May 7-10, 2017 - Hotel dos Templários Tomar, Portugal

Editors:   Ekta Mahajan, Genentech, Inc., USA
  Gary Lye, University College London, UK
  Regine Eibl-Schindler, Zurich University of Applied Science, Switzerland

The articles for these proceedings are not peer-reviewed.



Conference Program, Ekta Mahajan, Gary Lye, and Regine Eibl-Schindler (Article)

Bioprocessing 101: Cells to proteins, operations to processes, control to quality, Gary Lye (Abstract)

Manufacturing of therapeutic antibodies and opportunities for single use technologies, Veronica Carvalhal (Abstract)

Manufacturing processes and strategies for cell and gene therapy products, Qasim Rafiq (Abstract)


Tie layer technology for multilayer coextrusion of single-use biopharma bags, Barry A. Morris (Abstract and Presentation)

What are gels and how to reduce them?, Xueyuan Wang and Russell Wong (Abstract)


Influence of γ-irradiated biopharmaceutical films, Samuel Dorey; Fanny Gaston; Magali Barbaroux,; Nathalie Dupuy; and Sylvain R.A. Marque (Abstract and Presentation)

Rapid prototyping of a single-use bioreactor: conceptional design studies to final product, Stephan C. Kaiser (Abstract)


On the “Fate of Leachables” in biopharmaceutical up-stream and down- stream processes, Armin Hauk, Ina Pahl, Roberto Menzel, Samuel Dorey, and Isabelle Uettwiller (Abstract and Presentation)

Standardized extraction protocols for single use components: insights and lessons learned from Implementation of USP, BPOG, and historical protocols, James Hathcock (Abstract)


The journey of a polymer producer to support customers E&L needs, Jerome Vachon (Abstract and Presentation)

Case Study: Subjecting A well-characterized biocontainer film to the standardized bpog extractables protocol, Christian Julien (Abstract)


Roll-to-Roll pilot line for large-scale manufacturing of microfluidic devices, Martin Smolka, Anja Haase, Ursula Palfinger, Dieter Nees, Ladislav Kuna, Jan Hesse, Barbara Stadlober, Sascha. Geidel, Jörg Nestler, Nikolaus Ladenhauf, Andoni Rodriguez, Florian Hasenöhrl, Martin Eibelhuber, Max Sonnleitner, Guggi Kofod, Dan Kofoed, Jan Kafka, Isbaal Ramos, Manuel W. Thesen, Mirko Lohse, Ana Ayerdi, and Nerea Briz (Abstract and Presentation)

Integrated optical sensors for disposable microfluidics, Torsten Mayr, Martin Strobl, Martin Strobl, Martin Strobl, Martin Strobl, Birgit Ungerböck, and Birgit Ungerböck (Abstract)

Contactless microwave sensors and their application in biological single use, Thomas Nacke, Yahor Zaikou, Daniel Martin, Robert Kuehler, Brian P. Cahill, Caspar Demuth, Ralf Klukas, and Iris Poggendorf (Abstract)

Live biomass sensors and their integration and application in single use technology, John Carvel and Aditya Bhat (Abstract)


Of SUT and stainless, Manuel Carrondo (Abstract and Presentation)


Protein-specific empirical model of protein adsorption on surfaces, Dan Nicolau (Abstract and Presentation)

Hydroperoxide generation in irradiation-sterilized SUS and potential risks of protein oxidation, Matthew Hammond, Samuel Dorey, and Jonathan Cutting (Abstract)

Chemical identity and mechanisms of action and formation of a cell growth inhibitory leachable compound from disposable polycarbonate plastic vessels, Zara Melkoumian and Ye Fang (Abstract)

Leachables from single-use systems and impact to product quality, Nina Xiao, Adithi Chandrasekhara, Miguel Saggu, Ed Hoff, and Ankit Patel (Abstract)

Standardized expansion of human adipose tissue-derived stromal/stem cells (hASCs) in wave-mixed single-use bioreactors with one- dimensional motion, Valentin Jossen, Cedric Schirmer, Regine Eibl, Dieter Eibl, Matthias Kraume, and Ralf Pörtner (Abstract)

