September 23-26, 2018
Snowbird Resort
Snowbird, Utah

Editors:   Weibing Ding, Amgen
  Martina Micheletti, University College London
  Robert Repetto, Pfizer

The articles for these proceedings are not peer-reviewed.

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Conference Program, Weibing Ding, Martina Micheletti, and Robert Repetto (Article)

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Process intensification in biomanufacturing driven by advances in single use technologies, Stefan Schmidt (Abstract and Presentation)

A deep dive into the process of designing and developing a single-use aseptic connector, Todd Andrews (Abstract)

Speed up biopharma devices’ release to market, Nelly Montenay and Nazli Gulsine Ozdemir (Abstract)

Use of SUS for non-conventional synthetic manufacturing platforms, Anuradha Vaidya, Bill Scott, and Dave Kolwyck (Abstract)

Polymer hydrogels: A biocompatible material with multiple potential uses in single-use sensors, Jules Magda (Abstract)

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pH evolution in solution after contact with multilayer films after different g- irradiation doses and thus reconciliation of pH and TOC with carboxylic acids detected by ion chromatography, Samuel Dorey, Fanny Gaston, Nathalie Dupuy, Magali Barbaroux, and Sylvain R.A. Marque (Abstract and Presentation)

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Automated foam control in single-use bioreactors using the single use foam probe, Jordan Cobia, Ben Madsen, Emilee Madsen, and Alex Hodge (Abstract and Presentation)

Responsive hydrogel sensor for monitoring antibody production, Nicholas Frazier, Seunghei Cho, Yoonsung Goo, Prashant Tathireddy, Rohit Sharma, and Jules J. Magda (Abstract)

Probing for solutions: Evaluating new pH sensors for upstream single-use applications, Nick Rummel and Arthi Narayanan (Abstract)

Data analytics and soft sensors for single use bioprocessing, Patrick Sagmeister and Christoph Herwig (Abstract)

Pilot scale implementation of a single-use, high intensity, integrated process system, Robert Kottmeier, John Galyas, Phil McCormick, Michael O’Connor, and David Sullivan (Abstract)

Continuous bioprocessing in single-use bioreactors: Beyond stirred tank- based solutions, Stefan Junne, Peter Neubauer, and Nico Oosterhuis (Abstract)

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Continuous Process Performance Enhancements for 50-500 L S.U.B.s, Ben Madsen, Jordan Cobia, Nephi Jones, and Kevin Mullen (Abstract and Presentation)

Low-footprint, intensified, single-use platform for the production of viral vaccines, Alex Chatel (Abstract)

Understanding the science behind the liquid leak and microbial ingress mechanisms as the foundation for single-use container closure integrity (SU-CCI), Marc Hogreve, Carole Langlois, and Jean-Marc Cappia (Abstract)

Automated approaches to process development and manufacture of human T-cells and mesenchymal stem cells using single-use bioreactor technologies, Qasim Rafiq (Abstract)

Engineering scalable manufacturing of high-quality human MSC for cell therapy: From up to downstream processing integration to cell proteome characterization, Margarida Serra, Sofia B. Carvalho, Marta M. Silva, Ricardo A. Gomes, Bárbara Cunha, Tiago Aguiar, Manuel J. T. Carrondo, Patrícia Gomes-Alves, Cristina Peixoto, and Paula M. Alves (Abstract)

Creating commercial opportunities for regenerative medicine by introducing closed, automated solutions with single-use principles, Matthew Marsh, Alex Klarer, and David Smith (Abstract)

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Polymer interfaces and biopharmaceuticals: Chemistry, designs and challenges, David W. Grainger (Abstract and Presentation)

Single-use equipment for handling and manufacturing of highly potent APIs, Diego Schmidhalter (Abstract)

Particulate contamination in single-use systems: real versus perceived risk, Klaus Wormuth, Magali Barbaroux, Nelly Montenay, Mathieu Labedan, and Melanie Gauthier (Abstract)

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Comparison of single-use and steel fermenters for KLa and aggressive microbial cultures, Jason Brown, Christopher Brau, and Nephi Jones (Abstract and Presentation)

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Single-use and sustainability: Continued studies using LCA tools, William Whitford (Abstract and Presentation)

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Purity testing protocols for silicone tubing, Csilla Kollar and Lise Tan-Sien-Hee (Abstract and Presentation)

Embedded particles in single-use films: Cosmetic defect or integrity risk?, Klaus Wormuth, Nelly Montenay, and Lucie Delaunay (Abstract)

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TuFlux TPE tubing for pharma processing, Pradnya Parulekar and Michael Drechsel (Abstract and Presentation)

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The proper use of extractables data - aspects beyond extractables-measurment, Samuel Dorey, Armin Hauk, Roberto Menzel, Thomas Loewe, and Ina Pahl (Abstract and Presentation)

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Qualification of low drift single-use pH sensors for use in single-use bioreactor platforms, Jason Brown, Alexander J. Hodge, and Nephi Jones (Abstract and Presentation)

