describe recent and ongoing research toward the use of human embryonic stem cell (hESC)-derived hepatic cells, in conjunction with new and improved test methods, for evaluating drug metabolism and hepatotoxicity. Recent progress on the directed differentiation of human embryonic stem cells to the functional hepatic phenotype is reported, as well as the development and adaptation of bioreactors and toxicity assay technologies for the testing of hepatic cells. The aim of achieving a testing platform for metabolism and hepatotoxicity assessment, based on hESC-derived hepatic cells, has advanced markedly in the last 2-3 years. However, great challenges still remain, before such new test systems could be routinely used by the industry. In particular, we give an overview of results from the Vitrocellomics project (EU Framework 6) and discuss these in relation to the current state-of-the-art and the remaining difficulties, with suggestions on how to proceed before such in vitro systems can be implemented in industrial discovery and development settings and in regulatory acceptance.

  • 72.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Björkman, Mats
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Monteringsteknik. Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi.
    Biomechatronic Design in Biotechnology: A Methodology for Development of Biotechnological Products2011Bok (Annet vitenskapelig)
    Abstract [en]

    This cutting-edge guide on the fundamentals, theory, and applications of biomechatronic design principles.

    Biomechatronic Design in Biotechnology presents a complete methodology of biomechatronics, an emerging variant of the mechatronics field that marries biology, electronics, and mechanics to create products where biological and biochemical, technical, human, management-and-goal, and information systems are combined and integrated in order to solve a mission that fulfills a human need. A biomechatronic product includes a biological, mechanical, and electronic part. Beginning with an overview of the fundamentals and theory behind biomechatronic technology, this book describes how general engineering design science theory can be applied when designing a technical system where biological species or components are integrated. Some research methods explored include schemes and matrices for analyzing the functionality of the designed products, ranking methods for screening and scoring the best design solutions, and structuring graphical tools for a thorough investigation of the subsystems and sub-functions of products. This insightful guide also:

    • Discusses tools for creating shorter development times, thereby reducing the need for prototype testing and verification
    • Presents case study-like examples of the technology used such as a surface plasmon resonance sensor and a robotic cell culturing system for human embryonic stem cells
    • Provides an interdisciplinary and unifying approach of the many fields of engineering and biotechnology used in biomechatronic design

    By combining designs between traditional electronic and mechanical subsystems and biological systems, this book demonstrates how biotechnology and bioengineering design can utilize and benefit from commonly used design tools-- and benefit humanity itself.

  • 73.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Björkman, Mats
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Monteringsteknik. Linköpings universitet, Tekniska högskolan.
    Mechatronic design methodology for biotechnology products2009Inngår i: New Biotechnology, ISSN 1871-6784, E-ISSN 1876-4347, Vol. 25, nr Suppl. 1, s. S190-S190Artikkel i tidsskrift (Annet vitenskapelig)
    Abstract [en]

    Biotechnology products can be divided into (1) biologics, which comprise those metabolites, biopolymers, and cell structures that are produced through biological processes, and (2) biotechnical machines, which are apparatuses and devices that transform, change, or analyze ‘biological specimens’ for specific purposes, often by using the biological systems per se. The first category has been thoroughly treated in bioengineering theory and practice while the second has been very scarcely investigated.

    In this presentation is described how the general design science theory can be applied when designing a technical system where biological species or components have the key role in the engineering design solutions. We have named these systems bio-mechatronic systems, since they are combined design achievements between traditional electronic and mechanical sub-systems and the biological systems, and where biological molecules and/or active microbial or cellular components influence the design solutions in a complex way.

    The purpose is to demonstrate that biotechnology and bioengineering related design can utilize and benefit from other commonly used design tools in, for example, mechanical and electric engineering. These tools should result in shorter development times and a reduction of the need for prototype testing and verification.

    Four examples will be presented, all well-known biotechnology products in the pharmaceutical and clinical areas: (1) a protein purification system, (2) a bioreactor system, (3) a biosensor instrument, and (4) an embryonic stem cell manufacturing systems.

