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The articles for these proceedings are not peer-reviewed

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Conference Program, Kathy Chan (Conference Proceeding)

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The renaissance of cancer immunotherapy is a revolution for patients, Ira Mellman (Abstract)

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Building quality novel formats and development processes, Steven Lang (Abstract)

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Engineering, expression screening, and production cell line development of hetero Ig molecules using charge pair mutations, Jennitte Stevens, Guna Kannan, and Trent Munro (Abstract)

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Bispecific antibodies: Strategies, considerations and challenges, Christoph Spiess (Abstract)

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A novel bispecific antibody for HER2+ breast cancer: The BEAT GBR 1302, Pierre Moretti, Julie Macoin, Amelie Croset, Darko Skregro, Romain Ollier, Stanislas Blein, Martin Bertschinger, Samuel Hou, and Jonathan Back (Abstract)

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Challenges developing biologics for the prevention and treatment of infectious diseases impacting global health, Steven Hadley (Abstract)

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Systems engineering of a CHO cell line for enhanced process robustness, Kyoungho Lee, Hsu-Yuan Fu, Liang Zhao, Lei Feng, Tung Le, Haiyun Pei, Sugandha Rajput, Dong Cho, Nikunj Somia, Scott McIvor, and Wei Hu (Abstract)

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Omics approach for generating a high-yield CHO cell line producing monoclonal antibodies, Wei Chi, Hsuan-Pu Chen, Dalton Chen, Hsin-Lin Lu, Bor-Shiun Chen, Chao Yi Teng, Chien-I Lin, Hsueh-Lin Lu, Chi-Chen Hsu, and Sheng Jie Huang (Abstract)

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Predictive engineering of CHO cells using systems biology models, Nathan Lewis (Abstract)

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Generation of desirable CHO cell factories with predictive culture performance using CRISPR/Cas9-mediated genome engineering, Helene Faustrup (Abstract)

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Effective microRNAs for cell line engineering and cellular mechanisms of action, Kerstin Otte, Albert Paul, Rene Handrick, Simon Fischer, and Verena Emmerling (Abstract)

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Developing the host for targeted integration cell line development, MIchelle Zhou, Isla Cheung, Shirley Yip, Mike Laird, John Joly, Brad Snedecor, Amy Shen, and Yongping Crawford (Abstract)

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Process optimization for semi-continuous virus production at high cell densities, Daniel Vazquez, Michael Pieler, Yvonne Genzel, Ingo Jordan, Volker Sandig, and Udo Reichl (Abstract)

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Evolution of an integrated continuous antibody manufacturing process, Christopher Kistler (Abstract)

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Overcoming process intensification challenges to deliver a manufacturable and competitive integrated continuous biomanufacturing platform, Jason Walther, Neha Shah, Myles Hollenbach, Jonathan Wang, Marcella Yu, Jiuyi Lu, Yang Yang, Konstantin Konstantinov, and Chris Hwang (Abstract)

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Cell-controlled high-intensity perfusion and hybrid fed-batch systems that drastically reduce perfusion rates and harmonize with continuous downstream processing, Gregory Hiller, Matthew Gagnon, Ana Maria Ovalle, Bhanu Chandra, Wenge Wang, and Elizabeth Eydelman (Abstract)

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Purification of a hepatitis C vaccine candidate: Comparison between multi- column chromatographic processes operated in positive and negative mode, Ricardo Silva, Alex Xenopoulos, Paula Alves, Manuel Carrondo, and Cristina Peixoto (Abstract)

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Life in the fast lane: Developing and commercializing KEYTRUDA®, a novel breakthrough therapy designation oncology therapy, in three years from first patient dosed to US approval, Gargi Maheshwaru, Athena Nagi, Ronald Smulders, Fergal O´Donovan, Kimberly May, Tamas Blandi, and Marc Bastiaansen (Abstract)

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To clone or not to clone? – Wrong question! An investigation on genome heterogeneity and stability and on what controls cell behavior, Nicole Borth (Abstract)

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Targeted sequencing for comprehensive genetic characterization of a recombinant CHO cell line, Brian Mickus (Abstract)

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Polysorbate 20 and 80 degradation by Group XV lysosomal phospholipase A2 Isomer X1 in monoclonal antibody formulations, Troii Hall, Stephanie Sandefur, Christopher Frye, and Lihua Huang (Abstract)

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Genetic engineering of MMV virus resistance into CHO cells: Probing the role of various CHO sialyltransferases in virus binding and internalization, Kevin Kayser, Joaquina Mascarenhas, Trissa Borgschulte, and David Onions (Abstract)

