January 15-19, 2017
Hyatt Regency Mission Bay Hotel
San Diego, USA

Editors:   Tom Brieva, Celgene Cellular Therapeutics, USA
  William Miller, Northwestern University, USA
  Chris Mason, University College London, United Kingdom



Conference Program, Tom Brieva, William Miller, and Chris Mason (Article)

Shear susceptibility of human mesenchymal stem cells increases with generation number: Implications for stem cell therapy scale-up and manufacturing, Peter Amaya, Eric Plencner, James Kim, Will Heydinger, Jeffrey Chalmers, Peter Rapiejko, and Jane Ring (Abstract)

MaxCyte scalable electroporation: A universal cell engineering platform for development of cell-based medicines from R&D to clinic, Jessica McClure-Kuhar, Joseph Abad, Linhong Li, Pachai Natarajan, Madhusudan Peshwa, Jessica Carmen, and Krista Steger (Abstract)

Effects of culture media and suspension expansion technologies in mesenchymal stem cell manufacturing - A computational bioprocess and bioeconomics study, Carlos A.V. Rodrigues, Cátia Bandeiras, Joaquim M.S. Cabral, Frederico C. Ferreira, and Stan N. Finkelstein (Abstract)

Optimization of human limbal epithelial stem cell expansion under chemically defined culture conditions, Mario Antonio Tellez-Gonzalez, Juan Antonio Suárez-Cuenca, and Paul Mondragón-Terán (Abstract)


Modification of T lymphocytes with lentiviral vectors for expression of anti-CD19 chimeric antigen receptor (CAR), Virgínia Picanço-Castro, Pablo Moço, Daianne MC Fantacini, Marcela CC Freitas, Dimas T. Covas, and Kamilla Swiech (Abstract and Presentation)

Expansion strategies for human mesenchymal stromal cells cultured under xeno-free conditions, Kamilla Swiech, Patrícia Aparecida Tozetti, Samia Rigotto Caruso, Amanda Mizukami, Taisa Risque Fernandes, Maristela Delgado Orellana Hemotherapy, and São Paulo (Abstract)

Experimental and economic evaluation of different culture systems for mesenchymal stromal/stem cell expansion for clinical applications, Kamilla A. Swiech, Amanda Mizukami, Tania D. Pereira Chilima, Maristela D. Orellana, Dimas T. Covas, and Suzanne S. Farid (Abstract)

Directed differentiation of inner ear hair cells from mouse embryonic stem cells (E14Tg2a), Miguel Ángel Juárez Mancera, Paul Mondragón Terán, Juan Antonio Suárez-Cuenca, and Rafael Manuel Navarro-Meneses (Abstract)

Derivation of endothelial cells and formation of microvasculature from mouse embryonic stem cells, Alan Jesús Gómez-Calderon, Juan Antonio Suárez-Cuenca, and Paul Mondragón-Teran (Abstract)

Development of an alternative harvesting method using pH to detach adherent cells from microcarriers, Tylor Walsh, Jeff Biernaskie, Rajiv Midha, and Michael S. Kallos (Abstract)

Dissolvable microcarriers for efficient cell production and recovery, Todd Sciortino, Jennifer Weber, Jeffrey Scibek, and Martial Hervy (Abstract)

Aggregation kinetics of human mesenchymal stem cells under wave motion, Teng Ma, Ang-Chen Tsai, Yijun Liu, and Ravindran Chella (Abstract)

A method for estimating capital investment and facility footprint of cell therapy facilities, Tania Pereira Chilima, Thierry Bovy, Fabien Moncaubeig, and Suzanne S. Farid (Abstract)

NIST and FDA collaboration on standards development activities and laboratory programs supporting translation of regenerative medicine products, Sumona Sarkar and Sheng Lin-Gibson (Abstract)

High density culture of human induced pluripotent stem cells through the refinement of medium by dialysis in suspension, Suman Chandra Nath and Masahiro Kino-oka (Abstract)

Application of the migratory nature of human mesenchymal stem cells to optimise microcarrier-based expansion processes, Steven Ruck, Karen Coopman, Chris Hewitt, and Alvin Nienow (Abstract)

An alternative methodology for a quantitative flow-based cell-mediated in vitro cytotoxicity assay to evaluate immune cell potency, Sherry Zhou, Ryan Shorr, and Brian Murphy (Abstract)

