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The articles for these proceedings are not peer-reviewed.

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Epigenetic regulation of gene expression in response to a changing environment in CHO cell batch culture, Heena Dhiman, Inmaculada Hernandez, Norbert Auer, Vaibhav Jadhav, Martina Baumann, Gerald Klanert, Simon Heath, Marc Dabad, Tyler Alioto, Anna Esteve, Jessica Gómez, Daniel Rico, and Nicole Borth (Abstract)

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

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Controlling continuous high cell density perfusion culture with the Alternating Tangential Flow system in real time using radio-frequency impendance, Aditya Bhat (Abstract and Presentation)

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Demonstrating a powerful scale-up strategy for Biosimilar mAb in single use systems via physicochemical and functional characterization, Serdar Alpan, Ozge Can, Deniz Baycin, Yigit Erdemgil, Zeynep Yildirim Keles, and A. Emin Atik (Abstract and Presentation)

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Impact of raw materials on sialyation for a therapeutic protein, Wei-Chien Hung, Mei Shao, Bridget Leslie, John Mavrianos, Paul Loray, and Mei Shao (Abstract and Presentation)

Delivery of consistent and high-quality antibody therapeutics by actively monitoring and controlling critical quality attributes, Megan Blewis, ack Huang, Peter Schindler, Tony Wang, and Tony Wang (Abstract)

Modulation of half antibody and aggregate formation in a CHO cell line expressing a bispecific antibody, Natalia Gomez, Agatha Wieczorek, Richele Bruno, Luis Diaz, Kristi Daris, and Fang Lu (Abstract)

Controllability analysis to identify manipulated variables for a glycosylation control strategy, Melissa M. St. Amand, Mohammed Eslami, Anne S. Robinson, and Babatunde A. Ogunnaike (Abstract)

A novel additive for controlling glycosylation of monoclonal antibodies, Fernie Mitchelson, Greg Cockrell, and Sarwat Khattak (Abstract)

Perfusion cell culture: Challenges and potentials between lab and manufacturing scale, Daniel J. Karst (Abstract)

Process optimization for high volumetric productivity with product quality control, Rashmi Kshirsagar, Alan Gilbert, Kyle McElearney, Ravali Raju, Brandon Moore, Amr Ali, Valerie Pferdeort, and Maria Choi (Abstract)

Study of an unusually high level of N-glycolylneuraminic acid (NGNA) sialylation on a monoclonal antibody expressed in Chinese hamster ovary cells, Shumin Yang; Henry Lin; Yan Ley; Guifeng Jiang; Lin Wang; Kaleb Jentzsch; Anna Peterson; Marcus Strawn; Mandakini Sharma,; Eike Zimmermann; Sara Wright; Lia Tescione; Simon Fischer; Anna Wippermann; Patrick Schulz; Harald Bradl; Martin Gamer; Ingo Gorr; and Holger Thie (Abstract)

A Master Cell Bank (MCB) banking troubleshooting case study: Challenges and process improvements with comprehensive root cause analysis, Lianchun Fan, Kathleen Bierilo, Jianlin Xu, Yongqi Wu, John Megill, Mike Borys, Glenn MacIssac, and Anurag Khetan (Abstract)

Effect of lactate media concentration on induced pluripotent stem cell proliferation and metabolism, Daniel Odenwelder and Sarah W. Harcum (Abstract)

Strategies to modulate charge variants of a Biosmilar monoclonal antibody through cell culture conditions, Prafulla M. Mahajan, Nareshbabu Sama, Narasimha Gowtham D.S, Sneha Kannan, Krishna Prasad Chellapilla, Suman Bandyopadhyay, C Nirmala Raju, and Sateesh Kumar Natarajan (Abstract)

Generating glycan variants for biological activity testing by means of parallel experimental design and multivariate analysis, David Bruehlmann, Martin Jordan, Michael Sokolov, Alessandro Butté, Abhijeet Satwekar, Alessandra D’Angelo, Jürgen Hemberger, Markus Sauer, Jonathan Souquet, and Hervé Broly (Abstract)

A systematic approach for process development and quality control in continuous perfusion cultures, Moritz Wolf and Massimo Morbidelli (Abstract)

Genotype of CHO host cell line has higher impact on mAb production and quality than process strategy or cell culture medium, Andreas Castan, David Reinhart, Lukas Damjanovic, Christian Kaisermayer, Wolfgang Sommeregger, Andreas Gili, Bernhard Gasslhuber, and Renate Kunert (Abstract)

