HTPD 2014 Programme
Monday October 6, 2014 |
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| 13.00 — 19.00 | Registration |
| 15.00 — 18.00 | Workshop: Lessons learned in building HTPD capabilities |
| 18.00 — 19.00 | Welcome reception |
| 19.00 — 19.15 | Welcome address |
| 19.15 — 20.00 | Plenary lecture;Perspectives of HTPD techniques for modelling and QbD Implementation Speaker: Arne Staby, Ph.D. Fellow, Sr. Principal Scientist, Adj. Professor Novo Nordisk A/S, Denmark |
Tuesday October 7, 2014 |
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| 08.00 — 11.00 | Session 1: Modeling and data analysis Chair; S. Hepbildikler, Roche |
| HTPD Support with a Data Acquisition Management and Analysis Software (DAMAS) at Roche Georg Pollinger Roche Diagnostics GmbH |
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| Hybridized experimental and algorithmic analysis of complex chromatographic separations Alexander T. Hanke*(1), Peter D.E.M. Verhaert(1), Luuk A.M. van der Wielen(1), Emile J.A.X van de Sandt(2), Michel H.M. Eppink(3) and Marcel Ottens(1) (1) TU Delft - Department of Biotechnology, Delft, The Netherlands, (2) DSM Biotechnology Center, Delft, The Netherlands (3) Synthon Biopharmaceuticals B.V., Nijmegen, The Netherlands |
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| Use of high-throughput data in whole-bioprocess modelling S. Konstantinidis, N. Field, K. Jurlewicz, and A. Velayudhan* Department of Biochemical Engineering, University College London, UK |
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| Rapid process development with UV absorption based inverse modelling of protein chromatography Tobias Hahn*, Pascal Baumann, Thiemo Huuk, Jürgen Hubbuch Karlsruhe Institute of Technology (KIT), Institute of Process Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe, Germany |
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| 11.00 — 15.00 | Lunch and networking opportunities |
| 15.00 — 17.45 | Session 2: Case studies I: Downstream Chair; T. Linden, Merck Co & Inc |
| Catching up bioprocess development on the downstream side Cornelia Walther*(1), Matthias Berkemeyer(2), Astrid Dürauer(1) (1)University of Natural Resources and Life Sciences, Vienna, Austria, (2)Boehringer-Ingelheim RCV |
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| High Throughput Platform to Accelerate the Development of Particle Conditioning Operations for Biologics Aaron Noyes*, Ben Huffman, Alex Berrill, Nick Merchant, Ranga Godavarti, Nigel Titchener-Hooker, Khurram Sunasara, Tarit Mukhopadhyay Pfizer BioTherapeutics Pharmaceutical Sciences, 1 Burtt Road, Andover, MA 01810, USA Department of Biochemical Engineering, University College London, Bernard Katz Building, Gordon Street, London, WC1E 7JE, UK Pfizer BioTherapeutics Pharmaceutical Sciences, 700 Chesterfield Parkway, Chesterfield, MO 63017, USA Pfizer Vaccine Research Unit, 401 N. Middletown Rd. Pearl River, NY 10965, USA |
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| Modified Batch Chromatography, Isotherm, and Batch Uptake Workflows for Enhanced Process Design Space Screening Gregory Barker*, Joseph Calzada, Zheng Ouyang, Sibylle Herzer, Siegfried Rieble Bristol-Myers Squibb, Biologics Process Development, Hopewell, NJ, USA |
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| Faster development of flocculation recipes and prediction of the cake resistance in a High-throughput set-up M.W. Wilson, S. Beurskens, E. Freydell, G.N.M. Ferreira, A.M.C. Janse, E.J.A.X. van de Sandt, M.R. Sahoo* DSM Biotechnology Center, Dep. Downstream Processing, A. Fleminglaan 1, 2613 AX, Delft, The Netherlands |
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| Utilizing high throughput techniques to evaluate next generation multimodal chromatography resins John Welsh(1), Eggert Brekkan(2), Haiying Bao(1), Ken Barlow(1), Francis Insaidoo(1), Karol Lacki(2), David Roush(1) (1)Merck & Co., Inc., Bioprocess Development, Kenilworth, NJ, USA (2)GE Healthcare Life Sciences, Uppsala, Sweden |
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| 17.45 — 19.45 | Poster session |
Wednesday October 8, 2014 |
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| 08.00 — 11.00 | Session 3: Case studies II: Upstreams Chair; J. Coffman, Boehringer Ingelheim |
| Automated development of recombinant bioprocesses "from vision to mission" A. Knepper(1,*), F. Glauche(1), L. Theuer(1), M. Heiser(1), F. Wollny(1), S. Bigesse(1,2), A. Neubauer(2), S. Arain(3), G. T. John(3), J. Aschoff(4), B. Stehlik(4), I. Schmid(4), N. Violet(5), R. King(5), D. Goelling(6), A Raab(6), G. Kiesewetter(1,6), R. Nolte(1,6), P. Neubauer(1) 1) Technische Universität Berlin, Chair of Bioprocess Engineering, Berlin, Germany, www.bioprocess.tu-berlin.de 2) BioSilta Europe GmbH, Berlin, Germany, www.biosilta.com 3) PreSens Precision Sensing GmbH, Regensburg, Germany, www.presens.de 4) infoteam Software AG, Bubenreuth, Germany, www.infoteam.de 5) Technische Universität Berlin, Chair of Measurement and Control, Berlin, Germany, www.mrt.tu-berlin.de 6) Organobalance GmbH, Berlin, Germany, www.organobalance.de |
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| Downstream Process Development for Mammalian Cells: High-Throughput Screening of Cell Partitioning in Aqueous Two-Phase Systems Sarah Zimmermann*, Sarah Gretzinger, Anna Osberghaus, Jürgen Hubbuch Institute of Process Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe, Germany |