Single use shake flasks with integrated sensors as easy to use bioprocessing tool, Gernot John and Christian Ude (Abstract)

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Mixing Operations for 50 L to 2000 L Single-Use Mixer: Liquid-Liquid Mixing Characterization and Slurry Suspension, Jordan Cobia, Kevin Mullen, and Becky Staerk (Abstract and Presentation)

Study of accuracy and selectivity of a hydrogel-based sensor array by Design of Experiments (DOE), Prashant Tathireddy, Rohit Sharma, Nick Frazier, Seung Hei Cho, Yoonsung Goo, Derik West, and Jules J. Magda (Abstract)

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Single-Use pH sensor via a coplanar pH glass electrode design, CD Feng and Robert Garrahy (Abstract and Presentation)

Extractables and leachables in continuous processing system, Benben Song (Abstract)

Single use plastic settlers for clarifying cell culture broth, selective removal of dead cells and affinity capture of antibodies on protein A beads, Dhinakar Kompala, Mark Harris, Christopher Glascock, and Premsingh Samuel (Abstract)

Optimization of the single use bioreactor for growth and bead-to-bead transfer of Vero cells cultured on microcarriers, Ben Madsen, Paula Decaria, Nephi Jones, Tony Hsiao, and Alex Hodge (Abstract)

Scalable, high performance single-use technology to meet gene therapy production demands, Alex Chatel (Abstract)

Manufacturing human mesenchymal stem cells at clinical scale: Process and regulatory challenges, Dieter Eibl, Valentin Jossen, Regine Eibl, and Christian van den Bos (Abstract)

Bioprocessing and engineering characterisation of T-cell therapy manufacture in an ambr® 250 bioreactor, Qasim Rafiq, Elena Costariol, and Marco Rotondi (Abstract)

Sterile media hold scale-up using MOBIUS® single-use technology, Adam Sokolnicki, Kara Fouhy, and Adam Sokolnicki (Abstract)

Engineering scalable manufacturing of high-quality human MSC for cell therapy: From up to downstream processing integration to cell proteome characterization, Margarida Serra, Tiago Aguiar, Sofia B. Carvalho, Marta M. Silva, Ricardo A. Gomes, Manuel J. T. Carrondo, Patrícia Gomes-Alves, Cristina Peixoto, Paula M. Alves, and Bárbara Cunha (Abstract)

Is it ever too early to close and/or automate manufacturing of cell therapies?, Matthew Marsh and David Smith (Abstract)

Harvesting exosomes for therapeutic applications, Mikhail Skliar (Abstract)

Case study: Leveraging automation and custom single-use systems to streamline media production and enable scalability for CAR-T manufacturing, Takeshi Nishiura, Randy Schweickart, and Jon Gunther (Abstract)

Process development for increased MSC production in single use stirred tank bioreactors, Tiffany Hood (Abstract)

Improved DynaBead removal using designed-for-purpose BioProcess containers, Jordan Cobia, Tony Hsiao, Lars Norderhang, Nephi Jones, and Tor Espen (Abstract)

Growth behavior of human adipose tissue-derived stromal/stem cells in single-use spinner flasks: Numerical and experimental investigations, Valentin Jossen, Regine Eibl, Dieter Eibl, and Matthias Kraume (Abstract)

Study on mixing and fluid dynamics in single-use shaken systems, Yi Li, Martina Micheletti, and Andrea Ducci (Abstract)

Adaptive combination of SSB and SUB equipment to master complexity in clinical manufacturing in the clinical supply center, Christian Beck, Christoph T.A. Meiringer, and Alexander P.O. Herrmann (Abstract)

Comparison of alternative single use harvest technologies for large scale harvests of mammalian cell culture processes, Daniel Bock (Abstract)

New approach for qualifying liquid handling in single-use bags, Frederic Bazin and Elisabeth Vachette (Abstract)

Understanding the functional limits of single use components through pressure testing, Michael Goodwin and Jon Schultz (Abstract)

Small volume single use facility strategy - Harvest case study, Katherine Fong, Gabriella del Hierro, and Arthi Narayanan (Abstract)

Use of the Ambr 250 to enable rapid clone selection and process development for large scale manufacturing processes, Martina Micheletti, Colleen Clark, Gary Lye, Gabi Tremml, and Anurag Khetan (Abstract)

Closed system approach to cell expansion, Michael Zumbrum (Abstract)

Transitioning to facility using Single Use Technology (SUT), Karthik Veeravalli, Vinson Tan, Ganesh Vissvesvaran, Asiedua Asante, and Ralph Von Daeniken (Abstract)

How to develop health-promoting food supplements by using single-use bioreactors, Philipp Jakob Meier, David Schildberger, Dieter Eibl, Tilo Hühn, and Regine Eibl (Abstract)

Manufacturing single use systems with quality in mind: How to assure performance, robustness, and sterility of single use systems, Kara Fouhy, Sara Bell, and Jon Sarno (Abstract)

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An example of thermoset – Silicone, Csilla Kollar (Abstract and Presentation)