  • 74.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Björkman, Mats
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Monteringsteknik. Linköpings universitet, Tekniska högskolan.
    Mechatronics design principles for biotechnology product development2010Inngår i: TRENDS IN BIOTECHNOLOGY, ISSN 0167-7799, Vol. 28, nr 5, s. 230-236Artikkel, forskningsoversikt (Fagfellevurdert)
    Abstract [en]

    Traditionally, biotechnology design has focused on the manufacture of chemicals and biologics. Still, a majority of biotechnology products that appear on the market today is the result of mechanical electric (mechatronic) construction. For these, the biological components play decisive roles in the design solution; the biological entities are either integral parts of the design, or are transformed by the mechatronic system. This article explains how the development and production engineering design principles used for typical mechanical products can be adapted to the demands of biotechnology products, and how electronics, mechanics and biology can be integrated more successfully. We discuss three emerging areas of biotechnology in which mechatronic design principles can apply: stem cell manufacture, artificial organs, and bioreactors.

  • 75.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Björkman, Mats
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Produktionsteknik. Linköpings universitet, Tekniska högskolan.
    PAT and QbD aspects on stem cell manufacture2009Inngår i: European Pharmaceutical Review Digital, nr 1, s. 32-37Artikkel i tidsskrift (Fagfellevurdert)
  • 76.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Björkman, Mats
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Industriell Produktion. Linköpings universitet, Tekniska högskolan.
    Scale-up of cell culture bioreactors using biomechatronic design2012Inngår i: Biotechnology Journal, ISSN 1860-6768, E-ISSN 1860-7314, Vol. 7, nr 8, s. 1026-1039Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Scale-up of cell culture bioreactors is a challenging engineering work that requires wide competence in cell biology, mechanical engineering and bioprocess design. In this article, a new approach for cell culture bioreactor scale-up is suggested that is based on biomechatronic design methodology. The approach differs from traditional biochemical engineering methodology by applying a sequential design procedure where the needs of the users and alternative design solutions are systematically analysed. The procedure is based on the biological and technical functions of the scaled-up bioreactor that are derived in functional maps, concept generation charts and scoring and interaction matrices. Basic reactor engineering properties, such as mass and heat transfer and kinetics are integrated in the procedure. The methodology results in the generation of alternative design solutions that are thoroughly ranked with help of the user needs. Examples from monoclonal antibodies and recombinant protein production illuminate the steps of the procedure. The methodology provides engineering teams with additional tools that can significantly facilitate the design of new production methods for cell culture processes.

  • 77.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Brundin , Anders
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Bioprocess Optimization Using Design-of-Experiments Methodology2008Inngår i: Biotechnology progress (Print), ISSN 8756-7938, E-ISSN 1520-6033, Vol. 24, nr 6, s. 1191-1203Artikkel, forskningsoversikt (Annet vitenskapelig)
    Abstract [en]

    This review surveys recent applications of design-of-experiments (DoE) methodology in the development of biotechnological processes. Methods such as factorial design, response surface methodology, and (DoE) provide powerful and efficient ways to optimize cultivations and other unit operations and procedures using a reduced number of experiments. The multitude of interdependent parameters involved within a unit operation or between units in a bioprocess sequence may be substantially refined and improved by the use of such methods. Other bioprocess-related applications include strain screening evaluation and cultivation media balancing. In view, of the emerging regulatory demands on pharmaceutical manufacturing processes, exemplified by the process analytical technology (PAT) initiative of the United States Food and Drug Administration, the use of experimental design approaches to improve process development for safer and more reproducible production is becoming increasingly important. Here, these options are highlighted and discussed with a few selected examples from antibiotic fermentation, expanded bed optimization, virus vector transfection of insect cell cultivation, feed profile adaptation, embryonic stem cell expansion protocols, and mammalian cell harvesting.