Development of a cost efficient platform for the industrial manufacturing of pluripotent stem cell derived products for cell therapy: Cell expansion is the starting point, Jahid Hassan, Ricardo Baptista, Rhys Macown, Marc-Olivier Baradez, Beata Surmacz-Cordle, Daria Popova, Celine Martin, Ilaria Schena, Evangelia Rologi, Isabel Uwagboe, Mark Bell, Nicole Nicholas, Shai Senderovich, Garikai Kushinga, Nishanthi Weeratunge, Julie Kerby, Damian Marshall, Sarah Callens, and Stephen Ward (Abstract)

Scalable and controlled presentation of surface immobilised factors from the bone marrow niche for hematopoietic cell expansion, Rebecca Moore, Katie Glen, Matthew Worrallo, and Robert Thomas (Abstract)

Albumin in cell culture media – An examination of quality and function, Randall W. Alfano (Abstract)

Determination of an optimal formulation for CAR-T Cells: Cryopreservation studies using model T-Cells, Rachel Witts, Michael Tennant, Ken Chrobak, and Parag Kolhe (Abstract)

Investigating the requirement for dual cell co-culture platforms in creating regenerative cell therapies for CNS injury, Rachael Wood, Melanie Georgiou, and Ivan Wall (Abstract)

Experimental and Computational Fluid Dynamics study of microcarrier suspension during the cultivation of Mesenchymal Stem Cells in an ambr250 bioreactor, Qasim A. Rafiq, Marco C. Rotondi, Alvin W. Nienow, Christopher J. Hewitt, Neil Bargh, John Betts, and Ngibuini Mwai (Abstract)

Process development of human mesenchymal stem cell microcarrier culture using an automated high-throughput microbioreactor, Qasim A. Rafiq, Alvin W. Nienow, and Christopher J. Hewitt (Abstract)

Application of quality by design concepts and automation to improve manufacturing process consistency of development and clinical-stage cell therapies, Peter Mitchell, Mark McCall, Robert Thomas, and Kieran O’ Donovan (Abstract)

Control of starting material and final product administration of cellular therapies, Nayyereh Rajaei, Brian Murphy, Tom Brieva, and Greg Russotti (Abstract)

Economic and operational appraisal of an allogeneic CAR T-cell bioprocess, Michael Jenkins, Mark W. Leonard, Yajin Ni, Ronald W. Fedechko, and Suzanne S. Farid (Abstract)

Designing a banking scale of human induced pluripotent stem cells based on suspension time-dependent quality variations in filling and cryopreservation processes, Masashi Kagihiro, Kazuhiro Fukumori, Takuya Aoki, and Masahiro Kino-oka (Abstract)

The development of scalable bioreactor series for human iPS cell stirred suspension culture, Masanori Wada, Yoichi Ishikawa, Katsuhisa Matsuura, and Masahiro Kino-oka (Abstract)

Comprehensive cell manufacturing system based on flexible modular platform 85, Masahiro Kino-oka and Manabu Mizutani (Abstract)

Impact of the hydrodynamic environment on cardiomyocyte differentiation of iPSC, Martina Micheletti, Jasmin Samaras, Andrea Ducci, Claudia Correia, Paula Alves, and Margarida Serra (Abstract)

Scaling up a chemically-defined aggregate-based suspension culture system for neural commitment of human pluripotent stem cells, M. Margarida Diogo, Cláudia C. Miranda, Tiago G. Fernandes, and Joaquim M.S. Cabral (Abstract)

Development and optimization of animal origin-free, serum-free media for human treg manufacturing, M.A. Torres-Castillo, K. Bernstroem, T. Aarvak, and A. Varela-Rohena (Abstract)

Improving production and maturation of cardiomyocytes derivedfrom human pluripotent stem cells: An “-Omics” driven approach, Margarida Serra, Cláudia Correia, Alexey Koshkin, Patrícia Duarte, Ana Teixeira, and Paula M. Alves (Abstract)

Effective hypothermic storage of human pluripotent stem cell-derived cardiomyocytes compatible with global distribution of cells for clinical applications and toxicology testing, Margarida Serra, Cláudia Correia, Alexey Koshkin, Madalena Carido, and Paula M. Alves (Abstract)

Unveiling human Cardiac Stem Cells regenerative potential in Ishemia/Reperfusion Injury, Margarida Serra, Maria João Carvalho Sebastião, Rute Pereira, Patrícia Gomes-Alves, Paula Marques Alves, and Itziar Palacios (Abstract)