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Implementation of a recirculating TFF N-1 perfusion system at manufacturing scale: Conquering process hurdles and scaling challenges, Alex Doane, Weiwei Hu, William Yang, Kelly Wiltberger, and Haofan Peng (Abstract)

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Seamless scalability, consistency and quality of transient protein production in CHO Cells by using MaxCyte flow electroporation technology, Weili Wang, Rama Shivakumar, Pachai Natarajan, Angelia VIley, Madhusudan Peshwa, and James Brady (Abstract)

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A carbon dioxide stripping model for mammalian cell culture in manufacturing scale bioreactors, Zizhuo Xing, Nicholas Abuabsi, Michael Borys, and Zheng Jian (Abstract)

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Scale-up and scale-down challenges for a high density long-term perfusion suspension cell culture in large-scale single use bioreactors, Weichang Zhou and Hang Zhou (Abstract)

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Bioanalytical comparability of biotechnology products subject to changes in their manufacturing process, Jose Menezes, Maria Campos, and Pedro Felizardo (Abstract)

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The potential of small molecules to modulate glycosylation by media design, David Bruehlmann (Abstract)

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Factors affecting the sialylation of Fc- fusion protein in recombinant CHO cell culture, Gyun Min Lee (Abstract)

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Optimization of glycosylation and charge distribution through culture parameters and supplements, Sigma Mostafa, Ventaka Tayi, Shahid Rameez, Nathan Oien, Jaspreet Notey, Brian Baker, Jimmy Smedley, and Abhinav Shukla (Abstract)

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Identification of cell culture levers to lower trisulfide modifications in monoclonal antibodies produced in CHO cell culture, Masaru Shiratori, Jessica Wuu, and Martin Gawlitzek (Abstract)

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From observation to control: Using cell culture automation for enhanced product quality optimization, Sven Markert (Abstract)

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Cell culture engineering and biosimilars: The physician’s perspective, Jan Hillson (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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Systems Analysis of CHO cell metabolism for enhanced fed-batch process performance: Identification of novel growth inhibitors and their control, Bhanu Chandra, Jaitahree Kale, AnaMaria Ovalle, and Gregory Hiller (Abstract)

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3D tumor models with defined cellular and physico- chemical components: Impact of recapitulative tumor microenvironment on disease progression, Catarina Brito, Vitor Santo, Marta Estrada, Sofia Rebelo, Elizabeth Anderson, Wolfgang Sommergruber, Erwin Boghaert, and Paula Alves (Abstract)

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Poly-pathway model approach: Simulation of multiple metabolic states, Erika Hagrot, Hildur Oddsdottir, Anders Forsgren, and Veronique Chotteau (Abstract)

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

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Application of multivariate data analysis in the monitoring and control of mammalian cell processes, Stephen Goldrick, Richard Turner, Marcel Kuiper, Kenneth Lee, Rahul Pradhan, and Suzanne Farid (Abstract)

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Implementation of Raman spectroscopy at manufacturing scale: Overcoming modeling challenges while implementing advanced process control, John Smelko, Thomas Matthews, Brandon Berry, and Douglas Osborne (Abstract)

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Application of 13C flux analysis to identify high-productivity CHO metabolic phenotypes, Jamey Young (Abstract)

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Understanding and controlling sialyation in a CHO fusion protein at lab and manufacturing scale using targeted omics techniques, Amanda Lewis, Nelly Aranibar, William Croughan, Nicholas Abu-Absi, Bethanne Warrack, Michael Borys, Michael Reily, and Zheng Jian Li (Abstract)

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Targeting product quality: Where systems biotechnology and process design meet, Markus Michael Muller, Jan Bechmann, Ingo Gorr, Harald Bradl, and Jan Visser (Abstract)

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Fluxomics: The integration of metabolic flux analysis (MFA) with multivariate data analysis (MVDA) to identify key process parameters for CHO cell culture, Neil Templeton (Abstract)

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Biotherapeutic development in the 'Omics Age: The CHO genome and beyond, Chapman Wright, Joost Groot, and Scott Estes (Abstract)

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Mammalian systems biotechnology: An integrative framework for combining in silico modeling and multi-Omics datasets in different CHO parental cell lines, Dong Yup Lee, Sarantos Kyriakopoulos, Meiyappan Lakshmanan, Kok Siong Ang, Alison Lee, Xuezhi Bi, Andy Tan, Ying Swan Ho, Peiqing Zhang, Yuansheng Yang, and Say Kong Ng (Abstract)