  • 78.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi. Linköpings universitet, Tekniska högskolan.
    Derelöv, Micael
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Monteringsteknik. Linköpings universitet, Tekniska högskolan.
    Detterfelt, Jonas
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Monteringsteknik. Linköpings universitet, Tekniska högskolan.
    Björkman, Mats
    Linköpings universitet, Institutionen för ekonomisk och industriell utveckling, Monteringsteknik. Linköpings universitet, Tekniska högskolan.
    PAT and design science2007Inngår i: European Pharmaceutical Review, nr 3, s. 74-80Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Process analyties. technology (PAT) and mechanical design science are interconnected. This article describes how a well-established design modelling approach. The Hubka-Eder model, is applied to the concepis of PAT end quality by design (QBD). The model connects PAT With quality management concepts as defined for PAT by lhe ICH guldelines for quaiity issues. Examples are taken fom biopharmaceutical applications. but lhese are also applicable to other pharmaceutical ingredients (API). Benefits of using a conceptual design modelling approach on PAT and related subjects are discussed and suggestecl as a complementary functionality analysis tool in PAT and quality design pharmaceutical processes.

  • 79.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Graumann, Klaus
    Sandoz GmbH.
    Schultz, Torsten W
    Boehringer Ingelheim Pharma GmbH & Co. KG.
    Premstaller, Andreas
    Sandoz GmbH.
    Olsson, Ing-Marie
    Umetrics AB.
    Petiot, Emma
    Laboratoire des Sciences du Génie Chimique.
    Clemens, Christoph
    Boehringer Ingelheim Pharma GmbH & Co. KG.
    Welin, Mats
    Medical Products Agency.
    Quality-by-design for biotechnology-related pharmaceuticals.2009Inngår i: Biotechnology journal, ISSN 1860-7314, Vol. 4, nr 5, s. 600-9Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    The following article is a report from a workshop on Quality-by-Design (QbD) held at the 7th European Symposium on Biochemical Engineering Science (7 September 2008, Faro, Portugal).The aim of the workshop was to provide an update on the present status of using QbD in biotechnology-related applications in the pharmaceutical industry. The report summarizes the essential parts of the presentations and covers the industrial, academic, and regulatory aspects of QbD. It concludes with recommendations for further work and development.

  • 80.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Gustavsson, Robert
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Mini-review: soft sensors as means for PAT in the manufacture of bio-therapeutics2015Inngår i: Journal of chemical technology and biotechnology (1986), ISSN 0268-2575, E-ISSN 1097-4660, Vol. 90, nr 2, s. 215-227Artikkel, forskningsoversikt (Fagfellevurdert)
    Abstract [en]

    This mini-review discusses how soft sensors can contribute to accomplish FDAs process analytical technology (PAT) ambitions in the manufacture of bio-therapeutics. Focus is on applications with protein-based drugs (proteins, antibodies), but also gene therapy vectors as well as cell cultures are considered where chemical and bio-analytical as well as mathematical and statistical methods are used as tools. An overview of existing soft sensor alternatives and how these can be configured to meet typical industrial needs is provided. It is noted how several of these needs coincide with the PAT regulatory incentives but do also address process economic aspects of bio-therapeutic manufacture. Evaluation of soft sensor alternatives is highlighted in relation to the production targets, quality attributes and the specification of these as well as shortcomings and needs for further improvements.

  • 81.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Gustavsson, Robert
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Soft sensor design for bioreactor monitoring and control2016Inngår i: Bioreactors: design, operation and novel application / [ed] Carl-Fredrik Mandenius, Weinheim: Wiley-VCH Verlagsgesellschaft, 2016, s. 391-420Kapittel i bok, del av antologi (Annet vitenskapelig)
  • 82.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    J Titchener-Hooker, N
    Lund University, Sweden .
    Measurement, Monitoring, Modelling and Control of Bioprocesses Preface2013Annet (Fagfellevurdert)
    Abstract [en]

    n/a

  • 83.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Meyer, Thomas
    MultiChannel Systems GmbH, Reutlingen, Germany.
    High-throughput screening assays to evaluate the cardiotoxic potential of drugs2013Inngår i: High-throughput screening methods in toxicity testing / [ed] Pablo Steinman, John Wiley & Sons, 2013, s. 403-420Kapittel i bok, del av antologi (Annet vitenskapelig)
    Abstract [en]

    "High-throughput assays are part of a paradigm shift, to more cost-effective and reliable methods, in the testing of chemical and drug safety. This book covers methods, data generation, data analysis, and applications in risk assessment for major toxicological assays to help toxicologists apply and understand the benefits and limits of high-throughput testing assays. Each chapter describes method principles and includes detailed information on data generation, data analysis, and applications in risk assessment. The topic is especially timely given Europe's REACH legislation and the US National Research Council"-- 

