May 6-11, 2018
Saddlebrook Resort
Tampa, Florida, USA

Editors:   A. Robinson, PhD, Tulane University.
  R. Venkat, PhD, MedImmune
  E. Schaefer, ScD, J&J Janssen

The articles for these proceedings are not peer-reviewed.

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Conference Program, Anne Skaja Robinson, Raghavan Venkat, and Gene Schaefer (Article)

The human protein atlas: Implications for human biology, drug development, and precision medicine, Mathias Uhlén (Abstract)

Moving Beyond CHO: Alternative host systems may be the future of biotherapeutics, Christina Alves, Chapman Wright, Matthew Westoby, Venkatesh Natarajan, Heather Saforrian, Carl Co, Hanxiao Jiang, and Christopher Love (Abstract)

Insect cell platforms for production of pseudo-typed VLPs for drug and vaccine development, Antonio Roldao, Marco Patrone, Manuel Carrondo, Paula Alves, Ana Teixeira, Barbara Fernandes, and João Vidigal (Abstract)

Production of biopharmaceuticals in an intensified perfusion process of HEK 293 cells, Johan Rockberg, Caijuan Zhan, Magdalena Malm, Hubert Schwarz, Magnus Lundqvist, Atefeh Shokri, Ray Field, Richard Turner, and Veronique Chotteau (Abstract)

Beyond CHO cells: Cell-free protein synthesis for biotherapeutics, Bob Kiss, James Zawada, Dawei Yuan, Maureen Bruhns, and Robert Hoffman (Abstract)

Engineering CHO cells for the production of "Hard-To-Produce" proteins, Bjørn Voldborg, Stefan Kol, Johnny Arnsdorf, Anders Holmgaard Hansen, Tune Wulf, Marianne Decker, Helene Faustrup Kildegaard, Hooman Hefzi, Nathan Lewis, Bernhard Palsson, and Johan Rockberg (Abstract)

CRISPR/Cas9 mediated knockout of microRNAs for precise cell engineering, Nadja Raab, Kerstin Alt, Sven Mathias, René Handrick, Vaibhav Jadhav, and Kerstin Otte (Abstract)

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miR-CATCH identifies biologically active miRNA regulators of the pro-survival gene XIAP, in Chinese hamster ovary cells, Paul S. Kelly, Alan Griffith, Sebastian Vencken, Nga T. Lao, Martin Clynes, and Niall Barron (Abstract and Presentation)

Glycoengineering of CHO cells for production of recombinant therapeutics with enhanced efficacy, Zhiwei Song (Abstract)

Elimination of the “Essential” Warburg effect in CHO cells through a multiplex genome engineering strategy, Nathan E. Lewis, Hooman Hefzi, Soo Min Noh, Iván Martínez Monge, Nusa Pristovsek, Bjorn Voldborg, Helene Faustrup Kildegaard, Lars K. Nielsen, Helle Munck Petersen, Sara Petersen Bjorn, Patrice Ménard, Karen Kathrine Brondum, Zulfiya Sukhova, Johnny Arnsdorf, Stefan Kol, Anders Holmgaard Hansen, Kristian Jensen, Elham Maria Javidi, Marianne Decker, and Gyun-Min Lee (Abstract)

Limitations of subcloning as a tool to characterize homogeneity of a cell population, Jennitte Stevens, Nicole Tejeda, Tharmala Tharmalingam, Pheng Yam, Sam Yaghmour, Trent Munro, Chetan Goudar, and Hedieh Barkhordarian (Abstract)

Registration enabling campaign for accelerated development: A PPQ strategy with minimal early investments to enable fast to market development for a promising monoclonal antibody, Jessica Wuu and Kristen Koterba Douglas (Abstract)

Derivation of process control strategy for biosimilar: Is it different from the way a control strategy is derived for a novel biologic?, Dinesh Baskar, Chandrashekhar KN, Saravanan Desan, Ankur Bhatnagar, and Anuj Goel (Abstract)

Confronting the Analytical Challenges of Chimeric Antigen Receptor T Cell, Heidi Zhang (Abstract)

Large scale production and characterization of exosomes, Konstantin Konstantinov (Abstract)

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Cell Culture Bioprocess Learnings: Past successes and future challenges, Günter Jagschies (Abstract and Presentation)