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NEXT GEN CAR T CELLS, Michael Jensen (Abstract)

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Agitation strategies for the culture and detachment of human mesenchymal stem cells (hMSCs) from microcarriers in multiple bioreactor platforms, Alvin Nienow (Abstract)

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Cell-derived microparticles for cell therapy, cargo delivery, and applications in CHO-cell biotechnology, Terry Papoutsakis, Jinlin Jiang, and Chen-YUan Kao (Abstract)

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Intracellular characterization of Gag-GFP VLP production upon PEImediated transient transfection of HEK 293 cells, Laura Cervera, Irene Gonzalez Dominguez, Mercedes Segura, and Francesc Godia (Abstract)

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Industrialization of adenoviral vector production in fixed bed bioreactor and amplification of primary liver cells in Xpansion® bioreactor: Autologous insulin producing cells for the treatment of diabetes, from bench to clinical scale, Rachel Legmann (Abstract)

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A quality by design (QbD) approach to cell culture process characterization, Melissa Mun (Abstract)

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Michael Borys (Bristol- Myers Squibb) Incorporation of QbD elements into the development and characterization of a second generation process, Michael Borys and Nicholas Abu-Absi (Abstract)

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Development of a process analytical technology (PAT) infrastructure for future biologics upstream processing, Mathieu Steefland (Abstract)

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Use of quality by design principles for development of upstream process control strategy, Canghai Lu and Girish Pendse (Abstract)

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Automated, high throughput imaging during cell line development to increase the assurance of clonality, David Shaw (Abstract)

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Establishing a robust two-step cloning strategy for the generation of cell lines with a high probability of monoclonality, Alison Young, Claire Lovelady, Mahesh Shivare, Jarka Glassey, Shirley Coleman, and Alison Porter (Abstract)

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Proof that can travel - documented clonality report for regulatory submission, Ian Taylor and Paul Miller (Abstract)

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Insight into single cell cloning in serum-free media, Tsuyoshi Yamaguchi, Yumi Sugita, Mie Fukuda, Keina Yamaguchi, Yuka Mashio, Koichi Yamamoto, and Toshiyuki Suzawa (Abstract)

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Karyotype-based analysis of cell line instability and clonality in CHO cells, Jong Youn Baik and Kelvin Lee (Abstract)

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Assessment of genomic instability in Chinese Hamster ovary (CHO) cells, Sabine Vcelar, Martina Baumann, Michael Melcher, and Nicole Borth (Abstract)

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Identifying low-Level sequence variants via next generation sequencing to aid stable CHO cell line screening, Sheng Zhang, Dean Regier, David Oullette, Ivan Correia, and Jerry Carson (Abstract)

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Time course of transcription and chromatin states during batch culture in Chinese Hamster ovary cells, Inmaculada Hernandez (Abstract)

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Prediction of stable and transient expression of recombinant proteins from CHO cells based upon translational reprogramming, Charlotte Godfrey (Abstract)

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Generation of a stable pluripotent cell line from Chinese Hamster embryonic fibroblasts, Haiyun Pei and Dong Seong Cho (Abstract)

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Microfluidic accelerated evaluation of CHO cell clones by perfusion of fed-batch conditioned media, Darek Sikorski (Abstract)

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Genome-wide RNAi screen for improved functional expression of recombinant proteins from HEK 293 cells, Joseph Shiloach (Abstract)

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Bridging the gap of screening and scale up in CHO, hybridoma, HEK293 and other cell lines: Single use optimum growth flasks 30mL-5L flasks with transfer caps, and ports, Sam Ellis (Abstract)

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Sub-physiological culture temperature boosts expression levels of membrane proteins in CHO cells, Sampath Kumar, Lihui Zhong, Beata Bobrowicz, and Juergen Nett (Abstract)

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Varied productivity according to the differences between targeted locations of antibody expression vectors in Chinese Hamster ovary cells, Noriko Yamano, Jana Frank, Masayoshi Onitsuka, and Kota Yoshitomi (Abstract)

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Targeted integration of multiple active sites in CHO genome for rapid generation of stable and high monoclonal antibody producing cell lines, Yuansheng Yang (Abstract)

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Identifying opportunities in cell engineering for the production of ‘difficult to express’ recombinant proteins, HIrra Hussain, Alan Dickson, Mark Abbott, Robert Roth, and David Fisher (Abstract)