Characterization of a single-use stirred-tank bioreactor vessel for microcarrier-based adherent cell culture processes using experimental and computational fluid dynamics studies, Marco Rotondi, Qasim A. Rafiq, Christopher J. Hewitt, Alvin W. Nienow, John Betts, Neil Bargh, and Ned Grace (Abstract)

Mixing and fluid dynamics characteristics in single-use bioreactors for improved design and scalability, Martina Micheletti, Gary Lye, Andrea Ducci, and Gregorio Rodriguez (Abstract)

Implementation of single-use technologies for antibody conjugation processes, Dana A. Olson, Matt Hutchinson, Ekta Mahajan, Xin Xin Lin, and Rachel Hendricks (Abstract)

Microbial cultivation in rocking single-use bioreactors, Stefan Junne, Anna-Maria Marbà Ardébol, Peter Neubauer, Vera Meyer, Tutku Kurt, and Howard Ramirez Malule (Abstract)

An automated single-use platform for production of patient specific cell therapies, Gary Lye, Rosario Scott, Waqar Hussain, Paul Mondragon-Teran, and Farlan Veraitch (Abstract)


Single use droplet Based Microfluidics – Screening Tools for Biotechnology and Life-Sciences, Alexander Groß, Jialan Cao, Stefen Schneider, J.M. Köhler, Thomas Henkel, Martin Roth, Mark Kielpinsky, and Alexander Mendel (Abstract and Presentation)

A risk-based framework to manage single-use systems over lifecycle: Design, cleaning, operation, ongoing process verification, Pedro Felizardo; Silvia, C. Ribeiro; Ana G. Henriques; and Pedro M. Felizardo (Abstract)

Application of alternative cell separation systems for the harvest of mammalian cell culture processes in a fully disposable single-use facility, Daniel Bock, Dominique Monteil, Jessica Maier, Kevin Michal, Jeffrey Kuan, Marcella Yu, Jon Coffman, Henry Lin, and Meena George (Abstract)


Characterization of silicone tubing – Effect of pressure and irradiation on tubing diameter, Lise Tan-Sien-Hee, Csilla Kollar, Andrew Diehl, Ernie Jenness, and Pietro Perrone (Abstract and Presentation)

Cell culture scale-up in BioBLU® c rigid-wall, single-use bioreactors, Steffen Ostermann, Xiaofeng Han, Stacey Willard, and Ma Sha (Abstract)

Test method development for next-generation bioprocessing applications, Andrew Burns, Terry Saunders, Hongyi Zhou, K. Amanda Misner, Norberto Silvi, Gregory Goddard, Scott Miller, Ross Acucena, Susan Burke, and Eugene Boden (Abstract)

Large-scale assessment of Extractables and Leachables in single-use bags for biomanufacturing using ultra high performance liquid chromatography coupled to quadrupole-orbitrap mass spectrometry, Noemi Dorival, Christine Ta, Sara Carillo, Jonathan Bones, Kate Comstock, Tim Liddicoat, and Kyle D’Silva (Abstract)

Case study: Development of a helium-based supplier integrity testing method for Single-use Systems (SUS) integrated into a global Container Closure Integrity (CCI) strategy, Marc Hogreve (Abstract)


Improving single use bioreactor design and process development using the HyPerforma 5:1 S.U.B, Michael Goodwin (Abstract and Presentation)

Fed-Batch E. coli cultures in a shaken, single-use 24-well miniature bioreactor, Mary A. Lunson, Gary B. Finka, Steve R.C Warr, and Gary J. Lye (Abstract)

Monitoring of metabolic parameters of mammal cells cultures in microfluidic devices using integrated optical chemical sensors, Bernhard Mueller, Philipp Sulzer, Martin Strobl, Torsten Mayr, Helene Zirath, Mario Rothbauer, and Peter Ertl (Abstract)

Sensors for single-use bioreactors - a review of perspectives and challenges, Caspar Demuth (Abstract)

Analysis of leachable Bis Di-tert-butyl Phenyl Phosphate (bdtbpp) in bioprocessing films, Ross Acucena, Andrew Burns, Eugene Boden, Sara Ullsten, Gregory D. Goddard, and Susan Burke (Abstract)