Maintaining product quality from early to late stage process development, Jason C. Goodrick (Abstract)

Effects of cryopreservation on recombinant CHO cell lines, Inn Yuk (Abstract)

Improving glycosylation profiles and cell culture performance with a sensitive cell line in commercial manufacturing, Lisa L. Vulliet, Grant Sumida, Jun Luo, and Jesse Bergevin (Abstract)

Evaluation of Raman spectroscopy for online monitoring of cell culture product quality, Barbara Chiang, Brian Horvath, and Gordon Magill (Abstract)

Using PLS to understand potential sources of process variation & assessing medium components to alter afucosylation, Angela Meier, Jeremy Besmer, and Steve Meier (Abstract)

Comprehensive manipulation of glycosylation profiles across development scales, Sven Loebrich, Thomas Ryll, Kristina Ladd, and Seth Kitchener (Abstract)

Controlling fab terminal sialylation of antibodies through culture conditions, Calum McIntosh; Christopher Sellick,; Alison Mason; Bertie Chi; Karen Polizzi; and Cleo Kontoravdi (Abstract)

Elucidating amino acid metabolism in CHO cells, Michael J. Betenbaugh, Jaqueline E. Gonzalez, Brian O. McConnell, Harnish Mukesh Naik, Maciek R. Antoniewicz, and Venkata Gayatri Dhara (Abstract)

Towards a universal CHO reference platform with epigenome characterization for the biotechnology community, Michael Betenbaugh, Yiqun Chen, Harnish Mukesh Naik, Venkata Gayatri Dhara, Douglas Nmagu, Jongyoun Baik, Kelvin H. Lee, Sarah W. Harcum, Daniel C . Odenwelder, Seongkyu Yoon, Hemlata Bhatia, and Huolong Liu (Abstract)

Intact glycopeptide analysis of recombinant protein from CHO cells, Qiong Wang, Sandra Chough, Michael J. Betenbaugh, and Hui Zhang (Abstract)

Modulation of Mannose levels in N-linked glycosylation through cell culture process conditions in order to increase ADCC activity for an antibody Biosimilar, Shahid Rameez, Yogender Gowtham, Dustin Costello, Srivatsan Gopalakrishnan, Sigma Mostafa, and Abhinav Shukla (Abstract)

A highly automated, continuous method for developing active controllers of product quality attributes in early phase clinical development, Brandon Downey, John Schmitt, and Jeffrey Breit (Abstract)

Developing integrated platforms for the generation of cell lines expressing bispecific proteins with desired qualities, Jie Zhu, Lina Li, Judith Klover, Michael Handlogten, Tom Albanetti, Wai Keen Chung, Dengfeng Liu, Yariv Mazor, Diane Hatton, and Raghavan Venkat (Abstract)

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Impact of S-sulfocysteine on fragments and trisulfide bond linkages in monoclonal antibodies, Aline Zimmer, Ronja Seibel, Alisa Schnellbaecher, Susanne Bohl, Maria Wehsling, Sandra Maier, and Anne Zeck (Abstract and Presentation)

Process and raw material control strategies to manage variability in charge variant species of a monoclonal antibody, Vijay Janakiraman, A. Graham Tulloch, Peter Russo, Gargi Maheshwari, Jonathan Cacciatore, Ruben van Houts, and Jürgen van de Lagemaat (Abstract)

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Development of a platform expression system using targeted integration in Chinese Hamster Ovary cells, Scott Bahr, Trissa Borgschulte, Michael Johns, and Jeff Galligan (Abstract and Presentation)

Defining scalable cell culture processes for Biosimilar candidates, Carmen Ho, Anna Trimble, Jin Yin, and Claudia Gonzales (Abstract)

Dielectric monitoring of mammalian cells in a bioreactor, Michael Butler, Katrin Braasch, Elham Salimi, Douglas Thomson, and Gregory Bridges (Abstract)

HIV-1 envelope vaccine production with improved yields and glycosylation profile through mannose supplementation, J. Isaac Godfroy, Julia Frederick, Peifeng Chen, Joe Horwitz, Frank Arnold, and Elizabeth Carey (Abstract)

Control strategies for the regulation of protease clipping during mAb production in CHO cells, Daniel Blackstock, Peyi Runsewe, Wei Cheng, Frank Arnold, and Joe Horwitz (Abstract)