    "This book describes the high-throughput in vitro methods available for toxicity testing, serving as a guide to scientists working in toxicity evaluation and risk assessment of chemicals and drugs"-- 

  • 84.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Steel, Daniella
    Cellartis AB, Gothenburg, Sweden.
    Noor, Fozia
    Biochemical Engineering, Saarland University, Saarbruecken, Germany.
    Meyer, Thomas
    MultiChannel Systems GmbH, Reutlingen, Germany.
    Heinzle, Elmar
    Biochemical Engineering, Saarland University, Saarbruecken, Germany.
    Asp, Julia
    Department of Clinical Chemistry and Transfusion Medicine, Institute of Biomedicine, the Sahlgrenska Academy, University of Gothenburg, Sweden.
    Arain, Sarina
    PerSens GmbH, Regensburg, Germany.
    Kraushaar, Udo
    Natural and Medical Sciences Institute at the University of Tübingen, Germany.
    Bremer, Susanne
    ECVAM, Institute for Health and Consumer Protection (IHCP), European Commission Joint Research Center, Ispra, Italy.
    Class, Reiner
    Pharmacelsus GmbH, Saarbruecken, Germany.
    Sartipy, Peter
    Cellartis AB, Gothenburg, Sweden.
    Cardiotoxicity testing using pluripotent stem cell-derived human cardiomyocytes and state-of-the-art bioanalytics: a review2011Inngår i: JOURNAL OF APPLIED TOXICOLOGY, ISSN 0260-437X, Vol. 31, nr 3, s. 191-205Artikkel, forskningsoversikt (Fagfellevurdert)
    Abstract [en]

    In this article, recent progress in cardiotoxicity testing based on the use of immortalized cell lines or human embryonic stem cell (hESC) derived cardiomyocytes in combination with state-of-the-art bioanalytical methods and sensors is reviewed. The focus is on hESC-derived cells and their refinement into competent testing cells, but the access and utility of other relevant cell types are also discussed. Recent developments in sensor techniques and bioanalytical approaches for measuring critical cardiotoxicity parameters are highlighted, together with aspects of data evaluation and validation. Finally, recommendations for further research are given.

  • 85.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Titchener-Hooker, Nigel J.University College London, UK.
    Measurement, Monitoring, Modelling and Control of Bioprocesses2013Collection/Antologi (Fagfellevurdert)
    Abstract [en]

    Automated Measurement and Monitoring of Bioprocesses: Key Elements of the M3C Strategy, by Bernhard Sonnleitner Automatic Control of Bioprocesses, by Marc Stanke, Bernd Hitzmann An Advanced Monitoring Platform for Rational Design of Recombinant Processes, by G. Striedner, K. Bayer Modelling Approaches for Bio-Manufacturing Operations, by Sunil Chhatre Extreme Scale-Down Approaches for Rapid Chromatography Column Design and Scale-Up During Bioprocess Development, by Sunil Chhatre Applying Mechanistic Models in Bioprocess Development, by Rita Lencastre Fernandes, Vijaya Krishna Bodla, Magnus Carlquist, Anna-Lena Heins, Anna Eliasson Lantz, Gürkan Sin and Krist V. Gernaey Multivariate Data Analysis for Advancing the Interpretation of Bioprocess Measurement and Monitoring Data, by Jarka Glassey Design of Pathway-Level Bioprocess Monitoring and Control Strategies Supported by Metabolic Networks, by Inês A. Isidro, Ana R. Ferreira, João J. Clemente, António E. Cunha, João M. L. Dias, Rui Oliveira Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm, by Anurag S Rathore, Anshuman Bansal, Jaspinder Hans The Choice of Suitable Online Analytical Techniques and Data Processing for Monitoring of Bioprocesses, by Ian Marison, Siobhán Hennessy, Róisín Foley, Moira Schuler, Senthilkumar Sivaprakasam, Brian Freeland