Intensification of a multi-product perfusion platform – managing growth characteristics at high cell density for maximized volumetric productivity, Shawn Barrett, Jared Franklin, Mara Stangl, Aleksandar Cvetkovic, and Wenqin He (Abstract)

Evolution of TFF-based perfusion: A path towards non product sieving and direct chromatography integration, Nuno D. S. Pinto (Abstract)

Development towards a high-titer fed-batch CHO platform process yielding product titers > 10 g/L, Laurel Zhang, Robert Shawley, Martin Gawlitzek, and Brian Wong (Abstract)

Development of a novel automated perfusion mini-bioreactor ambr® 250 perfusion, Barney Zoro, Andrew Tait, Melisa Carpio, and Kevin McHugh (Abstract)

Intensified cell culture using a linked bioreactor system, Matthew Gagnon and Gregory Hiller (Abstract)

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Advances in Cell Line Engineering and Protein Expression Strategies, Steven Lang and Diane Hatton (Article)

CAR T Cell Therapy: Fifteen years of academic driving, Isabelle Rivière (Abstract)

Engineered CAR T cell therapy for solid tumors, Juan F. Vera, Pradip Bajgain, Sujita Sukumaran, Alejandro Torres, Norihiro Watanabe, Malcolm Brenner, and Ann Leen (Abstract)

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iPSC-derived neurospheroids recapitulate development and pathological signatures of human brain microenvironment, Catarina Brito, Ana Paula Terrasso, Daniel Simão, Francisca Arez, Marta M. Silva, Patrícia Gomes-Alves, Paula M. Alves, Marcos F. Sousa, Nuno Raimundo, Neus Bayó-Puxan, Sophie Creysells, and Eric J. Kremer (Abstract and Presentation)

Biomanufacturing of platelet-like cells and cell microparticles for cell therapy applications, Eleftherios T. Papoutsakis, Chen-Yuan Kao, and Christian Escobar (Abstract)

CAR T manufacturing: process modifications for a transformational autologous product on a rapid path to licensure, Thomas Brieva, Seth Jones, Shiv Misty, Sherry Zhou, David Hsiung, Eric Law, Ryan Glussi, Ryan Shorr, Kevin Friedman, Molly Perkins, Shannon Grande, Kruti Shah, Jaymes Fuller, Holly Horton, Christopher Wiwi, and Greg Russotti (Abstract)

Development of a large scale GMP compliant suspension cell culture system for the manufacturing of allogenic Exosome-based biotherapeutics, Scott Estes, Agata Villiger-Oberbek, Andrew Grube, Tik Yan (Emily) Chan, and Konstantin Konstantinov (Abstract)

Probing lactate metabolism variations in large-scale bioreactors, Sen Xu, Rubin Jiang, Roland Mueller, Nadja Hoesli, Thomas Kretz, Hao Chen, and John Bowers (Abstract)

Medium development strategies and scale down models for a high density high productivity cell line, Amy Johnson, Meghan E. Casey, Nancy Guillen, and Shawn M. Lawrence (Abstract)

Process scale up and characterization of an intensified perfusion process, Jiuyi Lu, Jonathan Wang, Myles Hollenbach, Jason Walther, Jean McLarty, and Ken Karey (Abstract)

Leveraging a technical partnership to deliver high titer biologics manufacturing, Haofan (Eric) Peng (Abstract)

Efficient technology transfers to increase agility, flexibility, and productivity, Kara Calhoun (Abstract)

Towards advanced understanding of scale-up: From computational fluid dynamics to systems biotechnology approaches, Jochen Schaub, Anna Wippermann, Carina Guelch, Christoph Hold, Martina Berger, Thomas Wucherpfennig, and Jan Bechmann (Abstract)

Understanding and improving cell culture processes through omi, Amanda Lewis (Abstract)

Application of -omics knowledge yields enhanced bioprocess performance, Rashmi Kshirsagar; Ravali Raju; Amr Ali; Chris Kwiatkowski; Kyle McElearney; and Alan Gilbert, (Abstract)

Multivariate data analysis enabling improved clone selection, Stephen Goldrick, Nicholas J. Bond, Clare Lovelady, Rahul Pradhan, Richard Turner, and Suzanne S. Farid (Abstract)