Regulation of recombinant protein expression during CHO pool selection enhances high producer frequency, Yves Durocher, Cécile Toussaint, and Olivier Henry (Abstract)

Novel engineered CHO DG44 host cell line demonstrates lowered UPR, increased titers and superior quality of recombinant vaccines, Hussain Dahodwala, Elizabeth Scheideman, Stephanie Golub, and Frank Arnold (Abstract)

Monitor and control of multiple bioreactor parameters using in situ raman spectroscopy, Michelle LaFond (Abstract)

Proteolysis of non-IgG molecules in transient HEK293 and stable CHO-K1 bioprocesses, Alfred M. Engel (Abstract)

Implementing automated pCO2 control in small scale cell culture models, Lia Tescione, Xiaoxia Jin, Woo Suk Ahn, Laura Greenfield, Jason Sherman, Katie Aldrich, Alissa Borshchenko, and Canghai Lu (Article)

Bioreactor scale down model case study: Ensuring nutrient feed strategy is representative of clinical and commercial scale, Matthew Leith, Bill McFee, John Valliere-Douglas, Aaron Chen, and Swapnil Bhargava (Abstract)

Controlling the product quality attributes of a complex recombinant protein in a high cell density perfusion bioreactor process, Rahul Chelikani (Abstract)

Controlling monoclonal antibody product quality using High Throughput Systems (HTS), Amlan Das, Mei-mei Lu, Namratha Kuloor, and Shyamsundar Subramanian (Abstract)

Comparison of transfection methods on yield of recombinant human IgG1 Fc, Evan Wells and Anne Robinson (Abstract)

Raman spectroscopic analysis of cell differentiation and death modes, James M. Piret, Shreyas Rangan, Stanislav O. Konorov, Sepehr Kamal, Ali Asadi, Timothy J. Kieffer, Michael W. Blades, and Robin F.B. Turner (Abstract)

Proteasome-based selection systems for generation of recombinant CHOK1SV GS- KO™ cell lines with enhanced productivity, Daniel Wan, Tanya Knight, Mark Smales, Sarah Turner, and Colin Jaques (Abstract)

Understanding the zinc induced lactate shift in CHO cell culture at transcriptomics level to improve the protein productionel to improve the protein production, Hemlata Bhatia and Seongkyu Yoon (Abstract)

Systems engineering N-glycans of recombinant therapeutic proteins, Meghan G. McCann, Christopher S. Stach, Tung Le, Nikunj Somia, Michael Smanski, Wei-Shou Hu, Xinning Chen, and Liang Zhao (Abstract)

Antibody charge heterogeneity formation in a mammalian cell culture fed-batch process, Bernhard Sissolak, Nico Lingg, Kulwant Kandra, Gerald Striedner, Karola Vorauer-Uhl, and Wolfgang Sommeregger (Abstract)

Evaluation of redox potential of the Golgi of CHO cells, Laura Palomares, Frania Zúñiga Bañuelos, Arturo Pimentel, and Octavio T. Ramírez (Abstract)

Use of biocapacitance probes for optimized process control at large-scale manufacturing, Christoffer Bro, Chris Kwiatkowski, and Anne Tolstrup (Abstract)

Online capacitance probes precisely control cell biomass growth through temperature regulation, Jeffrey Swanberg, Ricardo Lewis, Norman Riker, Kathryn Aron, Michael Borys, and Zhengjian Li (Abstract)

Evaluation of bioanalyzers for upstream commercial manufacturing, Pani Apostolidis, Brandon Raghobir, Tim Diehl, Eddie Crabbe, Ron Bates, and Ninad Patil (Abstract)

Boundary of oxidative and overflow metabolism (boom) controller for CHO cell feed control, Kathryn Elliott, Swadeel Gaad, Daniel C. Odenwelder, Marshall Trout, and Richard E. Groff (Abstract)

High-density Vero cell perfusion culture in BioBLU 5p Single-Use Vessels, Sebastian Selzer, Xiaofeng (Kevin) Han, and Ma Sha (Abstract)

High-throughput screening for best clone manufacturing using scale-down models, Maria Wendt, Christoph Freiberg, and Lukasz Gricman (Abstract)

Substrate kinetics screening method for mitigating low titer yields at large scale production, Beril Ereren, Fikret Kulenovic, Semsi Ensari, and Dave Stewart (Abstract)

