May 8-13, 2016 - NH La Quinta (Palm Springs area), California, USA

Editors:   Robert Kiss, Genentech
  Sarah Harcum, Clemson University
  Jeff Chalmers, Ohio State University

The articles for these proceedings are not peer-reviewed

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CHO cell culture process impacts monoclonal antibody trisulfide modification and sulfhydryl-drug conjugation, Michael Hippach (Abstract)

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Critical process parameter identification using the ambr15(tm) for process characterization, Matthew Zustiak, Michael Bennett, Stephanie Chakravarty, and Matt Caple (Abstract)

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Influence of cultivation parameters or supplement on product qualities and culture performances during perfusion, Kyu Kim, Sam Seol, Soo Ryu, Sang Park, Sun Kim, and Seung Lee (Abstract)

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Reduction of N-glycan profile variation by using capacitance probes for optimized process control, Christopher Bro, Tom Kristensen, Michael Wahlers, An Zhang, and Anne Tollstrup (Abstract)

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Advanced process monitoring and feedback control to enhance cell culture process production and robustness, An Zhang, Valerie Tsang, Brandon Moore, Vivian Shen, Yao Ming Huang, and Rashmi Kshirsagar (Abstract)

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Monitoring live stem cells in suspension and attached to carriers in conventional and single use bioreactors, John Carvell and Aditya Bhat (Abstract)

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Monitoring live biomass in disposable bioreactors in range of vessel formats, Dan Kopec (Abstract)

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Use of an automated, integrated laboratory environment to enable predictive modeling approaches for identifying critical process parameters and controlling key quality attributes, Brandon Downey, John Schmitt, Jeffrey Breit, Brian Russell, Justin Beller, Liz Herman, Anthony Quach, and David Lyon (Abstract)

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Softsensors: New approach for process monitoring cell growth in small scale fermentation systems, Wolfgang Paul, Daniel Christofori, Bernhard Keil, and Arthur Mohr (Abstract)

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Advancement of cell culture process understanding and control through real-time multivariate process monitoring, use of statistical process modes and deployment of process analytical technologies, Patrick Gammell, Thomas Mistretta, Cenk Undey, Eric Kwei, Tonny Wang, and Greg Naugle (Abstract)

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Agent-based model predictive framework to control cell culture bioreactors, Elif Bayrak, Tony Wang, Myra Coufai, Ali Cinar, and Cenk Undey (Abstract)

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Kinetic physico-chemical model for cell culture processes – applications and opportunities, Natraj Ram, Kartik Subramanian, and John Ponzo (Abstract)

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Accelerate cell culture development using the modular automated sampling technology (MASTTM) platform in an integrated bioprocess lab environment, Clinton Pepper (Abstract)

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Development of bioreactor auto-sampling system for real time product quality monitoring in mammalian cell culture, Meena George (Abstract)

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Lensless imaging for continuous CHO viable cell density monitoring in bioreactors, Geoffrey Esteban, Martin Pisaneschi, Jeremie Cubeta, and David Sergeant (Abstract)

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Continuous suspension cell culture monitoring in bioreactors using quantitative imaging, Ann D'Ambruoso, Jeremie Barbau, and Denis Haumont (Abstract)

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Investigating the reverse Warburg effect: How high extracellular lactate alters breast cancer metabolism, Daniel Odenwelder, Sarah Harcum, and Arthur Brodksy (Abstract)

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Real time prediction and control of glycoform profile of mammalian cell cultures using in silicoglycosylation model coupled with extracellular metabolites, Sha Sha and Seongkyu Yoon (Abstract)

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A stochastic model to study genetic and metabolic effects on N-linked protein glycosylation, Phillip Spahn, Anders Hansen, Henning Hansen, Johnny Arnsdorf, Helene Kildegaard, and Nathan Lewis (Abstract)

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CHO-specific recombinant protein glycosylation reaction network, Benjamin Kremkow and Kelvin Lee (Abstract)