Quantifying the partition of demoresources between cellular and recombinant protein glycosylation in GS-CHO cells, Ioscani Jimenez del Val,; Sarantos Kyriakopoulos; Simone Albrecht; Henning Stockmann; Pauline M. Rudd; Karen M. Polizzi; and Cleo Kontoravdi (Abstract)

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More accurate process understanding from process characterization studies using Monte Carlo simulation, regularized regression, and classification models, Cary Opel, Cerintha J. Hui, Patrick Y. Yang, Daniel J. Tien, Gayle E. Derfus, and Rajesh Krishnan (Abstract and Presentation)

Enhancing CHO process understanding from CHO manufacturing process data, Tom Mistretta, Patrick Gammell, Cenk Undey, and Greg Naugle (Abstract)

Gaussian mixture models and machine learning predict megakaryocytic growth and differentiation potential ex vivo, William M. Miller, Neda Bagheri, Jia J. Wu, Darryl A. Abbott, Nadim Mahmud, Dolores Mahmud, and Meryem K. Terzioglu (Abstract)

Automated and enhanced clone screening using a fully automated microtiter plate-based system for suspension cell culture, Sven Markert, Carsten Musmann, Peter Hülsmann, and Klaus Joeris (Abstract)

Systems biology approach in the development of chemically-defined media for production of protein therapeutics in Chinese hamster ovary cells, Wai Lam Ling, Taha Salim, Gaurav Chauhan, Neil Templeton, Brian Kwan, Nicholas Murgolo, Jennifer Cho, Qiuwei Xu, Heather Vu, Vaclav Belak, David Dufour Rausell, and Pavlo Minayev (Abstract)

Feedback control of lactate using Raman spectroscopy, Peter Slade, Derrick Ruble, Hamid Mehdizadeh, Jun Huang, Dunie Navarro, and Erwin Yu (Abstract)

An energy-based modelling tool for culture medium design and biomanufacturing optimization, Athanasios Mantalaris, Ana L. Quiroga-Campano, and Nicki Panoskaltsis (Abstract)

Novel modeling methodology to predict product quality and cell culture performance in fed-batch and perfusion cultures, Bassem Ben Yahia, Boris Gourevitch, Elmar Heinzle, and Laetitia Malphettes (Abstract)

From bioreactors for protein therapeutic production to bioreactors for testing efficacy and safety of protein therapeutics, Linda Griffith (Abstract)

Tailoring antibody glycosylation via integrating genome and protein engineering to generate preferred glycoforms on the Fc region, Michael J Betenbaugh (Abstract)

Product quality control strategy development for non-mAb complex modalities by using combinatorial cell engineering and OMICS screening tools, Zhimei Du, Ren Liu, Steve Huhn, Yang Ou, Gregg Nyberg, and Bo Jiang (Abstract)

Controlling tryptophan oxidation through medium/feed modifications and potential MOA unveiled by transcriptomics analysis, Luhong He, Laurie Hazeltine, Jinxin Gao, John Calley, Christopher Frye, and Jairav Desai (Abstract)

Online control of cell culture redox potential prevents antibody reduction, Michael Handlogten and Sanjeev Ahuja (Abstract)

Identification of copper as a cell culture media component causing metabolite depletion and product sequence variants, Brian Mickus, Matt Schenauer, Winnie Yeung, Ambrose Wesel, Daniel Tien, Doug Rehder, Tim Kaschak, Gayle Derfus, Dell Farnan, and Rajesh Krishnan (Abstract)

A synthetic biology based cell line engineering pipeline, Wei-Shou Hu, Christopher S. Stach, Sofie O’Brien, Arpan Bandyopadhyay, Meghan McCann, Conor O’Brien, Zion Lee, Prodromos Daoutidis, Nikunj Somia, Tung Le, Michael J. Smanski, Xinning Chen, and Liang Zhao (Abstract)

Engineering stem cell fate, Peter Zandstra (Abstract)

Future challenges in biologics cell culture engineering, Mike Laird and Lynne A. Krummen (Abstract)

Ignorant empiricism in cell culture engineering: 30 years of expensive lessons, Matt Croughan (Abstract)

Limitations of subcloning as a tool to characterize homogeneity of a cell population, Hedieh Barkhordarian, Tharmala Tharmalingam, Nicole Tejeda, Pheng Yam, Sam Yaghmour, Kristi Daris, Trent Munro, Fang Lu, Chetan Goudar, and Jennitte Stevens (Abstract)

