Biotechnology Journal

Cover image for Vol. 7 Issue 10

Special Issue: High-throughput process development

October 2012

Volume 7, Issue 10

Pages 1185–1316, A1–A8

  1. Cover Picture

    1. Top of page
    2. Cover Picture
    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
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      High-throughput process development (page 1185)

      Version of Record online: 5 OCT 2012 | DOI: 10.1002/biot.201290050

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      Special issue: High-throughput process development.

      High-throughput process development (HTPD) combines high-throughput experimentation, adequate analytical methods and advanced experimental design and/or data analysis. This Special issue is edited by Jürgen Hubbuch (Karlsruhe Institute of Technology, KIT, Karlsruhe, Germany). Cover image by Florian Dismer und Stefan Oelmeier showing a robot pipetting in 96-well format.

  2. Editorial Board

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    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
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      Editorial Board: Biotechnology Journal 10/2012

      Version of Record online: 5 OCT 2012 | DOI: 10.1002/biot.201290054

  3. Editorial

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    4. Editorial
    5. In this issue
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    7. BiotecVisions
    8. Forum
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      Editorial: High-throughput process development (page 1185)

      Prof. Jürgen Hubbuch

      Version of Record online: 5 OCT 2012 | DOI: 10.1002/biot.201200333

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      During the last decade we saw a dramatic change on how process development is performed in industry. The enabling tool box behind this change is summarized in the terminology High-throughput process development (HTPD). HTPD combines high-throughput experimentation, adequate analytical methods and advanced experimental design and/or data analysis, which is presented in this special issue.

  4. In this issue

    1. Top of page
    2. Cover Picture
    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
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      In this issue (page 1186)

      Version of Record online: 5 OCT 2012 | DOI: 10.1002/biot.201290051

  5. Contents

    1. Top of page
    2. Cover Picture
    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
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  6. BiotecVisions

    1. Top of page
    2. Cover Picture
    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
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  7. Forum

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    7. BiotecVisions
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    10. Technical Report
    11. Research Articles
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    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
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  8. Research Articles

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    4. Editorial
    5. In this issue
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    7. BiotecVisions
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    9. Research Articles
    10. Technical Report
    11. Research Articles
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    1. High-throughput process development of chromatography steps: Advantages and limitations of different formats used (pages 1192–1202)

      Dr. Karol M. Łącki

      Version of Record online: 25 JUL 2012 | DOI: 10.1002/biot.201100475

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      Intrinsic features of formats used in high-throughput process development (HTPD) studies of chromatography steps can influence results. Theoretical analysis of the mass transfer rate limiting step during adsorption of proteins on different types of chromatography resins reveal that effects related to different hydrodynamic conditions occurring when different HTPD formats are used can lead to systematic deviation from results obtained at relevant scale. These effects can be minimized by choosing a right format for the screening studies based on a the proposed high throughput format maps.

    2. Examination of a genetic algorithm for the application in high-throughput downstream process development (pages 1203–1215)

      Katrin Treier, Annette Berg, Patrick Diederich, Katharina Lang, Anna Osberghaus, Florian Dismer and Dr. Jürgen Hubbuch

      Version of Record online: 30 JUL 2012 | DOI: 10.1002/biot.201200145

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      Application of high-throughput experiments combined with optimization methods can be used to speed up downstream process development. In contrast to Design of Experiments in combination with response surface analysis, Genetic Algorithms (GAs) can be applied to identify optimal parameter settings in multidimensional optimizations tasks. In this study, the authors conducted a systematic study to set up GA runs in terms of initial population design, population size, selection pressure and the choice of an objective function. As to be expected, the optimal parameter combination is a function of the experimental space and the complexity of the optimization task. This could be incorporated in this study by generating ‘experimental data’ in silico using different mathematical functions.

