Presentations 2019

Monday 4 November 2019

Join a preconference day to quickly get up to speed with different aspects of HTPD, smart PD, as well as mechanistic modelling. The preconference day is especially useful if you are new to the field, have just started to use HTPD tools, or need a refresher on some of the basics. The preconference day is organized by GE and is only available for registered attendants of the HTPD conference. It is optional and comes without any additional charge.

PRE-CONFERENCE WORKSHOP

1. PD evolution
Peter Hagwall, GE Healthcare

2. HTPD Upstream tools and when to use them
Andreas Castan, GE Healthcare

3. Downstream tools and when to use them
Eggert Brekkan, GE Healthcare

4. From HT screening to production with straight-through model-based process development
Tobias Hahn, GoSilico

5. Merck’s HTPD journey—from beginner to advanced user
Jennifer Pollard, Merck

6. Fast Trak Case studies and available resources
Charlotte Brink, GE Healthcare

Keynote lecture: In Silico Facilitated Downstream Process Development”
Speaker: Professor Steven Cramer, Rensselaer Polytechnic Institute , USA

Tuesday 5 November 2019
SESSION 1. SMART PROCESS DEVELOPMENT - SMART PD

101 From sequence to process - in silico DSP development based on quantitative structure-property relationships
David Saleh(,1,2), Michelle Ahlers-Hesse(1), Federico Rischawy(3), Gang Wang(1), Simon Kluters(1), Joey Studts(1), Jürgen Hubbuch(2)
1: Late Stage DSP Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany 2: Karlsruhe Institute of Technology (KIT), Institute of Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe, Germany 3: Early Stage Bioprocess Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

102 Using High Throughput Screening and Data Management Solutions to Enable Mechanistic Modeling of Chromatography Processes
Michael Chinn, Jessica Yang, Derek Lee, Bella Del Hierro, Kenny Huynh
Genentech, South San Francisco, CA, USA

103 Mechanistic identification of CEX elution conditions for an antibody aggregate separation using Kp screening
Tobias Hahn¹*, David Saleh²³, Nora Geng¹, Simon Kluters², Jürgen Hubbuch³
¹ GoSilico GmbH, Karlsruhe, Germany ² Late Stage DSP Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany ³ Karlsruhe Institute of Technology (KIT), Institute of Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe, Germany

104. Application of integrated process modelling and machine learning techniques in high-throughput process development
Cornelia Walther et al
Boehringer-Ingelheim RCV, Vienna, Austria

105 Mechanistic modelling - the ultimate HTPD tool?
Gunnar Malmquist* Peter Hagwall
GE Healthcare, Uppsala, Sweden

Focus Lecture
Organizing and managing heterogenous and big data from the brain: Human Brain Project brain atlas infrastructure
Professor Jan Bjaalie, University of Oslo, Norway

SESSION 2. CASE STUDIES - MONOCLONAL ANTIBODIES AND ANTIBODY-LIKE MOLECULES
Session chair: John Welch, Merck & Co, USA

201 An AKTA™, an autosampler and a Fibre: A different approach to rapid high throughput purification of proteins.
Jennifer Spooner*, Ian Scanlon, Penny Hamlyn, Niel Williams
AstraZeneca Cambridge UK. GE Healthcare Life Sciences Stevenage UK, Teledyne CETAC Technologies Omaha Nebraska

202 A Microfluidic high-throughput platform to debottleneck dowsntream process development
André Nascimento, Mariana S. Pedro, Inês F. Pinto, Maria Raquel Aires-Barros, Ana .M. Azevedo
iBB – Institute For Bioengineering And Biosciences, Instituto Superior Técnico - Lisbon, Portugal

203 Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond
Brian Murray*1, Tridevi Dahal-Busfield1, Arjun Bhadouria1, Martina Fischer2, and Kevin Brower1
1Sanofi Genzyme, Framingham, MA, USA, 2Sanofi, Frankfurt am Main, Germany

204 Using the ambr® crossflow system, a UF/DF high throughput screening tool, to predict pilot-scale TFF performance during monoclonal antibody processing
Lara Fernandez-Cerezo* Michael K Wismer Inkwan Han Jennifer Pollard
Merck & Co., Inc, Kenilworth (NJ, USA)

205 Peering Through the Crystal Ball - Predicting Drug Product Stability at Genentech
David Smithson*, Jonathan Zarzar, Saeed Izadi, Jia Sun, Kate Tschudi, Sam Burns, Cleo Salisbury, Nisana Andersen
Genentech, Inc, South San Francisco, USA

SESSION 3. CASE STUDIES INTEGRATED PD AND ANALYTICS
Jonathan Coffman, AstraZeneca, USA