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Controller design for effective glycosylation control in mAbs, Devesh Radhakrishnan (Abstract)

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Elucidating glycosylation pattern of protein produced in mammalian cells, Tung Sy Le (Abstract)

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Poly-pathway model approach: Simulation of multiple metabolic states, Erika Hagrot (Abstract)

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Improved scale-down model development case study for raw materials screening, Angela Au, Davanna Marks, and Hugh Graham (Abstract)

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Characterization of TAP Ambr250 disposable bioreactors as a reliable scale-down model for biologics process development, Ping Xu, Colleen Clark, Todd Ryder, and Charo Scott (Abstract)

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Metabolomic analysis for scale-down model improvement, Eric Garr (Abstract)

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Demonstrating process performance comparability of the Keytruda® upstream process after transfer and scale-up to different manufacturing sites, Jurgen van de Lagermaat (Abstract)

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Challenges in the use of scale-down models for understanding and mitigating process variations of a monoclonal antibody production process, Peter Russo (Abstract)

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Scale-up in the single use age: Does geometry matter?, Colin Jaques and Anthony Beaney (Abstract)

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A rapid approach for basal and feed media optimization in ambr® 15 bioreactors, Michael Gillmeister (Abstract)

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Tubespins as a suitable scale-down model of 2L high cell density bioreactors for CHO cell culture, Natalia Gomez (Abstract)

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Process scale-up issues: Relics of the past or continues to cause major headaches, Sadettin Ozturk (Abstract)

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Novel, efficient scale-up of inclined settlers for perfusion bioreactor cultures, Dhinakar Kompala (Abstract)

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Bioreactor scale-up harmonization - From process development to manufacturing, Claudia Berdugo-Davis (Abstract)

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Scale-up and scale-down topics facing the industry, Markus Michael Muller (Abstract)

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Case study for improved process robustness at manufacturing scale for a mammalian cell culture process: Troubleshooting medium preparation and gas entrance velocity effects, Robin Luo (Abstract)

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Performance consistency of fed-batch cultures across multiple systems used in upstream process development, Matthieu Stettler, Jean Marc Bielser, Yolande Rouiller, Martin Jordan, and Herve Broly (Abstract)

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Overcoming scale-up challenges with a non-robust cell line, Sigma Mostafa, Brian Baker, and Abhinav Shukla (Abstract)

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Application of online CO2 monitoring to enable a better understanding of cell culture performance variation between GMP-scale and scaled-down bioreactors, Ting Kuo Huang, Jacob Mauger, and James Dvornicky (Abstract)

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Establishing a pH measurement reference method for site/process transfer purposes, Meg Tung, Jacob Mauger, Christian Klinger, and Detlef Eisenkratzer (Abstract)

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Case study: Lessons learned during tech transfer at a multi-product legacy launch facility, Arthi Niarayanan (Abstract)

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Scale down model in industrial cell culture processes – A powerful tool to ensure reliable production, Marco Jenzsch (Abstract)

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Advances in Bioreactor Scale-Down Modeling Using Process Analytical Technology, LiYing Yang, Jimmy Liu, and Benjamin D'Alessio (Abstract)

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

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A holistic approach to the scale-up of a microcarrier-based perfusion cell culture process for the production of a therapeutic enzyme, Jin Yin (Abstract)

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Bioreactor process improvements in a legacy perfusion-based process, Rakesh Motani, Gonzalo Milet, Gregory Walsh, and Lada Laenen (Abstract)

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Preferentially selecting cellular metabolism and improving productivity by controlling do and Pco2, Jiayi Zhang, Ryan Cassidy, Mark Emanuele, Gonzalo Milet, and Lada Laenen (Abstract)

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Challenges and their resolutions during process development and tech transfer of a late stage bispecific antibody product, Marcela Yu (Abstract)

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Scalability of the Mobius® single-use bioreactor from bench to clinical scale: Examination of key engineering parameters and robustness, Lee Madrid (Abstract)