Increasing efficiency in cell line development through automated workflows, David Shaw, Mandy Yim, Joni Tsukuda, Ali AlBarakat, and Daniel Tran (Abstract)

Improving transient gene expression in CHO-EBNA1 cells, Eric Grazzini, Sylvie Perret, Martine Pagé, Martin Loignon, Eric Grazzini, Yves Durocher, and Alina Burlacu (Abstract)

Novel downstream process and analytical tools developed for Influenza VLP vaccine, Patricia Alves, S.B. Carvalho, J.M. Freire, R. Silva, M.G. Moleirinho, B. Cunha, A.S. Moreira, F. Monteiro, D. Gaspar, M.A.R.B. Castanho, G.J.L. Bernardes, D. Wheatley, J. Welsh, R. Gantier, A. Xenopoulos, P. M. Alves, C. Peixoto, and M.J.T Carrondo (Abstract)

Use of the Cyto-Mine for rapid generation of high-producing clonal cell lines, Kevin D. Smith, Subinay Ganguly, and Thomas Kelly (Abstract)

Investigating the use of integrated analytics and automation to enhance process development capabilities, Melisa Carpio (Abstract)

Transcriptomic signatures classifying CHO quasispecies, Ankita Singh, Helene F. Kildegaard, Yuzhou Fan, and Mikael R. Andersen (Abstract)

Development of a CHO production medium utilizing proteomic and metabolomics analysis, Paul Gulde, James Smith, Jamie LaPierre, William Paul, Ryan Boniface, Anson Pierce, Paul Gulde, Andrew Campbell, and Nicole DiNardo (Abstract)

Rapid process monitoring & control in mammalian cell culture using off-gas mass spectrometry analysis, Hai-Yuan Goh, Ajoy Velayudhan, Michael Sulu, Graham Lewis, and Graham Josland (Abstract)

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Strategies to improve productivity of CHO-S cells expressing an anti-TNFα monoclonal antibody with biosimilar potential, Ana M. Moro, Matheus Luchese, Lilian Tsuruta, Wagner Quintilio, and Mariana Lopes dos Santos (Abstract and Presentation)

Getting more for less: Leveraging epigenetics to increase process yield, Chris Kwiatkowski, Joost Groot, Alan Gilbert, and Mark Tie (Abstract)

Product sieving challenges in TFF perfusion cell culture, Marcella Yu, Lisa Sawick, Henry Lin, Todd Luman, Jonathan Coffman, Scott Godfrey, Felipe Strefling, Hayden Tessman, and Daisie Ogawa (Abstract)

Dipeptides in cell culture - Tools for performance increase and risk reduction, Christian Kessler and Jessica Mueller-Albers (Abstract)

Mammalian cell perfusion cultures: “Intensification by growth inhibition”, Moritz Wolf and Massimo Morbidelli (Abstract)

Evaluation of IRES-mediated expression and different signal peptides for the development of CHO clones producing an anti-PCSK9 monoclonal antibody, Thayana Araujo da Cruz, Marcos B. Pinho, and Leda R. Castilho (Abstract)

Development of perfusion processes for mAb production aiming at high cell densities sustained by low cell-specific perfusion rates, Renata Alvim, Leda Castilho, Ioná W. Bettinardi, and Juvissan Aguedo (Abstract)

Platform based screening strategies that deliver reliable and high quality continous biomanufacturing processes, Leon Pybus; Tatsuya Matsuura; Yuya Watanabe; Takeshi Yamamoto; Christopher Knowles,; and Fay Saunders (Abstract)

Process intensification: Case study with a CHO-based monoclonal antibody production process, Isam A. Hararah, Robin Gruver, Kenneth Cunningham, Barbara Chiang, Brian Horvath, and Natarajan Vijayasankaran (Abstract)

Rapid and flexible scale-down media development and optimization for perfusion culture, James Kevin Y. Tan, Jenny Bang, Jessie Ni, and Catherine Nguyen (Abstract)

Development of a chemically defined medium for optimal growth and recombinant protein production in HEK293 cells, Chaya Kataru, Scott Eberhardy, and John F Menton (Abstract)

Implications of feeds and supplements on the productivity and quality of recombinant proteins produced in CHO cells, John F. Menton, Scott Eberhardy, Payel Maiti, Kyle Liu, and Chaya Kataru (Abstract)