  9. Technical Report

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    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
    1. Predicting protein dynamic binding capacity from batch adsorption tests (pages 1216–1220)

      Prof. Giorgio Carta

      Version of Record online: 14 JUN 2012 | DOI: 10.1002/biot.201200136

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      The dynamic binding capacity (DBC) and its dependence on residence time influence the design and productivity of adsorption columns used in protein capture applications. In this study, the author introduces a very simple approach to predict the DBC of an adsorption column based on a measurement of the equilibrium binding capacity (EBC) and of the time needed to achieve one-half of the EBC in a batch adsorption test. The same approach is also shown to be applicable for other system where solute transport inside the particle occurs through other transport mechanisms.

  10. Research Articles

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    11. Research Articles
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    14. Perspective
    15. Meetings and Conferences
    1. Model-based high-throughput process development for chromatographic whey proteins separation (pages 1221–1232)

      Beckley K. Nfor, Jovana Ripić, Albert van der Padt, Marc Jacobs and Dr. Marcel Ottens

      Version of Record online: 5 SEP 2012 | DOI: 10.1002/biot.201200191

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      Application of high-throughput (HT) experimentation and process modeling in downstream process development: A robotic liquid-handling platform was used for HT resin screening and measurment of protein isotherms. Isotherm parameters were then regressed and the purification unit operation models experimentally validated, model-optimized and rationally evaluated based on their optimized performances. The selected best process was then scaled-up in silico. By this approach, a much wider space of operating variables could be optimized than possible experimentally.

    2. Studying host cell protein interactions with monoclonal antibodies using high throughput protein A chromatography (pages 1233–1241)

      Vikram N. Sisodiya, Joshua Lequieu, Maricel Rodriguez, Paul McDonald and Kathlyn P. Lazzareschi

      Version of Record online: 22 JUN 2012 | DOI: 10.1002/biot.201100479

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      Protein A chromatography is typically used as the initial capture step in the purification of monoclonal antibodies. Although exploiting an affinity interaction for purification, the level of host cell proteins in the protein A eluent varies significantly with different feedstocks. Using a high throughput batch binding method in conjunction with a library of monoclonal antibodies, the authors demonstrate that although the levels of host cell proteins in the protein A eluent can be influenced by the type of protein A resin, antibody-host cell protein interactions are primarily responsible for the variable levels of host cell proteins following protein A chromatography.

    3. Applying high-throughput methods to develop a purification process for a highly glycosylated protein (pages 1242–1255)

      Dr. Nooshafarin Sanaie, Douglas Cecchini and John Pieracci

      Version of Record online: 24 SEP 2012 | DOI: 10.1002/biot.201200170

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      Micro-scale chromatography formats are becoming more routinely used in purification process development because of their ability to rapidly screen large number of process conditions at a time with minimal material. This work provides a case study for high-throughput screening of cation exchange (CEX) and hydrophobic interaction (HIC) chromatography conditions in a 96-well filter plate format for a purification process designed to alter the glycoform distribution of a small protein.

    4. Strategic Assay Selection for analytics in high-throughput process development: Case studies for downstream processing of monoclonal antibodies (pages 1256–1268)

      Spyridon Konstantinidis, Simyee Kong, Sunil Chhatre, Ajoy Velayudhan, Eva Heldin and Prof. Nigel Titchener-Hooker

      Version of Record online: 24 SEP 2012 | DOI: 10.1002/biot.201100476

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      In high-throughput process development studies a large number of conditions are typically tested for multiple analytes. This creates an analytical bottleneck and can delay process investigation activities. This article introduces Strategic Assay Selection, which addresses the bottleneck by systematically identifying those analytics that satisfy best user defined criteria and thus enable the efficient completion of high-throughput studies.

  11. Technical Report

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    10. Technical Report
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    15. Meetings and Conferences
    1. Self-packed filter plates: A good alternative for pre-packed filter plates for developing purification processes for therapeutic proteins (pages 1269–1276)

      Xiaonan Li, Guy de Roo, Kim Burgers, Marcel Ottens and Dr. Michel Eppink

      Version of Record online: 24 SEP 2012 | DOI: 10.1002/biot.201200045

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      This article presents experimental evidence that the use of self-packing filter plates in the purification process development of therapeutic proteins is a good alternative for pre-packed filter plates. A thorough study shows that not only the selection of the right self-packed filter plates but also pipetting the right amount of resin in the 96-wells is feasible to control the resin content in each well.