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Single-step flask to 250 L cell culture with a hybrid mixing single-use bioreactor, Nephi Jones and Tony Hsiao (Abstract)

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Rapid development of a perfusion process with high productivity, Sen Xu, Linda Hoshan, Balrina Gupta, and Hao Chen (Abstract)

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Integrated continuous bioprocessing - a gold mine for cell culture process understanding?, Mats Akesson, Martin Heitmann, Ditte Skibstrup, and Peter Tiainen (Abstract)

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Perfusion media development and evaluation with spin tube and ambr15 highthroughput small-scale models, Yang Wang, Shawn Barrett, Borka Naumovich, Jessica Nichols, and Steve Gorfien (Abstract)

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Process intensification through integration of upstream perfusion cell culture with downstream continuous chromatography in monoclonal antibody production, Andreas Castan, Thomas Falkman, Eric Faldt, Teres Persson, Lisa Blomqvist, and Annika Forss (Abstract)

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Modeling perfusion for medium component optimization using ambr15TM, Deila Lyons (Abstract)

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Small-scale comparison of pseudoperfusion feeding strategies using basal and concentrated feed media, Iona Bettinardi and Leda Castiho (Abstract)

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Towards integrated continuous viral vaccines production using two-stage bioreactor systems, Felipe Tapia (Abstract)

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Development of a qualtiy driven integrated continuous biomanufacturing process, Daniel Karst, Fabian Steinenbach, Thomas Villiger, Miroslav Soos, and Massimo Morbidelli (Abstract)

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mAb product consistency in long duration microfiltration-based CHO perfusion process, Douglas Rank, Patrick McInnis, Christopher Martin, and Michael Phillips (Abstract)

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Toward development of continuous bioprocesses: Comparison of fed-batch and perfusion upstream production processes in early development, Jean McLarty, Daryl Powers, Christine Hamel, Betsy Simons, and Ken Karey (Abstract)

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Process intensification of perfusion: To steady-state, or unsteady-state, that is the question, Henry Lin (Abstract)

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Size matters: Assessment of a larger pore hollow fiber to reduce product retention in perfusion, Samantha Wang (Abstract)

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Process robustness and cell line variation in N-1 high density perfusion system, Haofan Peng (Abstract)

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Process optimization for semi-continuous virus production at high cell densities, Daniel Vazquez (Abstract)

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Non-invasive real-time monitoring of glucose and lactate by NIR-spectroscopy during perfusion CHO culture, Jean Hamel, Anita Wamakima, and Ruifan Pei (Abstract)

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Understanding and overcoming process insults through application of ‘omics technologies, Alan Gilbert, Kyle McElearney, Smitha Krishnan, Nicholas Alden, WIlliam Yang, Kyongbum Lee, and Rashmi Kshirsagar (Abstract)

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Technical evaluation of RNA-Seq and microarray approaches in comparative transcriptomics analysis of CHO cells, Chun Chen, Huong Le, and Chetan Goudar (Abstract)

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Evaluation of public genome references for RNA-Seq data analysis in Chinese Hamster ovary cells, Huong Le, Chun Chen, and Chetan Goudar (Abstract)

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Increasing diversity of production cell lines through miniaturization, automation, and high-throughput analytics, Kim Le, Hannah Victor, Kristi Daris, and Trent Munro (Abstract)

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Utilizing RNA-Seq technique to improve molecular understanding of Chinese Hamster ovary (CHO) cell bioprocessing, Yogender Kumar, Christpher Saski, and Sarah Harcum (Abstract)

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Manipulation and exploitation of MicroRNAs for enhanced recombinant protein production in CHO cells, Tulshi Patel, Lyne Josse, Mark Smales, and Robert Young (Abstract)

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Implementation and evaluation of a high-throughput siRNA screening system for suspension CHO cells, Gerald Klanert, Daniel Fernandez, Vaibhav Jadhav, and Nicole Borth (Abstract)

