Program 2017

Monday October 9, 2017

15.00 — 19.00 Registration
17.00 — 18.00 Welcome reception
18.00 — 19.00 Welcome address
Keynote Lecture
Miniaturization in Process Development – HTPD at the Nano Scale
Marcel Ottens, Delft University of Technology, The Netherlands
19.00 — 20.30

Walking tour: Toledo highlights

Tuesday October 10, 2017

08.25 — 10.30 Session 1. Smart Process Development - Smart PD 
Chair; Jürgen Hubbuch, KIT, Germany
  Mechanistic Modeling of Chromatography: An Industry Perspective and Vision
Ferdinand Stückler*, Katharina Doninger, Till Briskot, Jan Griesbach, Jessica Yang, Chris Williams, Roche Diagnostics GmbH, Penzberg, Germany, Genentech Inc, South San Francisco, USA
  Mechanistic Modelling of Microscale Chromatography
Nicholas Whitelock*, Razwan Hanif . Mari Spitali , Milan Mijajlovic, Vladimir Zivkovic, Newcastle University and UCB Pharma
  Rapid, Integrated Product Development of Industrial Enzymes at DuPont
Luis G. Cascão-Pereira*, Jim Kellis, Josh Basler, DuPont Industrial Biosciences, USA
  Modified Batch Isotherm Determination Method for Mechanistic Model Calibration
Tobias Hahn*(1,2), Thiemo Huuk(1,2), Jürgen Hubbuch(2),
1) GoSilico GmbH, Karlsruhe, Germany
2) Karlsruhe Institute of Technology (KIT), Karlsruhe, Germany
10.30 — 11.00 Coffee break
11.00 — 13.05 Session 2Case studies Upstream
Chair; Jonathan Coffman, Boehringer Ingelheim, USA 
  Scale Down Model Qualification of Ambr250 High-throughput Mini-bioreactor System for Two Commercial Scale MAb Processes
Matthew Manahan*, Michael Nelson, Jessica Weng, Jonathon Cacciatore, Sen Xu, Jennifer Pollard
Merck Sharp & Dohme Corp., Kenilworth, NJ USA
  Reducing Cell Line Development Timelines through Next Generation Automation using Nanofluidics
Tanner Nevill, Troy Lionberger, Keith Breinlinger*
Berkeley Lights, Emeryville, CA USA
  How High Throughput Cell Culture Automation Benefits Upstream Process Development
Carsten Musmann
Roche Diagnostics GmbH, Penzberg, Germany
  Enabling High-throughput Microbial Fermentation
Sandra Abad*, Nils Janzen, Daniela Reinisch
Boehringer-Ingelheim, Vienna, Austria
16.00 — 19.00. Poster session

Wednesday October 11, 2017

08.25 — 10.35 Session 3Case studies Downstream Part I; Chromatography
Chair; Jennifer Pollard, Merck, USA
  Understanding Robocolumn Scale Offsets and Exploring the Use of Robocolumns as a Scale Down Model
Michael Chinn*, John Lazzareschi, Jerry Bill, Ben Tran
Genentech, South San Francisco, CA USA
  Overcoming Challenges for Qualifying Miniature Columns as a Scale-down Model
John Welsh*, Steve Benner, Michael Rauscher, Nihal Tugcu, David Roush, Jennifer Pollard
Merck Sharp & Dohme Corp., Kenilworth, NJ USA
  Towards Efficient Chromatographic Processes for Complex Biological Feedstocks
Silvia M. Pirrung1*, Luuk A.M. van der Wielen1, Ruud F.W.C. van Beckhoven2, Michel H.M. Eppink3, Marcel Ottens1
1) Delft University of Technology, Delft, The Netherlands 2) DSM Biotechnology Center, Delft, The Netherlands 3) Synthon Biopharmaceuticals B.V., Nijmegen, The Netherlands
  Integration of Downstream Platform Development into a Single 96-well Filter Plate for Ultra-rapid Process Definition
Ron Gillespie*, Jeremy Shaver, Megan McClure, Lisa Connell-Crowley, Scott Freeman Just Biotherapeutics, Seattle, WA USA
  Adapting Existing HTPD Tools to Suit Rapid Development of Bespoke Affinity Resins
Warren Kett Avitide Inc., Lebanon, NH USA
11.05 — 13.10 Session 4Case studies Downstream Part II; Other techniques
Chair; 
Ashley Hesslein, Bayer Healthcare, USA
 