  • 86.
    Mandenius, Carl-Fredrik
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Wang, Ronghui
    Linköpings universitet, Institutionen för fysik, kemi och biologi. Linköpings universitet, Tekniska högskolan.
    Aldén, Anna
    School of Pure and Applied Natural Sciences, University of Kalmar, SE-391 82 Kalmar, Sweden.
    Bergström, Gunnar
    Linköpings universitet, Institutionen för fysik, kemi och biologi. Linköpings universitet, Tekniska högskolan.
    Thébault, Sabine
    Process Development Purification, Sanofi Pasteur, Campus Merieux 1541, Avenue Marcel Merieux, F-69280 Marcy l’ Etoile, France.
    Lutsch, Charles
    Process Development Purification, Sanofi Pasteur, Campus Merieux 1541, Avenue Marcel Merieux, F-69280 Marcy l’ Etoile, France.
    Ohlson, Sten
    School of Pure and Applied Natural Sciences, University of Kalmar, SE-391 82 Kalmar, Sweden.
    Monitoring of influenza virus hemagglutinin in process samples using weak affinity ligands and surface plasmon resonance2008Inngår i: Analytica Chimica Acta, ISSN 0003-2670, E-ISSN 1873-4324, Vol. 623, s. 66-75Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Surface plasmon resonance (SPR) was used to screen the interaction between a variety of affinity ligands and hemagglutinin (HA) from human influenza virus, with the aim of identifying low affinity ligands useful for the development of a rapid bioanalytical sensor. Three sialic acid-based structures and four lectins were evaluated as sensor ligands. The sialic acid-based ligands included a natural sialic acid-containing glycoprotein, human α1-acid glycoprotein (α1-AGP), and two synthetic 6′-sialyllactose-conjugates, with varying degree of substitution. The interaction of HA with the four lectin-based ligands, concanavalin A (Con A), wheat germ agglutinin (WGA), Maackia amurensis lectin (MAL), and Sambucus nigra agglutinin (SNA), showed a wide variation of affinity strengths. Affinity and kinetics data were estimated. Strong affinities were observed for Con A, WGA, α1-AGP, and a 6′-sialyllactose-conjugate with a high substitution degree, and low affinities were observed for MAL and a 6′-sialyllactose-conjugate with low substitution.

    The main objective, to identify a low affinity ligand which could be used for on-line monitoring and product quantification, was met by a 6′-sialyllactose–ovalbumin conjugate that had 0.6 mol ligand per mol carrier protein. The apparent affinity of this ligand was estimated to be 1.5 ± 0.03 μM (KD) on the SPR surface. Vaccine process samples containing HA were analyzed in the range 10–100 μg HA mL−1 and correlated with single-radial immunodiffusion. The coefficient of variation on the same chip was between 0.010 and 0.091.

  • 87. Navratil, M.
    et al.
    Norberg, A.
    Lembrén, L.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    On-line multi-analyzer monitoring of biomass, glucose and acetate for growth rate control of a Vibrio cholerae fed-batch cultivation2005Inngår i: Journal of Biotechnology, ISSN 0168-1656, E-ISSN 1873-4863, Vol. 115, nr 1, s. 67-79Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    In situ near-infrared (NIR) spectroscopy and in-line electronic nose (EN) mapping were used to monitor and control a cholera-toxin producing Vibrio cholerae fed-batch cultivation carried out with a laboratory method as well as with a production method. Prediction models for biomass, glucose and acetate using NIR spectroscopy were developed based on spectral identification and partial-least squares (PLS) regression resulting in high correlation to reference data (standard errors of prediction for biomass, glucose and acetate were 0.20 g l-1, 0.26 g l-1 and 0.28 g l-1). A compensation algorithm for aerated bioreactor disturbances was integrated in the model computation, which in particular improved the prediction by the biomass model. First, the NIR data were applied together with EN in-line data selected by principal component analysis (PCA) for generating a trajectory representation of the fed-batch cultivation. A correlation between the culture progression and EN signals was demonstrated, which proved to be beneficial in monitoring the culture quality. It was shown that a deviation from a normal cultivation behavior could easily be recognized and that the trajectory was able to alarm a bacterial contamination. Second, the NIR data indicated the potential of predicting the concentration of formed cholera toxin with a model prediction error of 0.020 g l-1. Third, the on-line biomass prediction based on the NIR model was used to control the overflow metabolism acetate formation of the V. cholerae culture. The controller compared actual specific growth rate as estimated from the prediction with the critical acetate formation growth rate, and from that difference adjusted the glucose feed rate. © 2004 Elsevier B.V. All rights reserved.

