October 18-21, 2015 - Lansdowne Resort, Leesburg, VA, USA

Editors:   Ekta Mahajan, Genentech, Inc., USA
  Gary Lye, University College London, UK

The articles for these proceedings are not peer-reviewed.

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Final Program, Ekta Mahajan and Gary Lye (Conference Proceeding)

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Approach to biomaterials selection using a risk-based approach, Patricia Rafidison (Conference Proceeding)

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Thermodynamics of migration in polymers: Can contamination from materials in contact be predicted, controlled and possibly avoided?, Olivier Vitrac and Phuong Nguyen (Conference Proceeding)

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The Effects of Irradiation Technologies on Some Polymers commonly used in SUDs, Olivier Vrain (Article)

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Polyolefins and their influence on single use technology for bioprocessing, Amy Plancon and Marnik Vaes (Conference Proceeding)

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Overview of the links between material properties and film extrusion process, Ralf Reiser, Stefan Jendrosch, and Ingo Schnellenbach (Conference Proceeding)

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Headache be gone: Clearance of extractables and leachables in single-use technologies through ultrafiltration/diafiltration, Kate Lee, Nicholas Magarian, Kunal Nagpal, Ekta Mahajan, and Kenneth Skidmore (Conference Proceeding)

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Limitation and detection of bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) from bioprocess container materials, Samuel Dorey, Ina Pahl, Isabelle Uettwiller, Sebastien Janvier, and Elke Jurkiewicz (Conference Proceeding)

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Silicone tubing extractables and their relationship to particulates, Csilla Kollar (Conference Proceeding)

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Application of BPOG standardized extractables protocol to container films: The impact of different sample conditions and analytical procedures on E&L profile, Mohamad Awada (Conference Proceeding)

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Impact of a toxic single-use bio-process container film leachable on Chinese hamster ovary cells, Heather Nunn and Matthew Hammond (Conference Proceeding)

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Wakey wakey sleepyhead- A case study in adapting single use bioreactors to a sensitive cell line, Ganesh Prasadh Vissvesvaran (Conference Proceeding)

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Case study: Identification, characterization and mitigation of growth inhibitory leachable compound from disposable plastic vessels, Zara Melkounian (Conference Proceeding)

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Characterizing changes in protein quality attributes to assess leachable risks from single-use bioprocess containers, Nina Xiao, Colin Medley, Ian Shieh, Gregory Downing, Ankit Patel, Shelly Pizarro, and Jun Liu (Conference Proceeding)

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Single use sensors: Sensing a need for change, David Pollard (Conference Proceeding)

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Preventing Leaks in a Single Use System, Trishna Ray-Chaudhuri (Conference Proceeding)

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Flexural fatigue behavior of rocking bioreactor films, Donald Buckley, K. Amanda Misner, Terry Saunders, Andrew Burns, Hongyi Zhou, Eugene Boden, Susan Burke, Ross Acucena, and Mark Roberts (Conference Proceeding)

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Sensors for continuous monitoring of disposable bioreactors, Kenneth Reardon (Conference Proceeding)

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Container Closure Integrity (CCI) for single-use systems (SUS): Regulatory trends, challenges and technology transfer of test methods, Carole Langlois and Marc Horeve (Conference Proceeding)

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Large scale freeze-thaw bag system for protein bulk storage: Prototypes development, Phillippe Lam (Article)

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Single use polymeric materials: The science of safety, Mitchell Cheeseman (Conference Proceeding)

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Applying practices from the medical device industry to ensure patient safety of single-use products in the biotechnology industry, Jan Oberdoerster (Conference Proceeding)

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Homogenizing biologic drug substance bulk using single use mixing systems, Benson Gikanga, Yufei Chen, Oliver Stauch, and Yuh-Fun Maa (Conference Proceeding)

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Single-use bioreactor technologies for early stage development of microalgae cultivation processes, Gary Lye, Ebenezer Ojo, Hadiza Auta, and Frank Baganz (Conference Proceeding)

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Interchangeability of SUS - Functional specification and materials of construction, Chris Smalley (Conference Proceeding)

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Challenges and status: Single-use bioreactors for microbial processes, Peter Neubauer, Anna Maria Marba Ardebol, Friederike Hillig, Olivia Zakrzewski, Jorn Emmerich, N.M.G. Ooosterhuis, and S. Junne (Conference Proceeding)

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Successfully employing single-use bioreactors for different expression systems, Valentin Jossen, Regine Eibl, and Dieter Eibl (Conference Proceeding)

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What's in The Bag?, Rebecca Olsen, Diane Hahm, and Jing Li (Conference Proceeding)

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Material science enabled quality by design: The new standard in SUS development, Christian Julien (Conference Proceeding)

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Conversion of polymers – properties and processing, Phillip Jordan (Conference Proceeding)

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AComDim applied to evaluate gamma irradiation impact on multilayer PE based films, Fanny Gaston, Sylvain Marque, Nathalie Dupuy, and Samuel Dorey (Conference Proceeding)

