Preliminary program

Monday 9 October 2017
15:00 - 19:00
Registration
17:00 - 18:00
Welcome reception
18:00 - 19:00
Keynote lecture

Miniaturization in Process Development – HTPD at the Nano Scale

Marcel Ottens, Delft University of Technology, The Netherlands
19:00 - 20:30
Toledo highlights. Walking tour
Juan Jose' Espadas, Info Tur Network, Spain
Tuesday 10 October 2017
Session 1. Smart Process Development - Smart PD
Chair: Jürgen Hubbuch, KIT, Germany
08:30 - 09:00
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

09:00 - 09:30
Mechanistic Modelling of Microscale Chromatography

Nicholas Whitelock*, Razwan Hanif . Mari Spitali , Milan Mijajlovic, Vladimir Zivkovic, Newcastle University and UCB Pharma

09:30 - 10:00
Rapid, Integrated Product Development of Industrial Enzymes at DuPont

Luis G. Cascão-Pereira*, Jim Kellis, Josh Basler, DuPont Industrial Biosciences, USA

10:00 - 10:30
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), Institute of Process Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe, Germany

10:30 - 11:00
Coffee break
Session 2. Case studies Upstream
Chair: Jonathan Coffman, Boehringer Ingelheim, USA
11:00 - 11:30
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, Process Development and Engineering, Biologics & Vaccines, Merck Sharp & Dohme Corp., Kenilworth, NJ USA

11:30 - 12:00
Reducing Cell Line Development Timelines through Next Generation Automation using Nanofluidics

Tanner Nevill*, Troy Lionberger, Keith Breinlinger, Berkeley Lights, Emeryville, CA US

12:00 - 12:30
How High Throughput Cell Culture Automation Benefits Upstream Process Development

Carsten Musmann, Roche Diagnostics GmbH, Penzberg, Germany

12:30 - 13:00
Enabling High-throughput Microbial Fermentation

Sandra Abad(1)* , Nils Janzen (2) , Daniela Reinisch (1), (1) Boehringer-Ingelheim Regional Center Vienna, Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria, (2) Department of Biotechnology, University of Natural Resources and Life Sciences Vienna, Muthgasse 18, 1190 Vienna, Austria

13:00 - 16:00
Lunch break
16:00 - 19:00
Poster Session and refreshments
Wednesday 11 October 2017
Session 3. Case studies Downstream Part I; Chromatography
Chair: Jennifer Pollard, Merck, USA
08:30 - 08:55
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, USA

08:55 - 09:20
Overcoming Challenges for Qualifying Miniature Columns as a Scale-down Model

John Welsh*, Steve Benner, Michael Rauscher, Nihal Tugcu, David Roush, Jennifer Pollard, MSD, Kenilworth, NJ, USA

09:20 - 09:45
Towards Efficient Chromatographic Processes for Complex Biological Feedstocks

Silvia M. Pirrung (1)*, Luuk A.M. van der Wielen (1), Ruud F.W.C. Van Beckhoven (2), Michel H.M. Eppink (3), Marcel Ottens (1), (1) Delft University of Technology, Delft, The Netherlands (2) DSM Biotechnology Center, Delft, The Netherlands (3) Synthon Biopharmaceuticals B.V., Nijmegen, The Netherlands

09:45 - 10:10
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 Washington, USA

10:10 - 10:35
Adapting Existing HTPD Tools to Suit Rapid Development of Bespoke Affinity Resins

 Warren Kett, Avitide Inc., Lebanon NH, USA

10:35 - 11:00
Coffee break
Session 4. Case studies Downstream Part II; Other techniques
Chair: Ashley Hesslein, Bayer HealthCare, USA
11:00 - 11:30
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

11:30 - 12:00
Integrated Process Development: Case Studies for High Quality Analysis of Upstream Screenings

Cornelia Walther(1)*, Simon Haidinger(1), Dario Boras(1), Sophie Fröhlich(1), Astrid Dürauer(2), Cecile Brocard(1)
(1) Boehringer-Ingelheim RCV, Vienna, Austria, (2) University of Natural Resources and Life Sciences Vienna, Vienna, Austria

12:00 - 12:30
High Throughput Strategies for Ultrafiltration Process Development

Jennifer Pollard*, Ehsan Borujeni, Inkwan Han, Nihal Tugcu
Merck & Co., Kenilworth, NJ, USA

12:30 - 13:00
Downstream Process Development of Novel Antibody Formats

Thomas von Hirschheydt
Roche Innovation Center Munich, Penzberg, Germany

13:00 - 16:00
Lunch break
Session 5. Case studies DS Modifications and DP Formulations
Chair: Aaron Noyes, Codiak BioSciences, USA
16:00 - 16:25
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 and Sartorius-Stedim, UK

16:25 - 16:50
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, USA

16:50 - 17:20
Coffee break
17:20 - 17:45
Sophisticated Screening Approach to Characterize Complex Therapeutic Proteins

Nicole Weiner (1)*, Daniel Maurer (1), Kai Baumgartner (2), Frank Haemmerling (2), Michael Allmer(1), (1) Boehringer Ingelheim RCV GmbH & Co. KG; Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria (2) Boehringer Ingelheim Pharma GmbH & Co. KG, Pharmaceutical Development BP, 88397 Biberach, Germany

17:45 - 18:10
Establishing a High-throughput Process Development Platform for an Antibody Conjugation Process

Sebastian Andris*, Michaela Wendeler, Jürgen Hubbuch, Sebastian Andris, Jürgen Hubbuch: Institute of Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe Institute of Technology, Karlsruhe, Germany Michaela Wendeler: Department of Purification Process Sciences, MedImmune LLC, Gaithersburg, USA

18:10 - 18:35
Enabling High-throughput Methods for Gene Therapy Products

Yige Wu(1), Samriti Bedi(2), Logan Trimble(1), Michael Shifrin(1), Vimal Vaidya(1), Joseph Barberio(3), Stephen Dicker(1), Michael Kuczewski(4)*, (1) Vector Downstream Process Development, bluebird bio (2) Vector Analytical Development, bluebird bio (3) mRNA Process Development, bluebird bio (4) Manufacturing Science & Technology, bluebird bio, 60 Binney St., Cambridge, MA 02142

19:30 - 22:30
Conference Dinner
Thursday 12 October 2017
Session 6. Frontiers in Process Development
Chair: Stefan Hepbildikler, Roche, Germany
09:00 - 09:30
Process Development in the Digital Biomanufacturing Age

William Whitford (1)*, Daniel Horbelt(2), (1) GE Healthcare, (2) Insilico Biotechnology AG

09:30 - 10:00
Entry-level 3D (Bio-)printing for LHS-based High-throughput Experimentation

Carsten P. Radtke*, Nils Hillebrandt, Jürgen Hubbuch, Karlsruhe Institute of Technology, Institute of Engineering in Life Sciences Section IV: Biomolecular Separation Engineering, Karlsruhe, Germany

10:00 - 10:30
Coffee break
10:30 - 11:00
Applications of Directly Scalable Protein A Chromatography for High Throughput Process Development

Ian Scanlon, Chris Morris, Matt Townsend, Oliver Hardick*
Puridify, Stevenage Bioscience Catalyst, Gunnels Wood Rd, Stevenage, UK

11:00 - 11:30
A Microfluidic Approach for Rapid Screening of Chromatography Operating Conditions: Multiplexed Optimization of Different Target Molecules

Inês F. Pinto (1,2)*, D.R. Santos (1,2), R.R.G. Soares (1,2), M.R. Aires-Barros (2,3), V. Chu (1), J.P. Conde (1,3), A.M. Azevedo (2,3), (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