Characterization and fractionation in Aqueous Two-Phase Systems of site-specific PEGylated antibodies: Targeting stem cell separation, Marco Rito-Palomares and Mirna González-González (Abstract)

Establishing the design space of a filtration-based operation for the concentration of human pluripotent stem cells, Manuel JT Carrondo, Bárbara Cunha, Ricardo J.S. Silva, Cláudia Correia, Alexey Koshkin, Paula M. Alves, Margarida Serra, and Cristina Peixoto (Abstract)

Rapid human T cell expansion using gas-permeable bags in the Eppendorf New BrunswickTM S41i CO2 incubator shaker, Ma Sha, Amanda Suttle, and Stacey Willard (Abstract)


Opportunities for applying biomedical production and manufacturing methods to the development of the clean meat industry, Liz Specht and Christie Lagally (Abstract and Presentation)

Industrially-relevant examples using a data analytics strategy to effectively address complex performance challenges, Lisa Graham (Abstract)

Assay automation towards the commercialization of cell therapies, Kruti Shah (Abstract)

TRPV-1 activation through thermal and agonist treatment in the process of scalable cardiac differentiation and tissues fabrication is the novel strategy to eliminate undifferentiated iPS cells in the bioengineered cardiac tissues, Katsuhisa Matsuura (Abstract)

A mechanistic model of erythroblast growth inhibition: Optimising red blood cell manufacture, Katie Glen, Forhad Ahmed, Rachel Bayley, Robert Thomas, and Adrian Stacey (Abstract)

Development of microchannel emulsification as a novel cell encapsulation technology, Karen Markwick and Corinne Hoesli (Abstract)

Manufacturing solutions for robust cell therapy expansion and harvest, Sandhya Punreddy, Julie Murrell, Samantha Luther, Tristan Lawson, Aletta Schnitzler, and Martha Rook (Abstract)

Improving production of retroviral vector from Pg13 cells for T cell therapy, Joseph Shiloach, Sarah Inwood, Michael Betenbaugh, and Steve Feldman (Abstract)

Economics and quality attributes of hMSC production in xeno-free bioprocessing media, Jon A. Rowley, Lye Theng Lock, and Iain K. Farrance (Abstract)

Development of downstream processing options for the commercial scale purification of stem cell derived exosomes, Ivano Colao, Randolph Corteling, Daniel Bracewell, and Ivan Wall (Abstract)

Optimized process for regulatory T cell activation and expansion using Dynabeads™ Treg CD3/CD28 for clinical applications, Hui Zhang, Kerstin Bernstrom, Nora Lieske, Ida Caroline Schroder, Tuva Holt Hereng, Grethe Okern, Hilde Almaasbak, and Tanja Aarvak (Abstract)

Large-scale stem cell production system by newly designed bioreactor, Hideaki Kagawa, Shun Goto, Mika Mifune, Soichi Kohashi, Tetsuya Yoshida, and Hidekazu Yamazaki (Abstract)

Appraisal of microcarrier suspension dynamics in shaken bioreactors, Gregorio Rodriguez, Martina Micheletti, and Andrea Ducci (Abstract)

Maintenance of stemness and optimization of differentiation potentials during in vitro expansion of human adipose-derived stem cells, EunAh Lee, Jungsun Lee, and Tongin Oh (Abstract)

Scaled-up expansion of equine cord blood mesenchymal stem cells (MSCs) from stirred suspension bioreactors to 100mL computer controlled stirred suspension bioreactors using computational fluid dynamic modeling, Erin Roberts, Tylor Walsh, Thomas G. Koch, and Michael S. Kallos (Abstract)

Optimized media and workflow for the expansion of human pluripotent stem cells as aggregates in suspension, Eric Jervis, Angela McLaughlin, Kyle Hukezalie, Steven Woodside, Terry E. Thomas, Sharon A. Louis, and Allen C. Eaves (Abstract)

Enabling human pluripotent stem cell derived megakaryocyte, Elizabeth Cheeseman, Katie Glen Loughborough University, Rebecca Moore, Mark McCall, Robert Thomas, Thomas Moreau, Cedric Ghevaert, and Adrian Stacey (Abstract)

Optimization of a scalable single-use manufacturing platform for expansion of high quality human mesenchymal stem cells, Dave Splan, Mark Szczypka, Lye-Theng Lock, and Jon Rowley (Abstract)