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CHO-K1 host cell engineering strategy enabling the establishment of strains producing higher yields of recycling antibodies, Hisahiro Tabuchi, Ikumi Murakami, and Masaki Yamaguchi (Abstract)

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Flow cytometry screening strategy for the enrichment of high-producing Chinese Hamster ovary cells for monoclonal antibody manufacturing, Takeshi Okumura (Abstract)

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Reduction of metabolic waste products, ammonia and lactate, through the coupling of GS selection and LDH-A down-regulation in CHO cells, Soo Min Noh, Jin Hyoung Park, and Gyun Min Lee (Abstract)

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Cre-loxP-controlled cell-cycle checkpoint engineering in Chinese Hamster ovary cells, Takeshi Omasa, Rima Matsuyama, Tomomi Tsusui, Noriko Tamano, Masayoshi Onitsuka, and Kyoung Lee (Abstract)

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Expression of glycoproteins with excellent pharmacokinetic properties on the novel CAP-Go expression platform, Silke Wissing (Abstract)

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An integrated cell line development platform for generation of high yielding CHO stable cell lines expressing a stabilized trimeric pre-fusion RSV F recombinant viral glycoprotein, Richard Schwartz, Amritha Menon, Mingzhong Chen, Giulia Fabozzi, and Althaf Hussain (Abstract)

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Development of hyper osmotic resistant CHO host cells, Yauharu Kamachi (Abstract)

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Genetic engineering of CHO cells for viral resistance to MMV: Targeting virus binding, internalization, intracellular trafficking and transport to nucleus, Joaquina Mascarenhas (Abstract)

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Accelerated homology-directed targeted integration of transgenes in CHO cells via CRISPR/Cas9 and fluorescent enrichment, Jae Seong Lee, Lise Marie Grav, Gyun Min Lee, and Helene Kildegaard (Abstract)

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CRISPR-CAS9 knockout library for CHO, Lasse Ebdrup, Alex Thomas, Hooman Hefzi, Philipp Spahn, Kaen Karottki, Helene Kildegaard, and Nathan Lewis (Abstract)

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Glycoengineering of Chinese Hamster ovary cell for modulating glycoprotein Nlinked sialylation, Chengyu Chung (Abstract)

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Re-programming CHO cell metabolism using miR-23 tips the balance towards a highly productive phenotype, Niali Barron (Abstract)

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A novel platform for high throughput cell line screening & development, Maria Wendt, Christoph Freiberg, Cristopher Smith, and Hans Fischer (Abstract)

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Cell Express 100TM - A robust, simple and cost effective alternative to highthroughput automated platforms for cell line development, Raj Kumar Kunaparaju (Abstract)

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Changes in product quality – what is comparable “enough” and what is “similar enough?”, David Robinson (Abstract)

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Improving the productivity and product quality of antibodies expressed from a CHO transient system, Athena Wong (Abstract)

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A systematic development approach to optimize and control biopharmaceutical product quality, Min Zhang, Leisha Youngblood, Carrie Weymer, Gian Arias, and Tim Hill (Abstract)

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Strategies for optimizing a cell culture platform to achieve high recombinant protein titer without impacting product quality, Natarajan Vijayasankaran, Robin Gruver, and Steven Meier (Abstract)

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Impact of harvest conditions on the glycosylation profile of a therapeutic antibody, Raghavan Venkat (Abstract)

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Investigating the impact of process optimization on productivity, product quality, cell metabolism, and intracellular environment, Shailendra Singh (Abstract)

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Enhancing enveloped viral particles production by targeted supplementation design: Releasing bottlenecks in IC-BEVS, Francisca Monteiro (Abstract)

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Efforts to reduce impact of media variability on product quality for a commercial perfusion process, Nirel Rillera, Kevin Yeh, Benjamin Youn, Jerome Acuna, John Henstrand, and Sean Forestell (Abstract)

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Bioreactor perfusion via single-use centrifugation has fewer product quality implications than tangential flow filtration, Rustin Shenkman, Douglas Gunzelmann, Ting Yang, Matthew Traylor, and Kenneth Manning (Abstract)

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Impact of culture conditions and cell age on sequence variant levels in monoclonal antibody biotherapeutics, Karin Anderson (Abstract)

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Evaluation of product antibody (mAb) heterogeneity in non-clonal cell pools for early pre-clinical development, Gabi Tremml (Abstract)

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A biphasic cultivation strategy to optimize protein expression and minimize aggregation of the final product, Andreas Gili (Abstract)

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Adjusting product quality attributes of a biosimilar using process levers, Brett Belognia (Abstract)