  • 88.
    Navrátil, Marián
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Cimander, Christian
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    On-line multisensor monitoring of yogurt and Filmjolk fermentations on production scale2004Inngår i: Journal of Agricultural and Food Chemistry, ISSN 0021-8561, E-ISSN 1520-5118, Vol. 52, nr 3, s. 415-420Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Near-infrared (NIR) spectrometry and electronic nose (EN) data were used for on-line monitoring of yogurt and filmjölk (a Swedish yogurt-like sour milk) fermentations under industrial conditions. The NIR and EN signals were selected by evaluation of principal component analysis loading vectors and further analyzed by studying the variability of the selected principal components. First principal components for the NIR and the EN signals were used for on-line generation of a process trajectory plot visualizing the actual state of fermentation. The NIR signals were also used to set up empirical partial least-squares (PLS) models for prediction of the cultures' pH and titratable acidity (expressed as Thorner degrees, °T). By using five or six PLS factors the models yielded acceptable predictions that could be further improved by increasing the number of reliable and precise calibration data. The presented results demonstrate that the fusion of the NIR and EN signals has a potential for rapid on-line monitoring and assessment of process quality of yogurt fermentation.

  • 89.
    Ohlson, S
    et al.
    Kalmar.
    Jungar, Christina
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Strandh, M
    Kalmar.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Continuous weak-affinity immunosensing2000Inngår i: Trends in Biotechnology, ISSN 0167-7799, E-ISSN 1879-3096, Vol. 18, nr 2, s. 49-52Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    A multitude of weak biological interactions, either working alone or in concert, occur frequently throughout biological systems. We have used this natural feature of readily reversible interactions as the basis for continuous immunosensing. In a model system, a set of weak monoclonal antibodies directed towards a carbohydrate epitope was studied with the aid of surface plasmon resonance. Because the system requires no regeneration, it can be used as a truly on-line immunosensing device. This principle should have wide application in all areas where there is a need for the continuous evaluation of a molecule.

  • 90.
    Pasitka, Laura
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    van Noort, Danny
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Lim, Wanyoung
    Sungkyunkwan Univ, South Korea.
    Park, Sungsu
    Sungkyunkwan Univ, South Korea.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    A Microbore Tubing Based Spiral for Multistep Cell Fractionation2018Inngår i: Analytical Chemistry, ISSN 0003-2700, E-ISSN 1520-6882, Vol. 90, nr 21, s. 12909-12916Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Cells were separated with the aid of a multistep spiral fractionation device, utilizing hydrodynamic forces in a spiral tubing. The spiral was fabricated using "off-the-shelf microbore tubing, allowing for cheap and fast prototyping to achieve optimal cell separation. As a first step, a model system with 20 and 40 mu m beads was used to demonstrate the effectiveness of the multistep separation device. With an initial purity of 5%, a separation purity of 83% was achieved after a two-step separation with the addition of 0.1% polyethylene glycol (PEG)-8000. Next, doxorubicinresistant polyploid giant breast cancer cells (MDA-MB-231) were separated from doxorubicin-sensitive monoploid small breast cancer cells in the same fashion as the beads, resulting in a purity of around 40%, while maintaining a cell viability of more than 90%. Combined with basic cell analytical methods, the hydrodynamic separation principle of the device could be envisaged to be useful for a variety of cell fractionation needs in cell biology and in clinical applications.