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| Design and Commissioning of a Biosafety Level-2 High-Throughput Screening Platform for Process Development of Viral Vaccine Production Chris Daniels*, Esther Lim, Jason Rodriguez, Marc Wenger Merck Research Laboratories, West Point, PA, USA |
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| Glutathione-S-Transferase from Escherichia coli: high-throughput micro-scale cultivations and chromatography modeling as powerful tools for integrated process development Pascal Baumann*, Tobias Hahn, Nicolai Bluthardt, Anna Osberghaus, Jürgen Hubbuch Karlsruhe Institute of Technology (KIT), Biomolecular Separation Engineering, Karlsruhe, Germany |
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| Non-invasive measurement using chemical-optical sensors as a tool for High Throughput Bioprocess Development: Applications in microbial and cell culture Gernot T. John*(1), Christian Krause(1), Ina Dittler(2), Regine Eibl(2), Dieter Eibl(2) (1)PreSens Precision Sensing GmbH, Regensburg, Germany (2)Zürich University of Applied Sciences, Wädenswil, Switzerland |
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| 11.00 — 12.30 | Networking opportunities |
| 12.30 — 15.00 | Session 4: Case studies III: Formulations Chair; A. Velayudhan, UCL |
| Development of a High-Throughput Screening Platform to Study the Adsorption of Antigens onto Aluminum-containing Adjuvants Vanessa Jully*(1,2), Nicolas Moniotte(2), Frédéric Mathot(2), Dominique Lemoine(2) & Véronique Préat(1) 1)Université Catholique de Louvain, Louvain Drug Research Institute, Pharmaceutics and Drug Delivery, Avenue Mounier, 73 B1.73.12, 1200 Brussels, Belgium. 2) GlaxoSmithKline Vaccines, Vaccine Discovery and Development, New Product Development, Rue de l'Institut 89, 1330 Rixensart, Belgium. |
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| Approaches to high-throughput monitoring of antibody oxidation for process characterization studies: regional, peptide and site-specific John W Eschelbach*, Jennifer Hu, Lisa Vampola, Amy Hildebrand Protein Analytical Chemistry, Genentech Inc., South San Francisco, CA USA |
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| Transforming high-throughput biophysical data into manufacturability indices for high-concentration antibody formulations Suzanne S. Farid*(1),Yang Yang2, Ajoy Velayudhan(1), Nina F. Thornhill(2) 1) Department of Biochemical Engineering, University College London, Gordon Street, London WC1H OAH, UK 2) Department of Chemical Engineering, Imperial College London, South Kensington Campus, London SW7 2AZ, UK |
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| High throughput screening of protein refolding and the utilization of UPLC and NMR analysis in the optimization of drug product candidates Brian OMara*, Luciano Mueller, Nicole Payonk, Matthew Conover, Reb Russell, Siegfried Rieble Bristol-Myers Squibb |
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| High Throughput Approaches in Formulation Development — Successes and Lessons Learned at Genentech, Inc. David C. Smithson*, Kevin Ng, Jia Sun, Brian Connoly, Kathryn Wang, Stefan Yohe and Martha Lovato Tse Pharmaceutical Development, Genentech Inc., South San Francisco, CA USA |
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| 15.00 — 15.30 | Coffee Break |
| 15.30 — 18.00 | Session 5: HTPD Olympiad Chair; Philip Lester, Genentech Inc., USA /Karol Lacki, GE Healthcare, Sweden |
| "Participating teams present their performed work and results" | |
| 19.00 — 22.00 | Conference dinner |
Thursday October 9, 2014 |
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| 08.30 — 11.30 | Session 6: HTPD 2020 Chair; Jürgen Hubbuch, KIT |
| High Throughput Strategies for the Development of Viral Vaccine Processes Marc Wenger*, Sianny Christanti, Chris Daniels, Kevin Huff, Jess Olson, Sheng-ching Wang Merck & Co., Inc, USA |
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| Multiproduct HTS for Simultaneous Product Selection and Process Development Jack F. Kramarczyk*, Michael F. Doherty, Vimal H. Vaidya, Kathryn R. Heard, Subhayu Basu, Ying-Ja Chen, Michael J. Hamill Pronutria, Inc. |
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| Understanding the Chromatography Behavior of Monoclonal Antibodies Using Quantitative Structure-Property Relationship Analysis Benjamin Tran*, Brian Connolly, Tom Patapoff, Paul McDonald Genentech, Inc., USA |
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| The Need for Speed. Leveraging High Throughput Technology to Accelerate the Time to Clinic Sethu Siva, Alexis Henry, Edward Koepf*, Lynn Conley, and Doug Cecchini Biogen Idec |
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| Evaluation of different HIC ligand densities — Updating the chromatography toolbox through collaborative efforts William Holmes Eli Lilly and Company, USA |
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| Robo-characterization: Can miniature columns predict a manufacturing future? J. Pollard*, H. Bao, M. Petroff, S. Kandula, N. Tugcu, J. Welsh, T. Linden Process Development and Engineering, Bioprocess Development, Merck Research Laboratories, Kenilworth, NJ USA |
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| 11.30 — 12.00 | Conference ends |