Interrogating cell culture populations for the selection of production cell lines using microfluidic culturing, single cell analysis, and predictive modelling, Kim Le, Chris Tan, Chun Chen, Shivani Gupta, Cai Guo, Hannah Victor, Jennitte Stevens, and Sam Yaghmour (Abstract)

Rethinking clonality using modeling approaches, Chun Chen, Nicole Tejeda, Kim Le, Trent Munro, Jennitte Stevens, Chetan Goudar, and Tharmala Tharmalingam (Abstract)

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Tools and methods for providing assurance of clonality for legacy cell lines, Paul Wu, Juhi Ohja, John Thrift, Taymar Hartman, Louise Almond, Jennitte Stevens, Sam Yaghmour, Christina Alves, David Shaw, Mike Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Howard Clarke, and Chris Campbell (Abstract and Presentation)

Variation in karyotype and chromsome numbers in CHO cell lines and subclones, Nicole Borth, Sabine Vcelar, Vaibhav Jadhav, Martina Baumann, Friedrich Leisch, and Michae l Melcher (Abstract)

Genomic understanding of clonal variation in recombinant CHO cells, Gyun Min Lee and Jae Seong Lee (Abstract)

Characterisation of Chinese Hamster Ovary (CHO) cells at the single cell level, Eva Pekle, Guglielmo Rosignoli, Claire Pearce, Christopher Sellick, Andrew Smith, and Mark Smales (Abstract)

Population dynamics in cloned CHO cell lines, Tzihsuan Jennifer Lin, Kathryn Beal, Karin Anderson, and Danielle Meyer (Abstract)

The relationship between clonality, cellular heterogeneity, and process consistency, Jack J. Scarcelli and Karin Anderson (Abstract)

Process improvement delivered by a high efficiency, automated single cell cloning system, Andrea Gough, Erika Parkinson, and Ian Taylor (Abstract)

Using nanoscale bioreactors to characterize sub-populations of CHO clones and screen transfected pools, Tanner Nevill, Hari Chirra, Troy Lionberger, and Phillip Elms (Abstract)

Quantification of genomic DNA repair capabilities in CHO and identification of genes impacting genomic stability, Philipp N. Spahn (Abstract)

Analysis of DNA DSB repair and production stability in CHO cells, Xiaolin Zhang and Kelvin H. Lee (Abstract)

Integrated analysis of genomic and epigenomic instability for CHO cell line engineering, Sofie O'Brien, Arpan Bandyopadhyay, Conor O’Brien, Zion Lee, and Wei-Shou Hu (Abstract)

The C1 gene expression system, disrupting the way biologic vaccines, and drugs are developed & manufactured, Ronen Tchelet (Abstract)

Opportunities to leverage cell culture technology to create sustainable food systems: The development of "Clean Meat", Liz Specht and Christie Lagally (Abstract)

Expanding the vector toolkit for complex recombinant protein expression, Peter M. O'Callaghan, Andrew Racher, and Robert Young (Abstract)

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Identifying Hipk1 as a target of Mir-22-3p enhancing recombinant protein production from Hek 293 by using microarray and Htp sirna screen, Sarah Inwood, Eugen Buehler, Michael Betenbaugh, Madhu Lal, and Joseph Shiloach (Abstract and Presentation)

spERt Technology: A novel strategy to improve productivity through enhanced polyribosome assembly on the endoplasmic reticulum in CHO cells, Kiyoko Ogawa-Goto, Tomonori Ueno, Yoshiko Yoshioka, Yuko Ushiki-Kaku, Reiko Ohsawa, Yuki Taga, Kenji Masuda, Hisashi Saeki, and Koichi Nonaka (Abstract)

Newly established cell lines derived from Chinese hamster for production of biologics, Takeshi Omasa and Noriko Yamano (Abstract)

Improving vaccine production with a serum-free medium for MRC-5 cells, Anna-Barbara Hachmann, Nicole DiNardo, Andrew M. Campbell, and Jennifer Donato (Abstract)

Use of a ‘molecular tug’ to overcome limitations in the production of ‘difficult to express’ recombinant proteins, Hirra Hussain, David I. Fisher, W Mark Abbott, Robert G Roth, and Alan J. Dickson (Abstract)