  • 91.
    Paulsson, Dan
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Gustavsson, Robert
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska högskolan.
    A Soft Sensor for Bioprocess Control Based on Sequential Filtering of Metabolic Heat Signals2014Inngår i: Sensors, ISSN 1424-8220, E-ISSN 1424-8220, Vol. 14, nr 10, s. 17864-17882Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Soft sensors are the combination of robust on-line sensor signals with mathematical models for deriving additional process information. Here, we apply this principle to a microbial recombinant protein production process in a bioreactor by exploiting bio-calorimetric methodology. Temperature sensor signals from the cooling system of the bioreactor were used for estimating the metabolic heat of the microbial culture and from that the specific growth rate and active biomass concentration were derived. By applying sequential digital signal filtering, the soft sensor was made more robust for industrial practice with cultures generating low metabolic heat in environments with high noise level. The estimated specific growth rate signal obtained from the three stage sequential filter allowed controlled feeding of substrate during the fed-batch phase of the production process. The biomass and growth rate estimates from the soft sensor were also compared with an alternative sensor probe and a capacitance on-line sensor, for the same variables. The comparison showed similar or better sensitivity and lower variability for the metabolic heat soft sensor suggesting that using permanent temperature sensors of a bioreactor is a realistic and inexpensive alternative for monitoring and control. However, both alternatives are easy to implement in a soft sensor, alone or in parallel.

  • 92.
    Randek, Judit
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    On-line soft sensing in upstream bioprocessing2018Inngår i: Critical reviews in biotechnology, ISSN 0738-8551, E-ISSN 1549-7801, Vol. 38, nr 1, s. 106-121Artikkel, forskningsoversikt (Fagfellevurdert)
    Abstract [en]

    This review provides an overview and a critical discussion of novel possibilities of applying soft sensors for on-line monitoring and control of industrial bioprocesses. Focus is on bio-product formation in the upstream process but also the integration with other parts of the process is addressed. The term soft sensor is used for the combination of analytical hardware data (from sensors, analytical devices, instruments and actuators) with mathematical models that create new real-time information about the process. In particular, the review assesses these possibilities from an industrial perspective, including sensor performance, information value and production economy. The capabilities of existing analytical on-line techniques are scrutinized in view of their usefulness in soft sensor setups and in relation to typical needs in bioprocessing in general. The review concludes with specific recommendations for further development of soft sensors for the monitoring and control of upstream bioprocessing.

  • 93.
    Roch, Patricia
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    On-line monitoring of downstream bioprocesses2016Inngår i: CURRENT OPINION IN CHEMICAL ENGINEERING, ISSN 2211-3398, Vol. 14, s. 112-120Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Downstream bioprocessing can benefit significantly from using on-line monitoring methods for surveillance, control and optimisation. Timely information on critical operational and product quality parameters provided by on-line monitoring may contribute to high product quality, more efficient process operation and better production economy. Here, recent advances in analytical techniques and tools are critically reviewed and assessed based on their capability to meet typical needs and requirements in the biotechnology industry. Soft sensors, which merge the signals generated from on-line monitoring devices into mathematical models, are highlighted for accessing critical information in downstream processing.

  • 94.
    Roch, Patricia
    et al.
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Sellberg, Anton
    Lund Univ, Sweden.
    Andersson, Niklas
    Lund Univ, Sweden.
    Gunne, Matthias
    Sanofi Aventis Deutschland GmbH, Germany.
    Hauptmann, Peter
    Sanofi Aventis Deutschland GmbH, Germany.
    Nilsson, Bernt
    Lund Univ, Sweden.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi. Linköpings universitet, Tekniska fakulteten.
    Model-based monitoring of industrial reversed phase chromatography to predict insulin variants2019Inngår i: Biotechnology progress (Print), ISSN 8756-7938, E-ISSN 1520-6033, Vol. 35, nr 4, artikkel-id UNSP e2813Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Downstream processing in the manufacturing biopharmaceutical industry is a multistep process separating the desired product from process- and product-related impurities. However, removing product-related impurities, such as product variants, without compromising the product yield or prolonging the process time due to extensive quality control analytics, remains a major challenge. Here, we show how mechanistic model-based monitoring, based on analytical quality control data, can predict product variants by modeling their chromatographic separation during product polishing with reversed phase chromatography. The system was described by a kinetic dispersive model with a modified Langmuir isotherm. Solely quality control analytical data on product and product variant concentrations were used to calibrate the model. This model-based monitoring approach was developed for an insulin purification process. Industrial materials were used in the separation of insulin and two insulin variants, one eluting at the product peak front and one eluting at the product peak tail. The model, fitted to analytical data, used one component to simulate each protein, or two components when a peak displayed a shoulder. This monitoring approach allowed the prediction of the elution patterns of insulin and both insulin variants. The results indicate the potential of using model-based monitoring in downstream polishing at industrial scale to take pooling decisions.