301 HTPD, an integration story: The path to fully automate bioreactor development, robo-column purification and measure product quality attributes for all process development bioreactors
Kelcy Newell,* Tom Albanetti, Robert Heckathorn, Rod Brian Jimenez, Ken Lee, Rohan Patel, Andrew Smith, Kevin D. Stewart, Jeremy Springall
AstraZeneca, Gaithersburg, MD

302 High Throughput Online Monitoring of Biological Respiration Activities in Single Wells of 96-Deepwell Microtiterplates
Robert Dinger *, Clemens Lattermann, David Flitsch, Jochen Büchs
Dinger R.: AVT - Biochemical Engineering, RWTH Aachen University, Aachen, Germany Büchs J.: AVT - Biochemical Engineering, RWTH Aachen University, Aachen, Germany Lattermann C.: Kuhner Shaker GmbH, Herzogenrath, Germany, Flitsch D. PyroScience GmbH, Aachen, Germany

303 High-Throughput Screening of Cell Substrates for an Oncolytic Virus to Accelerate Process Development
Chris Daniels*, Ryan Katz, Murphy Poplyk, Marc Wenger
MSD Research Laboratories, West Point, PA, USA

304 The Dynamic Development of High Throughput Data and Systems for Ever-Evolving Science
Michal Maciejewski, Idris Mustafa, Edward Kraft, Yvonne Franke, Lee Lior-Hoffmann*
Genentech, South San Francisco, USA

SESSION 4. CASE STUDIES - NOVEL BIOMOLECULES
Session chair: Jack Kramarczyk, Moderna Therapeutics, USA

401 Automated High throughput Chromatography Screening Platform for Virus Purification
Sheng-Ching Wang*, Spyridon Konstantinidis, Marc D. Wenger
Vaccines Process Development, MRL, MSD, West Point, PA, USA

402 Development of a High-Throughput Agitated Scale Down Model for CAR-T Process Development
Guy Caspary
Juno Therapeutics, a Celgene Company Seattle, US

403 Exosomes are complex, HTPD doesn't have to be
Michael F. Doherty, Andrew Wood, Bryan Choi, Aaron Noyes
Codiak BioSciences, Cambridge, MA, USA

404 Ambr®250 HT System: A Key Process Development Tool for New Live Virus and Microbial Vaccine Candidates
Jessica Olson*, Greeshma Manomohan, Alyssa Brown, Christopher Lee, Samantha Moyer, Marc Wenger
Vaccines Process Development, MSD, West Point, PA, USA

405 High-throughput process development of an ion exchange chromatography step for primary capture of lentiviral vector
Vimal H. Vaidya*, Lauren Graham, Matt Lesher, Stephen Dicker
bluebird bio, Cambridge, MA, USA.

406 Selection and development of analytical tools to enable agile viral vector process development
Chelsea Amstuz, Ivan Brown, Tyler Kennedy, Angela Lam, Thuy Nguyen, Tim Sakanashi, Eric Stevens, Julia Proctor, Benjamin Tillotson, Michele Murphy, Eric Mauser, Richa Tyagi, Laura DeMaster, Kumud R. Poudel, Elena Peletskaya, John Moscariello, and Brenna Kelley-Clarke*
Juno Therapeutics, a Celgene company, Seattle, WA, USA

Session 5. HTPD/Smart PD panel discussion
Session chair: Ashley Hesslein, Bayer HealthCare, USA

Session 6. Frontiers in HTPD/Smart PD
Session chair: Stefan Hepbildikler, Roche, Germany

601 High-throughput Process Development in Precision Medicine: Engineering and Scale Out of a Personalized mRNA Cancer Vaccine
Chris Ladd*, Jason Murphy, Nedim Emil Altaras, Juan Andres
Moderna Therapeutics

602 QbD and smartPD join forces. Understanding the interplay between resin variability and process parameters
Peter Hagwall* and Gunnar Malmquist
GE Healthcare Lifesciences, Uppsala, Sweden

603 Enabling technology through high throughput techniques
Brian Taylor
Zymergen

604 Modelling approaches with a fully-automated microbial fermentation platform
Joseph Newton*,1, Annina Sawatzki1, Vignesh Rajamanickam1,2, Jeannine Gesson1, Stefan Haider1, Sandra Abad1, Daniela Reinisch1
1 Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria 2 Institute of Chemical Engineering, Technische Universität Wien, Vienna, Austria

605 Modeling chromatography without doing chromatography: Is it possible?
Steven W. Benner, John P. Welsh, Jennifer M. Pollard
Merck & Co., Inc., Kenilworth, NJ, USA