HTPD 2014 Programme


Monday October 6, 2014

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

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
  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
  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
  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
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
  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
  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
  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
  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
17.45 — 19.45 Poster session

Wednesday October 8, 2014

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, 2) BioSilta Europe GmbH, Berlin, Germany, 3) PreSens Precision Sensing GmbH, Regensburg, Germany, 4) infoteam Software AG, Bubenreuth, Germany, 5) Technische Universität Berlin, Chair of Measurement and Control, Berlin, Germany, 6) Organobalance GmbH, Berlin, Germany,
  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
  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
  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
  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
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
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.
  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
  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
  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
  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
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

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
  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.
  Understanding the Chromatography Behavior of Monoclonal Antibodies Using Quantitative Structure-Property Relationship Analysis
Benjamin Tran*, Brian Connolly, Tom Patapoff, Paul McDonald
Genentech, Inc., USA
  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
  Evaluation of different HIC ligand densities — Updating the chromatography toolbox through collaborative efforts
William Holmes
Eli Lilly and Company, USA
  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
11.30 — 12.00 Conference ends