  • 95.
    Skoglund, A.
    et al.
    Iggesunds Bruk AB.
    Brundin, A.
    Dragon Mining AB.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Applying process monitoring with multivariate analysis through a knowledge-based systems approach to a paperboard machine2005Inngår i: Computers in industry (Print), ISSN 0166-3615, E-ISSN 1872-6194, Vol. 56, nr 5, s. 472-478Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    The utility of multivariate statistical process control (MSPC) in the process industry can be further improved by applying knowledge-based systems (KBS) principles. First, the extensive volumes of process data generated in a production process can be pre-assessed by the KBS according to set rules. Second, the KBS can make a selection between various MSPC model alternatives. Third, the KBS may support the plant operators when evaluating the MSPC output results. This is shown in this preliminary study where a KBS was applied to an existing MSPC application on a paperboard machine. It is suggested that these experiences may also successfully be applied with other continuous processes in the manufacturing industry. © 2005 Published by Elsevier B.V.

  • 96. Skoglund, A.
    et al.
    Brundin, Anders
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Comparison between linear and nonlinear prediction models for monitoring of a paperboard machine2002Inngår i: Chemical Engineering & Technology, ISSN 0930-7516, E-ISSN 1521-4125, Vol. 25, nr 2, s. 197-202Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Data from a paperboard machine were used to compare the performance of linear partial least squares (PLS) and nonlinear feed-forward neural network (FFNN) modeling of a continuous process. Fifteen selected variables were used as input parameters to the models, while the quality class of the manufactured product was the output response. The models were validated with external data different to those used in the design of the models. Evaluation with root mean square error of prediction (RMSEP) showed that the FFNN models were better for prediction than the PLS models. For monitoring, however, the PLS models detected deviations from normal settings in the paperboard machine more sensitively than the FFNN models. It is suggested that these findings have general relevance to other continuous processes in manufacturing industries too.

  • 97. Skoglund, A.
    et al.
    Brundin, Anders
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Multivariate process model for grade change in a paperboard machine2000Inngår i: Nordic Pulp & Paper Research Journal, ISSN 0283-2631, E-ISSN 2000-0669, Vol. 15, nr 3, s. 183-188Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    This paper describes a practical approach to making stable multivariate models for on-line applications, which is illustrated with data from paperboard manufacturing. A partial least squares regression model was designed for two products and the grade change between them in a paperboard machine. The model was set up from historical data that covered the process from stock preparation to calendering. Validation of the model was performed with grade changes that was not in the model, which resulted in good predictions. An example is also given that describes the ability of the model to detect process disturbances.

  • 98.
    Skoglund, Anders
    et al.
    Iggesunds Paperboard AB.
    Brundin, Anders
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Monitoring a paperboard machine using multivariate statistical process control2004Inngår i: Chemometrics and Intelligent Laboratory Systems, ISSN 0169-7439, E-ISSN 1873-3239, Vol. 73Artikkel i tidsskrift (Fagfellevurdert)
  • 99.
    Skoglund, Anders
    et al.
    Iggesund Paperboard AB.
    Kessler, Waltraud
    Institut Feur Angewandte Forschung.
    Kessler, Rudolf W.
    Institut Fuer Angewandte Forschung.
    Brundin, Anders
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    On-line spectroscopic measurements of wood chips before a continuous digester2004Inngår i: Chemometrics and Intelligent Laboratory Systems, ISSN 0169-7439, E-ISSN 1873-3239, Vol. 70, s. 129-135Artikkel i tidsskrift (Fagfellevurdert)
  • 100.
    Tkac, Jan
    et al.
    Slovak Academy of Sciences.
    Vostiar, Igor
    Slovak University of Technology.
    Mandenius, Carl-Fredrik
    Linköpings universitet, Tekniska högskolan. Linköpings universitet, Institutionen för fysik, kemi och biologi, Teknisk biologi.
    Evaluation of disruption methods for the release of intracellular recombinant protein from Escherichia coli for analytical purposes2003Inngår i: Biotechnology and applied biochemistry, ISSN 0885-4513, E-ISSN 1470-8744, Vol. 40, s. 83-88Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

       

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