Optimizing Clarification and Capture to Support High-throughput Cell Culture Process Development
Steven Traylor*, Kathleen Trejo, Rachel Yang, Joseph Calzada, Joanne Rivera, Greg Barker, Jongchan Lee, Zheng Jian Li,
Bristol-Myers Squibb, Devens, MA USA

  Integrated Process Development: Case Studies for High Quality Analysis of Upstream Screenings
Cornelia Walther1*, Simon Haidinger1, Dario Boras1, Sophie Fröhlich1, Astrid Dürauer2, Cecile Brocard1
1) Boehringer-Ingelheim, Vienna, Austria
2) University of Natural Resources and Life Sciences, Vienna, Austria
  High Throughput Strategies for Ultrafiltration Process Development
Jennifer Pollard*, Ehsan Borujeni, Inkwan Han, Nihal Tugcu 
Merck Sharp & Dohme Corp., Kenilworth, NJ USA
  Downstream Process Development of Novel Antibody Formats
Thomas von Hirschheydt
Roche Innovation Center Munich, Penzberg, Germany
13.10 Lunch Break
15.55 — 18.35 Session 5: Case studies DS Modifications and DP Formulations 
ChairAaron Noyes, Codiak BioSciences, Melrose, MA, USA
  High Throughput Tangential Flow Filtration for Formulation Robustness
Anthony Portolesi*, Zephania Kwong Glover, Debbie O’Connor, William Man, John Lazzareschi, Judy Hsii, John Betts
Genentech, South San Francisco, CA USA and Sartorius-Stedim, UK
  Progress and Challenges in High Throughput Stability Screening at Genentech
David Smithson*, Jia Sun, Katherine Tschudi, Yilma Adem, Bill Galush
Genentech Inc., South San Francisco, CA USA
  Sophisticated Screening Approach to Characterize Complex Therapeutic Proteins
Nicole Weiner1*, Daniel Maurer1, Kai Baumgartner2, Frank Hämmerling2, Michael Allmer1
1) Boehringer Ingelheim RCV, Vienna, Austria
2) Boehringer Ingelheim Pharm, Biberach, Germany
  Establishing a High-throughput Process Development Platform for an Antibody Conjugation Process
Sebastian Andris1*, Michaela Wendeler2, Jürgen Hubbuch1
1) Karlsruhe Institute of Technology, Karlsruhe, Germany
2) MedImmune LLC, Gaithersburg, PA USA
  Enabling High-throughput Methods for Gene Therapy Products
Yige Wu1, Samriti Bedi2, Logan Trimble1, Michael Shifrin1, Vimal Vaidya1, Joseph Barberio3, Stephen Dicker1, Michael Kuczewski*4
1) Vector Downstream Process Development; 2) Vector Analytical Development; 3) mRNA Process Development 4) Manufacturing Science & Technology, bluebird bio, Cambridge, MA USA
19.30 — 22.30 Conference Dinner – Hacienda del Cardenal, Toledo

Thursday October 12, 2017

08.55 — 11.30 Session 6: Frontiers in Process Development 
Chair; Stefan Hepbildikler, Roche Diagnostics, Penzberg, Germany
  Process Development in the Digital Biomanufacturing Age
William Whitford1*, Daniel Horbelt2
1) GE Healthcare, Logan, UT USA 2) Insilico Biotechnology A, Stuttgart, Germany
  Entry-level 3D (Bio-)printing for LHS-based High-throughput Experimentation
Carsten P. Radtke*, Nils Hillebrandt, Jurgen Hubbuch
Karlsruhe Institute of Technology, Karlsruhe, Germany
  Applications of Directly Scalable Protein A Chromatography for High Throughput Process Development
Ian Scanlon, Chris Morris, Matt Townsend, Oliver Hardick*
Puridify, Stevenage, UK
  A Microfluidic Approach for Rapid Screening of Chromatography Operating Conditions: Multiplexed Optimization of Different Target Molecules
Inês F. Pinto1,2*, D.R. Santos1,2, R.R.G. Soares1,2, M.R. Aires-Barros2,3, V. Chu1, J.P. Conde1,3, A.M. Azevedo2,3
1) INESC Microsystems and Nanotechnologies and IN – Institute of Nanoscience and Nanotechnology, Lisbon, Portugal
2) IBB – Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Lisbon, Portugal
3) Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Lisbon, Portugal
11.30 — 12.00 Closing remarks
Phil Lester