Improving bioreactor design through pH mapping of bioreactors employing Computational Fluid Dynamics coupled with equilibrium calculations, Natraj Ram, Kushal Sinha, Ying Wang, Kartik Subramanian, and Nandukishore Nere (Abstract)

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Empowering manufacturing decisions through process simulation models, Tiffany Rau, Terence Davidovits, and Rick Stock (Abstract and Presentation)

Applying genome scale metabolic models integrated with OMICs technologies for improvemwent of commercial CHO cell culture process, Jianlin Xu, Andrew Yongky, Jia Zhao, Nelly Aranibar, Michael Reily, Michael Borys, Zhengjian Li, Seongkyu Yoon, Seoyoung Park, Sha Sha, and Zhuangrong Huang (Abstract)

A bioinformatics approach to genome to phenome predictions in CHO cell lines, Derrick Scott (Abstract)

Multiscale modeling of monoclonal antibody (mAb) production and glycosylation in a CHO cell culture process, Yu Luo, J. Vincent Price, Robert J. Lovelett, Kelvin H. Lee, Babatunde A. Ogunnaike, Devesh Radhakrishnan, Kristopher Barnthouse, John Cunningham, Raghu Shivappa, and Gene Schaefer (Abstract)

Bioprocess intelligent for the improvements and prediction on fed-batch cell culture in bioreactor, Ching-Jen Yang, Ming-Hung Hsu, Dalton Chen, Hsueh-Lin Lu, and Wei-Kuang Chi (Abstract)

Development of an in silico molecule assessment method for product expression, Misha Lazebnik and Laura C. Simmons (Abstract)

Monitoring the production of AAV vectors in insect cells by fluorescence spectroscopy, Daniel Alexandre Marques Pais, Inês A. Isidro, Paula M Alves, and Rui MC Portela (Abstract)

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Towards model-based bioprocess characterization: A mathematical model of cell cycle, metabolism and apoptosis of mAb-producing mammalian cells, António Lima Grilo and Athanasios Mantalaris (Abstract and Presentation)

Application of a genome-based predictive CHO model for increased mAb production and Glycosylation control, J. Vincent Price, Raghunath Shivappa, Kristopher Barnthouse, Eugene Schaefer, John Cunningham, Joachim Bucher, Bastian Niebel, and Averina Nicolae (Abstract)

Dynamics of intracellular metabolite pools in MDCK suspension cells during growth and influenza virus infection, Thomas Bissinger, Yvonne Genzel, Udo Reichl, Jonas Ringeisen, and João Ramos (Abstract)

Application of metabolomics and fluxomics to increase productivity and predict product quality, Neil Templeton, Sen Xu, Rubin Jiang, and Hao Chen (Abstract)

Characterizing the effect of glutamine supplementation on asparagine and glutamine metabolism using 13C metabolic flux analysis, Sandra V. Bennun, Amy S. Johnson, Shawn M. Lawrence, B. James Kirsch, and Michael J. Betenbaugh (Abstract)

Innovative metabolic data integration applicable for Therapeutic Protein Development 2.0, Wolfgang Paul, Tobias Grosskopf, Sriram Venkateswaran, and Arthur Mohr (Abstract)

Biologically consistent annotation of CHO cell culture metabolomics data, Nicholas Alden, Grace Yao, Zhengjian Li, and Kyongbum Lee (Abstract)

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Curation of a CHO DG44 genome scale model and application to support cell culture development process, Cyrielle Calmels, Laetitia Malphettes, and Mikael Rørdam Andersen (Abstract and Presentation)

Filling the gap between experimentalists and modelers by determining a mammalian cell's metabolic capabilities based on transcriptomic data, Anne Richelle and Nathan E. Lewis (Abstract)

A priori optimization of cell culture feeds using metabolic engineering, Nicholas Trunfio, Brittany Chavez, SaiRashmika Velugula, Cyrus Agarabi, and Seongkyu Yoon (Abstract)

Media formulation optimization based on multi-scale modeling of heterogeniety in mammalian cell culture process, Shaun Galbraith, Huolong Liu, and Seongkyu Yoon (Abstract)

RNA-seq data reveals metabolic regulation in Chinese Hamster Ovary cell culture, Sha Sha and Seongkyu Yoon (Abstract)

Metabolic pathway engineering in mammalian cells through kinetic model optimization, Conor M. O'Brien, Andrew Allman, Wei-Shou Hu, and Prodromos Daoutidis (Abstract)