Impact of high extracellular lactate on induced pluripotent stem cell metabolism and pluripotency, Daniel C. Odenwelder and Sarah W. Harcum (Abstract)

Development of a scale-down approach to the scalable culture of induced Pluripotent Stem Cells on microcarriers using single-use Vertical-Wheel™ bioreactors under xeno-free conditions, Carlos A.V. Rodrigues, Tiago G. Fernandes, Maria Margarida Diogo, Joaquim M.S. Cabral, Daniel Giroux, Yas Hashimura, Robin Wesselschmidt, and Brian Lee (Abstract)

New paradigm of scalable manufacturing for allogeneic cell therapy products, Brian Lee, Yas Hashimura, Seda Karamil, Francisco Rosello, Kenny Cruz, Nathan Starkweather, Robin Wesselschmidt, and Mattew Croughan (Abstract)

Computational fluid dynamic modeling of 100ml and scaled-down 10ml stirred suspension bioreactors enables prediction of embryonic stem cell characteristics, Breanna S. Borys, An Le, Michael S. Kallos, Charlie Yu-Ming Hsu, Derrick E. Rancourt, and Ian D. Gates (Abstract)

Expansion of 3D human induced pluripotent stem cell aggregates in bioreactors: Bioprocess intensification and scaling-up approaches, Bernardo Abecasis, Tiago Aguiar, Émilie Arnault, Rita Costa, Patricia Gomes-Alves, Anders Aspegren, Margarida Serra, and Paula M. Alves (Abstract)

Enginnering cardiac tissue using human induced pluripotent stem cell derivatives: Proteomic characterization of co-cultures of cardiomyocytes and endothelial cells, Bernardo Abecasis, Susana Rosa, Pedro Gouveia, Patricia Gomes-Alves, Margarida Serra, Lino Ferreira, and Paula M. Alves (Abstract)

A novel acoustic cell processing platform for cell concentration and washing, Bart Lipkens, Chris Leidel, Jason Dionne, and Brian Dutra (Abstract)

Characterisation and process verification studies in a miniature bioreactor used as a predictive tool to scale-up an industrial process, Asma Ahmad, Martina Micheletti, Eli Keshavarz-Moore, Richard Davies, and Geoff Brown (Abstract)

Development of a chemically defined, animal-component-free ex vivo expansion process for activated human T cells, Annie Ngo and Jessie H. –T. Ni (Abstract)

Characterization of a 3D matrix bioreactor for scaled production of human mesenchymal stem cells, Andrew B. Burns, Corinna Doris, Kevin Vehar, Cameron Bardliving, M. Ian Phillips, and Parviz Shamlou (Abstract)

Microfluidic tools and high-content imaging for cell therapy bioprocessing, Ana Valinhas and Ivan Wall (Abstract)

Umbilical cord matrix derived-mesenchymal stem cell production in microcarrier- based culture systems, Ana Fernandes-Platzgummer, António M. de Soure, Yi-Feng Huang, William Milligan, Amanda Mizukami, Kamilla Swiech, Cláudia L. da Silva, and Joaquim M.S. Cabral (Abstract)

Scale-out of massively parallel patient-specific cell cultures with a modified transportable conditioned cell culture chamber, Alicia D. Henn, Kayla Nolan, Shannon Darou, and Randy Yerden (Abstract)

Process development approaches for expansion of adherent stem cells in microcarrier-based bioreactor culture, Kara Levine, Aletta Schnitzler, Samantha Luther, Tiffany Hood, Tristan Lawson, Manjula Aysola, Kara Der, Julie Murrell, and Martha Rook (Abstract)

CAR-T manufacturing: delivering on the promise of a transformational therapy, Greg Russotti (Abstract)

Cell Therapy Manufacturing: It's about "TIME", Donald Powers (Abstract)

A penny today or a dollar tomorrow – early stage development for future success, Nick Timmins (Abstract)

How to use computational fluid dynamics in the development of cell therapeutics ?, Valentin Jossen, Regine Eibl, and Dieter Eibl (Abstract)

Dynamic mechanistic modelling and controlled growth factor delivery for optimization of scalable haematopoietic cell processing, Robert Thomas, Katie Glen, Rebecca Moore, Matthew Worrallo, Elizabeth Cheeseman, and Adrian Stacey (Abstract)

Utilizing simulation and optimization techniques to evaluate different CAR T cell therapy manufacturing paradigms, Jon C. Gunther, Olga Raskina, and Christopher G. Ramsborg (Abstract)