  12. Research Articles

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    7. BiotecVisions
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    14. Perspective
    15. Meetings and Conferences
    1. Comparative reaction engineering studies for succinic acid production from sucrose by metabolically engineered Escherichia coli in fed-batch-operated stirred tank bioreactors (pages 1277–1287)

      Torben Hoefel, Georg Faust, Liv Reinecke, Nicolas Rudinger and Prof. Dirk Weuster-Botz

      Version of Record online: 14 JUN 2012 | DOI: 10.1002/biot.201200046

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      Intensive research has been carried out about succinic acid for the application as chemical building block derived from renewable resources. In this work a comparative reaction engineering study of 16 recombinant E. coli strains genetically modified for the production of succinic acid from sucrose was performed in fed-batch operated milliliter-scale stirred tank bioreactors. The results demonstrate the importance of parallel approaches within the scope of applied metabolic engineering studies.

    2. Monitoring ceramic hydroxyapatite media degradation using dynamic image analysis and uniaxial confined bulk compression (pages 1288–1296)

      Dr. Oliver Kaltenbrunner, Shawn Cao, Esteban Freydell, Nick Keener, Li Zhu, Nancy Jiao, Brian Williamson, Mark A. Snyder and Larry J. Cummings

      Version of Record online: 6 JUN 2012 | DOI: 10.1002/biot.201100481

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      Particle strength of Ceramic Hydroxyapatite (CHT) can be monitored by Dynamic Image Analysis (DIA): Poor buffer selection causes damage to resin particles and reduced packed bed lifetime. DIA can visualize this damage and these results correlate with mechanical particle strength. The method described in this work can be used to monitor resin damage during development and to optimize the buffer system for maximum packed column bed lifetime.

    3. A revisited folding reporter for quantitative assay of protein misfolding and aggregation in mammalian cells (pages 1297–1307)

      Simpson Gregoire and Dr. Inchan Kwon

      Version of Record online: 27 JUN 2012 | DOI: 10.1002/biot.201200103

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      Protein misfolding and aggregation play important roles in many physiological processes. In this study, the authors revisit a folding reporter green fluorescent protein (GFP) system in mammalian cells, which was originally developed for bacterial cells. GFP was fused to the C-terminus of a panel of human copper/zinc superoxide dismutase (SOD1) mutants with varying misfolding/aggregation propensities The developed assay will facilitate the understanding of aggregation process of SOD1 variants and the identification of aggregation inhibitors. The method also has great promise for misfolding/aggregation studies of other proteins in mammalian cells.

  13. Perspective

    1. Top of page
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    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences
    1. Monitoring and control of microbioreactors: An expert opinion on development needs (pages 1308–1314)

      Krist V. Gernaey, Frank Baganz, Ezequiel Franco-Lara, Frank Kensy, Ulrich Krühne, Marc Luebberstedt, Uwe Marx, Eva Palmqvist, Andreas Schmid, Frank Schubert and Prof. Carl-Fredrik Mandenius

      Version of Record online: 11 SEP 2012 | DOI: 10.1002/biot.201200157

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      Microbioreactors are new useful tools for bioprocess development and in vitro toxicity testing. In this perspective article an expert panel (the M3C Working Group of the European Section of Biochemical Engineering Science, ESBES, in the European Federation of Biotechnology, EFB) discusses how microbioreactors can be improved by using advanced measurement, monitoring and control methods. It concludes with a set of recommendations for extended use and further development of microbioreactors.

  14. Meetings and Conferences

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    2. Cover Picture
    3. Editorial Board
    4. Editorial
    5. In this issue
    6. Contents
    7. BiotecVisions
    8. Forum
    9. Research Articles
    10. Technical Report
    11. Research Articles
    12. Technical Report
    13. Research Articles
    14. Perspective
    15. Meetings and Conferences

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