Biotechnology Journal

Cover image for Vol. 7 Issue 12

Special Issue: Biopharmaceuticals

December 2012

Volume 7, Issue 12

Pages 1421–1531, A1–A8

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    8. BiotecVisions
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    11. Mini-Review
    12. Reviews
    13. Research Article
    14. Technical Reports
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    16. Meetings
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      Cover Picture: Biotechnology Journal 12/2012

      Version of Record online: 5 DEC 2012 | DOI: 10.1002/biot.201290060

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      Special issue Biopharmaceuticals. Drug discovery and production are highly interlinked, because the main product attributes need to be defined early on. This Special issue edited by Alois Jungbauer (University of Natural Resources and Life Sciences, Vienna, Austria) and Klaus Graumann (Sandoz GmbH, Kundl, Austria) covers several areas relevant to the discovery, development and manufacturing of biopharmaceuticals. Topics include antibodies, protein engineering and purification.

      Images: Antibodies © Elena Pankova – Fotolia.com; Biopharmaceutical Production © Sandoz.

  2. Cover Gallery

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      Biotechnology Journal 2012 Cover Gallery

      Version of Record online: 5 DEC 2012 | DOI: 10.1002/biot.201290064

  3. Editorial Board

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  4. Editorial

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      Editorial: Biopharmaceuticals – discovery, development and manufacturing (pages 1422–1423)

      Prof. Alois Jungbauer and Dr. Klaus Graumann

      Version of Record online: 5 DEC 2012 | DOI: 10.1002/biot.201200360

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      This Special issue, Biopharmaceuticals – discovery, development and manufacturing is edited by Alois Jungbauer and Klaus Graumann and includes articles on various aspects of the development of biopharmaceuticals. Topics covered include the importance of antigen presentation in creating and selecting binding molecules, G-protein-coupled receptors as drug targets, and continuous downstream processing.

  5. In this issue

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    4. Editorial Board
    5. Editorial
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    14. Technical Reports
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      In this issue (page 1424)

      Version of Record online: 5 DEC 2012 | DOI: 10.1002/biot.201290061

  6. Contents

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  7. BiotecVisions

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  8. Forum

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      Meeting report: 15th Annual Conference of the European BioSafety Association 2012 (pages 1427–1428)

      Dr. Benedictus J.M. Verduin

      Version of Record online: 5 DEC 2012 | DOI: 10.1002/biot.201200302

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      This year's annual meeting of the European BioSafety Association, the 15th of the series, took place on June 12–13, 2012 in Manchester, United Kingdom. Dr. Benedictus Verduin (BioRiskManagement, Wageningen, The Netherlands), President of EBSA 2007–2008, reports the proceedings of the meeting in this concise forum article.

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      Stanley N. Cohen – An interview (page 1430)

      Judy Peng

      Version of Record online: 9 NOV 2012 | DOI: 10.1002/biot.201200359

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      Biotechnology Journal talks to Prof. Stanley Cohen after his plenary lecture at the International Biotechnology Symposium, Sept 2012, in Daegu, Korea.

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      Book review: Biomechatronic Design in Biotechnology – A methodology for Development of Biotechnological Products (pages 1431–1432)

      Felix Lenk

      Version of Record online: 1 NOV 2012 | DOI: 10.1002/biot.201200245

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      Biomechatronic Design in Biotechnology, by Carl-Fredrik Mandenius and Mats Björkman, aims to link aspects of biotechnology with mechanical and electrical engineering. Read this book review by Felix Lenk to find out more about this book.

  9. Review

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    1. Antigen generation and display in therapeutic antibody drug discovery – a neglected but critical player (pages 1433–1443)

      Dr. Hilmar Ebersbach and Sabine Geisse

      Version of Record online: 9 NOV 2012 | DOI: 10.1002/biot.201200066

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      The quality of antigens, independent of its mode of presentation, influences the outcome of an antibody generation process. A diligent selection of the expression system and the related antigen format is similarly important as an optimized purification method and analytical confirmation of the nature of the sample. This review summarizes the most important aspects of antigen generation and display, enabling sensible decision making in order to give rise to potent high-affinity antibodies.

  10. Mini-Review

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    1. Current strategies in antibody engineering: Fc engineering and pH-dependent antigen binding, bispecific antibodies and antibody drug conjugates (pages 1444–1450)

      Dr. Karen J. Vincent and Mauro Zurini

      Version of Record online: 1 NOV 2012 | DOI: 10.1002/biot.201200250

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      Antibody engineering technologies are constantly advancing in order to improve the clinical effectiveness of monoclonal antibodies. This review covers current antibody engineering strategies for the modification of therapeutic antibodies in the areas of Fc and pH-dependent antigen binding, bispecific antibodies and antibody drug conjugates

  11. Reviews

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    1. Structure-function studies with G protein-coupled receptors as a paradigm for improving drug discovery and development of therapeutics (pages 1451–1461)

      Patrick M. McNeely, Andrea N. Naranjo and Prof. Anne S. Robinson

      Version of Record online: 9 NOV 2012 | DOI: 10.1002/biot.201200076

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      Better therapies through targeting receptor interaction sites. Modern therapeutic design often leads to side effects, and the complexity of the signaling pathways involved requires a holistic view of how a new drug may interact with the organism as a whole. This article reviews experimental techniques to examine G protein-coupled receptor signal modulation (e.g. through ligands, protein interactions, or membrane interactions) in vivo and in vitro as a means of more precisely targeting these receptors for therapies while minimizing side effects.