Production and purification of influenza virus like particles using single-use technologies, Sofia B. Carvalho, Ricardo Silva, Bárbara Cunha, Sofia Moreira, João Clemente, Paula Alves, Manuel Carrondo, Cristina Peixoto, and Alex Xenopoulos (Abstract)

Assessing the impact of single use systems on patient safety, Chrisitan Heiss, Thomas Broschard, and Jessica Shea (Abstract)

Extractables studies on single-use components in the manufacture of antibody drug conjugates (ADCs), Susan Burke, Karin Isaksson, Anna Grönberg, and Fredrik Lundström (Abstract)

Study on mixing and suspension characteristics in single-use shaken microwell systems, Yi Li, A. Ducci, and M. Micheletti (Abstract)

BPOG model solvent comparison for extractables testing for single use systems, Paul Killian and Jessica Shea (Abstract)

Online capacitance measurement for biomass monitoring over cultivation scales and platforms, Stuart Tindal, Jochen Scholz, and Sebastian Ruhl (Abstract)

Utilizing single-use technology for diabetes monitoring via breath acetone, Ronny Priefer and Michael Rust (Abstract)

Role of enzyme immobilization in the formulation of enzymes for single use, Juan M. Bolivar and B. Nidetzky (Abstract)

Development of a pre-screening method for bDtBPP, a cytotoxic leachable from single-use bioprocessing containers, Christine Ta, Noemí Dorvial García, Sara Carillo, and Jonathan Bones (Abstract)

Leak testing of single-use biocontainer for bulk product storage and transport using flow measurement instrument, Kevin Chau, Jacky Dang, Anil Kumar, and Nathalie Pathier (Abstract)


XDR-500 MO—Single-use fermentor for microbial processes, Jozsef Vasi, Andreas Castan, and Sandeep Kristiansson (Abstract and Presentation)

Single-use primary capture technology with the promise to deliver new standards for the economics, convenience and reliability of mAb bioprocessing, Oliver Hardick, Will Lewis, and Daniel G. Bracewell (Abstract)

Comparative study for the production of MABs in single-use (SUB) vs. stainless-steel bioreactors (SSB) based on product quality and stress factorsComparative study for the production of MABs in single-use (SUB) vs. stainless-steel bioreactors (SSB) based on product quality and stress factors, Christian Beck, Christoph T.A. Meiringer, Silke Werz, and Alexander P.O. Herrmann (Abstract)


Particulate contamination in single use systems: Measurement challenges, Klaus Wormuth, Fanny Gaston, and Mathieu Labedan (Abstract and Presentation)

Cellular response of CHO cells following exposure to extractables and leachables from single-use bioreactors, Sara Carillo, Noemí Dorival Garcia, Christine Ta, Jonathan Bones, Niall Barron, Sam Pare, and Paul S. Kelly (Abstract)

Managing risk and consistency in the raw material supply chain for single use systems, Tiffani M. Burt, Nicholas Berendt, Jennifer Foreman, Susan Burke, and Ross Acucena (Abstract)

Recommendations for the engineering characterization of single-use bioreactors, Stephan C. Kaiser, Dieter Eibl, Sören Werner, Thomas Dreher, and Ute Husemann (Abstract)

Process development of human mesenchymal stem cell microcarrier culture using a single-use automated microbioreactor platform, Qasim A. Rafiq (Abstract)

Case study: Relevance of ASTM and ISTA standard shipping simulation studies for the validation of real world shipping of drug substances, Frederic Bazin and Elisabeth Vachette (Abstract)


Effect of agitation on protein aggregation in vials made from glass or plastics, Birgit Mueller-Chorus, Erica Tullo, Vinod Vilivalam, and Lloyd Waxman (Abstract and Presentation)

Combining single-use bioreactor technology and TIPS method to make IC/BEVS- based productions more efficient, Renate Lombriser, Ina Dittler, Katharina Blaschczok, Regine Eibl, and Dieter Eibl (Abstract)

Optical glucose sensor for single use microfluidic reactors, Philipp Sulzer, Mayr T, and Altenhuber N (Abstract)

Collaborative progress toward standardization of user requirements for single-use bioprocess technology, Trishna Ray-Chaudhuri and Susan Burke (Abstract)