Cellular behavior in high density perfusion processess, Delia Lyons, Joaquina Mascarenhas, Jana Mahadevan, and Jeremy Riesberg (Abstract)

Hybrid fed-batch cultures using XCell ATF for better yield and robust clarification process, Shashi Kudugunti, Jyoti Amatya, Craig Robinson, and Jamie Peyser (Abstract)

Evaluation of an n-1 perfusion/high-seed fed-batch technology for the intensification of recombinant protein production processes: From AMBR250 to 200 L STR, Daniel Vazquez Ramirez, Marc Hein, Norbert Schulze, Yali Zhang, and Oliver Krämer (Abstract)

Optimization and evaluation of perfusion media in high cell density mammalian cell culture systems, Christopher Brau, Yang Wang, Borka Naumovich, Steve Gorfien, and Andrew Campbell (Abstract)

Producer cell line engineering for large volume manufacturing of therapeutic Aav, Chapman Wright, Mark Tie, Adam D’Amato, Samantha Davis, and John Pieracci (Abstract)

Enhanced cell growth with physiologically relevant media supplements, Stephen Orzell, Lisa Karimi-Naser, and Alyssa Master (Abstract)

Generation of helper virus-free adeno-associated viral vector packaging/producer cell lines based on a human suspension cell line, Kerstin Hein, Silke Wissing, Nina Riebesehl, Nikola Strempel, Nicole Faust, and Martina Graßl (Abstract)

Bioprocess optimization for the expansion of early memory T cells in serum-free conditions, Ernesto Scibona, Maria Maddalena Perra, Luis Ayala Solares, and Massimo Morbidelli (Abstract)

Heterotypic cell-cell interaction of human stem cells for neural differentiation of hybrid spheroids, Liqing Song, Sébastien Sart, Teng Ma, Julie Bejoy, Xuegang Yuan, Yan Li, and Ang-Chen Tsai (Abstract)

Metabolic regulation of functional decline during in vitro expansion of human mesenchymal stem cells, Xuegang Yuan, Ang-Chen Tsai, Teng Ma, and Yijun Liu (Abstract)

Engineering culture environment of human pluripotent stem cells to direct their commitment and maturation towards functional cardiomyocytes: An “-Omics” driven approach, Margarida Serra, Paula M Alves, Patricia Duarte, Ana Teixeira, Cláudia Correia, Alexey Koshkin, Dongjian Hu, and David Elliott (Abstract)

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Scalable lentiviral vector production using stable producer cell lines in perfusion mode, Sven Ansorge, Aziza Manceur, Stéphane Lanthier, Sonia Tremblay, Anne-Marie Gélinas, July Dorion-Thibaudeau, Sophie Broussau, Julia Transfiguracion, Hafida Aomari, and Rénald Gilbert (Abstract and Presentation)

Quantitative characterization of all single amino acid variants of a viral capsid-based delivery vehicle, Danielle Tullman-Ercek, Matthew Francis, and Emily Hartman (Abstract)

Evaluating a gas-permeable culture surface for the generation of megakaryocytes for in-vitro platelet production, Andres Martinez and William M. Miller (Abstract)

Optimization of human T cell expansion ex vivo using serum-free medium and the gas- permeable rapid expansion cell culture devices (G-Rex), Evan R. Zynda, Sarya Mansour, and Pei-Yi Lin (Abstract)

Engineering of exosomes for targeted delivery of therapeutic microRNAs, Nadja Raab, Kerstin Otte, Nikolas Zeh, Benjamin Weis, Silke Wissing, and Nicole Faust (Abstract)

Megakaryocytic microparticles-mediated nucleic acid delivery for gene therapy, Chen-Yuan Kao and Eleftherios T Papoutsakis (Abstract)

CRISPR-Cas9 mediated cell line engineering of apoptosis pathways increases antibody expression with site-specific modifications for antibody drug conjugation, Yingchun Lu, Ivy Jiang, Alyssa Powell, Weimin Lin, Feng Tian, and Sigeng Chen (Abstract)

Challenges in cell culture platform development of mAb production with site-specific incorporation of non-natural amino acid for ADC generation, Weimin Lin, Yingchun Lu, Le You, Kellen Dragan, and Mark Shimazu (Abstract)

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Novel transposase tools for cell-line engineering, Ferenc Boldog, Jeremy Minshull, Mark Welch, and Kate Caves (Abstract and Presentation)