    2. The sweet tooth of biopharmaceuticals: Importance of recombinant protein glycosylation analysis (pages 1462–1472)

      Nico Lingg, Peiqing Zhang, Zhiwei Song and Dr. Muriel Bardor

      Version of Record online: 25 JUL 2012 | DOI: 10.1002/biot.201200078

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      Glycosylation is a critical quality attribute of biopharmaceutical drugs. This review examines the functional importance of glycosylation in the context of recombinant biopharmaceuticals produced in eukaryotic systems, as well as current analytical methods. It is intended to provide a framework for designing the quality target glycoforms of recombinant glycoproteins and planning a workflow for glycan analysis.

    3. Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins (pages 1473–1484)

      Dr. Miranda M. C. van Beers and Dr. Muriel Bardor

      Version of Record online: 2 OCT 2012 | DOI: 10.1002/biot.201200065

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      A major challenge for bringing biopharmaceuticals to the market is minimizing the formation of anti-drug antibodies. To improve safety and efficacy of biopharmaceuticals, the critical quality attributes of proteins that affect immunogenicity need to be controlled. This review discusses the impact of protein structure, glycosylation, chemical modification and aggregation on immunogenicity in the current context of quality by design (QbD).

    4. Multimodal chromatography: An efficient tool in downstream processing of proteins (pages 1485–1495)

      Kristian Kallberg, Hans-Olof Johansson and Leif Bulow

      Version of Record online: 9 NOV 2012 | DOI: 10.1002/biot.201200074

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      Multimodal chromatography, in which hydrophobic interactions in combination with pH-dependent electrostatic forces are used, are employed in more and more in bioseparations today. A variety of ligands have been designed and explored both in situ and in silico, for example in descriptor modeling or in ligand docking studies. In this review the authors give an overview of the available ligands, some recent developments and how modeling has been used for a better understanding of the involved interactions.

  12. Research Article

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    1. Periodic counter-current chromatography – design and operational considerations for integrated and continuous purification of proteins (pages 1496–1508)

      Dr. Rahul Godawat, Kevin Brower, Sujit Jain, Konstantin Konstantinov, Frank Riske and Veena Warikoo

      Version of Record online: 9 NOV 2012 | DOI: 10.1002/biot.201200068

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      Designing integrated and continuous purification and its advantages. This study demonstrates a practical, theoretical approach for the design of a continuous chromatography step using periodic counter current chromatography. A generic approach is developed based on the protein breakthrough curve and can be applied to most protein-chromatographic resin systems. The integrated and continuous mode of operation simultaneously achieves increased throughput and improved resin capacity utilization, typically unattainable in traditional batch processing.

  13. Technical Reports

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    1. Endotoxin removal and prevention for pre-clinical biologics production (pages 1509–1516)

      Dr. Anne Serdakowski London, Brendan Kerins, William R. Tschantz and Kasey Mackay

      Version of Record online: 9 NOV 2012 | DOI: 10.1002/biot.201200220

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      Endotoxin is removable and preventable in a non-GMP setting. This article presents findings that showcase a variety of approaches for minimizing endotoxin contents in pre-clinical protein preparations. Chromatography methods, membrane and filter technologies, and preventative washes are compared and best practices for an engineer's toolbox are suggested to remove endotoxin in a variety of scenarios.

      Corrected by:

      Correction: Corrigendum to: Endotoxin removal and prevention for pre-clinical biologics production

      Vol. 8, Issue 8, 957, Version of Record online: 2 AUG 2013

    2. A high-throughput assay for enzymatic polyester hydrolysis activity by fluorimetric detection (pages 1517–1521)

      Ren Wei, Thorsten Oeser, Susan Billig and Prof. Dr. Wolfgang Zimmermann

      Version of Record online: 27 JUN 2012 | DOI: 10.1002/biot.201200119

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      The enzymatic hydrolysis of polyethylene terephthalate (PET) can be determined by a fluorimetric assay. Terephthalate released enzymatically from PET is quantified following its conversion to the fluorescent 2-hydroxyterephthalate by an iron autoxidation-mediated generation of free hydroxyl radicals. The assay is robust at different buffer concentrations, reaction times, pH values, and in the presence of proteins. In a 96-well microplate format, the method can be applied for the high-throughput screening of polyester hydrolases.

  14. Perspective

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    1. How can measurement, monitoring, modeling and control advance cell culture in industrial biotechnology? (pages 1522–1529)

      Manuel J. T. Carrondo, Paula M. Alves, Nuno Carinhas, Jarka Glassey, Friedemann Hesse, Otto-Wilhelm Merten, Martina Micheletti, Thomas Noll, Rui Oliveira, Udo Reichl, Arne Staby, Ana P. Teixeira, Henry Weichert and Prof. Carl-Fredrik Mandenius

      Version of Record online: 5 SEP 2012 | DOI: 10.1002/biot.201200226

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      The potential of measurement, monitoring, modeling and control (M3C) methodologies in animal and human cell culture technology is highlighted by an expert panel of biotechnologists and biochemical engineers with both academic and industrial backgrounds. The latest ascents in M3C are discussed from a cell culture perspective for industrial process development and production needs. The report provides a set of recommendations for targeting M3C research towards the industrial interests.

  15. Meetings

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