Decision support tools for cost-effective bioprocess design in the cell therapy sector, Michael Jenkins, Ronald W. Fedechko, Sa V. Ho, and Suzanne S. Farid (Abstract)

Engineering stem cell fate for drug development and therapy, Peter Zandstra and Guy Sauvageau (Abstract)

Bioprocess integration for human mesenchymal stem cells: from up to downstream processing scale-up to cell proteome characterization, Margarida Serra, Bárbara Cunha, Tiago Aguiar, Sofia B. Carvalho, Marta M. Silva, Ricardo A. Gomes, Manuel J. T. Carrondo, Patrícia Gomes-Alves, Cristina Peixoto, and Paula M. Alves (Abstract)

Process and equipment scale-up of controlled-rate freezing in cell therapy, Jonathan Rubin (Abstract)

Interactive visualization of cell expansion process performance, Toon Lambrechts, Maarten Sonnaert, Jan Schrooten, Frank P. Luyten, Jean-Marie Aerts, and Ioannis Papantoniou (Abstract)

High Density Ex Vivo Expansion Of Stem Cell Aggregates In Stirred Perfusion Bioreactors, Ernesto Scibona, Daniel Karst, and Massimo Morbidelli (Abstract)

Characterization And Optimization Of The Nanobridge System For Hesc Suspension Cultures, Peter Gray (Abstract)

Clinical Scale Manufacturing Of Autologous Insulin Producing Liver Cells For The Treatment Of Diabetes, Rachel Legmann, Andy Reniers, Nicholas Kohlstrom, Brian Gardell, Fabien Moncaubeig, Vered Aviv, Keren Shternhall-Ron, Irit Meivar-Levy, and Sarah Ferber (Abstract)

Process Scale-Up And Characterization For A Cardiac Derived Cell Therapy, Rachel Smith (Abstract)

Metabolomics And The Role Of Metabolism In Stem Cell Bioprocessing, Athanasios (Sakis) Mantalaris (Abstract)

Exosomes For Regenerative Medicine – Manufacturing Challenges And Potential Applications, Ivan Wall (Abstract)

Altering, Improving, And Defining The Specificities Of Crispr-Cas Nucleases, Benjamin P. Kleinstiver, Michelle S. Prew, Nhu T. Nguyen, Moira M. Welch, J. Keith Joung, Shengdar Q. Tsai, Vikram Pattanayak, and Martin J. Aryee (Abstract)

Challenges And Solutions To Quality Gmp Supply Of Aav Vectors, Anandita Seth and Francesca Vitelli (Abstract)


Gene Therapy For Inherited Blood Diseases, From Viral Vectors To Gene Editing, Fulvio Mavilio (Abstract and Presentation)

Cost-Effective Manufacturing Strategies For Feasible Commercialisation Of Autologous Car T-Cell Products, Tania Pereira Chilima, Thierry Bovy, Fabien Moncaubeig, and Suzanne S. Farid (Abstract)

Considerations And Challenges Associated With Manufacturing Autologous Cellular Therapies Such As Car T Cells, Dawn Maier (Abstract)

Removal Of Myeloid Cells From Autologous Leukocytes Used For Chimeric Antigen Receptor (Car) T Cell Manufacturing Improves Final Product Consistency And Yields, David Stroncek, Daniel W. Lee, Marianna Sabatino, Jiaqiang Ren, Steven Highfill, and Crystal Mackall (Abstract)

Production of anti-cd19 car t cells to support multicenter trials evaluating Kte- c19 in b cell malignancies, Marianna Sabatino (Abstract)

Evaluating The Quality Of Cell Counting Measurements Using Experimental Design And Statistical Analysis, Sumona Sarkar, Steven Lund, Anne Plant, and Sheng Lin-Gibson (Abstract)

Metabolism Regulation Of Phenotypic And Therapeutic Properties Of Human Mesenchymal Stem Cells, Teng Ma, Yijun Liu, Ang-Chen Tsai, and Xuegang Yuan (Abstract)

Novel Assays For Immunotherapy Product Characterisation And Potency Measurement, Damian Marshall, Moira Francois, Beata Surmacz-Cordle, Alex Chan, Assa Oumie, and Marc-Olivier Baradez (Abstract)

Implications Of The Caacb Virus Contamination In Biomanufacturing Project For Cell Therapy Manufacturers, Paul W. Barone, Michael E. Wiebe, James C. Leung, and Stacy L. Springs (Abstract)