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Lipidomic analysis to enhance the understanding of Chinese Hamster ovary cells, Yue Zhang, Deniz Baycin, Michael Bowen, and Michael Betenbaugh (Abstract)

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Lipidomics for robust high performance process development, Laetitia Malphettes, Gregory Mathy, and Laura Gimenez (Abstract)

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High titer transient gene expression platform based on GS CHO cell line – rapid protein expression tool for preclinical drug development, Yasha Rajendra and Gavin Barnard (Abstract)

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Improving biologics development by high performance glycoanalysis, Erdmann Rapp (Abstract)

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Genomics based methodology of cell-culturemedia formulation for improved biotherapeutic productivity and quality consistency, Hemlata Bhatia and Seongkyu Yoon (Abstract)

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Multi-omic profiling of EPO producing CHO cell panel reveals metabolic adaptation to heterologous protein production, Daniel Ley (Abstract)

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A multi-omic approach to understanding recombinant protein degradation in Chinese Hamster ovary cells, Ronan Kelly (Abstract)

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Multi-omic modeling of translational efficiency for synthetic gene design, Joseph Longworth, Javier Gonzalez, Paul Dobson, Josselin Noirel, and Neil Lawrence (Abstract)

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Enhancing site-specific CHO produced antibody through media optimization using metabolomics approach, Ching Yang (Abstract)

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A correction method for systematic error in metabolomic time-course data, Stanislav Sokolenko and Marc Aucoin (Abstract)

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Integration of transcriptomic data with a genome-scale model reveals key metabolic features of high producer CHO cell lines, Natalia Jimenez (Abstract)

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Development of plate-based sialic acid assays to support clone screening and early Stage upstream process development, Julie Gardin and Yvette Tang (Abstract)

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Site-specific glycan analysis of proteins in cell culture conditioned media and subcellular fractions by LC-MS/MS for understanding the impact of process conditions on N-glycosylation, Karina Bora de Oliveira, Nitin Agarwal, and Christopher Barton (Abstract)

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A community genome-scale model of Chinese Hamster ovary cell metabolism identifies differences in the efficiency of resource utilization for various bioprocesses, Hooman Hefzi (Abstract)

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A bioinformatic pipeline for studying ribosome occupancy in CHO cells, Shangzhong Li (Abstract)

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13C flux analysis in industrial CHO cell culture applications, Allison McAfee and Jamey Young (Abstract)

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Elucidating cell line and tissue differences derived from cricetulus griseus by transcriptomics and proteomics, Kelley Heffner (Abstract)

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Scale-down and initial characterization studies of an allogeneic cell therapy manufacturing process, Thomas Brieva (Abstract)

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Expansion and differentiation of T cells under defined xeno-free culture conditions, Jessie Ni (Abstract)

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Cell therapy manufacturing strategies: Impact on cost of goods, cost of development and commercialisation, Suzanne Farid (Abstract)

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An innovative protein delivery system for therapeutic cells, Jean Pascal Lepetit (Abstract)

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Effect of cell-surface interactions on monocyte-derived immunotherapy products, Corinne Hoesli (Abstract)

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Optimization of a defined serum-free medium for the production of therapeutic human myoblasts, Alain Garnier (Abstract)

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Biological relevance of YAP regulation by Wnt signaling during neural tissue patterning of human induced pluripotent stem cells, Yan Li (Abstract)

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PCL-PDMS-PCL copolymer-based microspheres mediate cardiovascular differentiation from embryonic stem cells, Yan Li (Abstract)

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Neural patterning of human induced pluripotent stem cells for studying neurotoxicity, Yan Li and Yuanwei Yan (Abstract)

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Human cardiac stem cells for allogeneic cell therapies: integrating bioprocess development and ‘omics characterization tools, Patricia Gomes (Abstract)

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Integrated strategies for the production, maturation and storage of functional cardiomyocytes derived from human pluripotent stem cells, Claudia Correia and Paula Alves (Abstract)