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Static vs. dynamic extraction – Comparing best practice for Single Use Technology, Paul Killian, Ven A. Raman, Jessica Shea, and Mae Santos-Rosa (Conference Proceeding)

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Single-use bag extractable case study: Lessons learned, Jayanthi Grebin and Mike Johnson (Conference Proceeding)

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Monitoring clearance of extractables and leachables from Single-Use Technologies by NMR, Nicholas Margarian, Kate Lee, Kunal Nagpal, and Ken Skidmore (Conference Proceeding)

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Hazard and risk assessments for impurities, residual solvents, extractables, and leachables., Jan Oberdoerster (Conference Proceeding)

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The practical application of BPOG E&L protocols to viral clearance filters, Paul Killian, Thomas Stone, and Jessica Shea (Conference Proceeding)

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Adopting a fully single-use process to improve speed to clinic: A leachables case study, Jessica Shea, Elizabeth Goodrich, Ross Acucena, Paul Killian, and Janmeet Anant (Conference Proceeding)

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Challenges of scale down model for disposable bioreactors: Case studies on growth & product quality impacts, Jincai Li, Guangming Zhang, and Huilin Zhu (Conference Proceeding)

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Assessing cell lines for cell growth assays as alternative for existing cytotoxicity assays, Eike Jurkiewicz and Alexander Tappe (Conference Proceeding)

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An approach to evaluate new Single-Use film types, Katharina Blasckczok, Lidija Lisica, and Regine Eibl (Conference Proceeding)

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Identification of antioxidant by-products based on their specific chemistry and their potential detection during SUS extractable study, Samuel Dorey, Fanny Gaston, Nathalie Dupuy, Sylvain Marque, and Gerard Audran (Conference Proceeding)

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An Investigational Study on The Impact of An Incopatible Filtration Of Benzyl Alcohol Using a Polyethersulfone Membrane, Michael DiFiore (Conference Proceeding)

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Engineering characterisation of a rocked-bag bioreactor to evaluate key effectors of successful mammalian cell culture, Douglas Marsh, Matthew Osborne, Martina Micheletti, and Gary Lye (Conference Proceeding)

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Single Use bioreactors: Geometry does matter, Colin Jaques and Anthony Beaney (Conference Proceeding)

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Appraisal of the mixing performance of Single-Use shaken bioreactors, Gregorio Rodriguez, Tibor Anderlei, Andrea Ducci, and Martina Micheleti (Conference Proceeding)

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Single-use capacitance measurement of cell viability, Dan Kopec, Stuart Tindal, Marcus Weise, Sven GroB, Henry Weichert, Thomas Schnitzler, Manfred Biselli, and Mario Becker (Conference Proceeding)

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Single-Use bioprocess containers: Raw material control strategy for optimal cell growth, Susan Burke, Sara Ullsten, Eva Blanck, Eva Lindskog, Shujian YI, Jeffrey Carter, Pokon Ganguli, and Herman Parma (Conference Proceeding)

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Implementation and characterization of solvent detergent viral inactivation in Single Use bags, MIchael Cunningham, Ven Raman, Nitin Sood, Jessica Shea, Lori Mullin, Eric Youssef, Pedro Almeida, and Elizabeth Goodrich (Conference Proceeding)

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Integration considerations for replacing stainless steel tanks with Single-Use mixers, Hana Sheikh (Conference Proceeding)

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Cell culture scale translation from a 24-well Single-Use miniature bioreactor and subsequent impact on product and broth quality, John Betts, Franc Baganz, Gary Lye, Steve Warr, Gary Finka, and Mark Uden (Conference Proceeding)

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Risk Reduction in Single-Use Assemblies by Implementing Helium Integrity Test and a New Point-of-Use Leak Test Using Palltronic® Flowstar LGR Instrument for Critical Formulation and Filling Applications, Anil Kumar, Vishwas Pethe, Ralf Kuriyel, and Helene Pora (Conference Proceeding)

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Evaluation of sweeping as an alternative to sparging in a rectangular single-use bioreactor, Jean Francois Hamel (Conference Proceeding)

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Evaluation of single-use bioreactors for the production of a Hepatitis C vaccine candidate, Ricardo Silva, Joao Clemente, Rute Castro, Lenaig Savary, Alex Xenopoulos, Cristina Peixoto, Manuel Carrondo, and Paula Alves (Conference Proceeding)

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Particulates reduction efforts in Single Use technologies: A case study, Klaus Wormuth, Royce Brockett, and Mathieu Labedan (Conference Proceeding)

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Robust, fast and accurate pH sensing platform solution targeting Single Use application, Srinivas Rao, Hardjinder Ladhar, and Jai Krishnamurthy (Article)

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Microbial applications of Single Use bioreactor systems, James Rutley and Gary Lye (Conference Proceeding)

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Grey space bioprocessing: Myth or reality?, Diana Lok and Ekta Mahajan (Conference Proceeding)