January 27-31, 2019
Loews Coronado Bay Hotel Coronado, California, USA

Editors:   Dolores Baksh, GE Healthcare, USA
  Rod Rietze, Novartis, USA
  Ivan Wall, Aston University, United Kingdom

The articles for these proceedings are not peer-reviewed.



Conference Program, Dolores Baksh, Rod Rietze, and Ivan Wall (Article)

Biomanufacturing cardiac cells from human pluripotent stem cells, Sean Palecek (Abstract)

Acoustic cell processing - An innovation in cell therapy manufacturing, Nina Bauer (Abstract)

Process development and manufacture of primary human T-cells in scalable, automated stirred-tank bioreactors, Elena Costariol, Marco Rotondi, Martina Micheletti, and Qasim Rafiq (Abstract)

Animal component free cell culture media development: The approach from the North, Panos Chrysanthopoulos, Anthony Eiliazadeh, and Sagar Kokal (Abstract)

Transitioning from manual to stirred-tank bioreactor manufacturing of IDCT, An allogeneiccell therapy to treat lumbar degenerative disc disease, Lara Silverman, Gary Pigeau, Terry Tandeski, Gala Dulatova, Will Heaton, Isaac Erickson, Daniel Rodriquez-Granrose, Azher Razvi, Zoe Anderson-Jenkins, and Meghan Rooney (Abstract)

Scale up of iPSC-derived product manufacturing, Peter Fuhrken (Abstract)

Enabling large-scale ex vivo production of megakaryocytes and platelets from CD34+ cells using gas-permeable surfaces and microfluidic bioreactors, Andres F. Martinez and William M. Miller (Abstract)

Functionalized microcarriers for Enhanced CAR T cell manufacturing, Nate Dwarshuis, Hannah Wilson Song, Krishnendu Roy, and Anokhi Patel (Abstract)

Scale up of allogeneic cell therapy manufacturing in single-use bioreactors: Challenges, insights and solutions, Brian Lee, Yas Hashimura, Sunghoon Jung, and Maximilian Lee (Abstract)

Comparative analysis of FBS containing media and serum free chemically defined media, CellCor for adipose derived stem cells production, Jooyoun Lee, Min Hee Kang, Yuri Chun, Hong-Seok Kang, YoungJung Kim, So Min Lee, Ji Young Choi, and Sang Gyu Park (Abstract)

Developing a toolkit to engineer viral vector manufacturing and next generation gene therapies, Fernanda Masri and Michael Greene (Abstract)

Taking an engineering approach to empower breakthrough therapies, Anil Narasimha (Abstract)

A single-use chromatographic purification platform for viral gene transfer vectors & viral vaccines, Pavel Marichal-Gallardo, Yvonne Genzel, Kathleen Börner, Dirk Grimm, Michael Wolff, and Udo Reichl (Abstract)


Tangential flow filtration and scalability in viral vector purification, Eni Sterjanaj, Heather Mall, Rachel Legmann, and Jacky Dang (Abstract and Presentation)

Scaling up lentiviral vector production from stable producer cells, Vanja Misic, Howard Kim, Nadejda Andreev, and Aaron Dulgar-Tulloch (Abstract)


Key engineering challenges in the biomanufacturing of lentiviral viral vectors, Peter Jones (Abstract and Presentation)

Technology transfer of cell and gene therapy products into a new GMP facility: Success factors and key challenges, LiYing Yang (Abstract and Presentation)

Identification of CAR T Cell Critical Quality Attributes and Critical Process Parameters, Ryan Larson (Abstract)

The development of a 14-day non-viral engineered CAR T-cell process, Emi Y. Tokuda, Michael Jensen, and Joshua Gustafson (Abstract)

Effecting clinical starting material quality and the impact to downstream processing, Dominic Clark (Abstract)

Raman spectroscopy of cells as a process analytical technology, Jamie Piret (Abstract)

The dynamic mass spectrometry probe (DMSP) - Advanced process analytics for therapeutic cell manufacturing, health monitoring and biomarker discovery, Andrei G. Fedorov, Mason A. Chilmonczyk, Austin L. Culberson, Peter A. Kottke, Gian C. Rivera Crespo, and Robert E. Guldberg (Abstract)

Improving functional maturation of human pluripotent stem cells derived cardiomyocytes through metabolic understanding, Margarida Serra, Cláudia Correia, Alexey Koshkin, Patricia Duarte, Maria João Sebastião, Patrícia Gomes-Alves, Ana Teixeira, Paula M. Alves, David Elliott, Dongjian Hu, and Ibrahim Domian (Abstract)

Single cell analysis of viral transduction as a novel toolbox for an improved characterization of cell therapy products, Nicole Nicholas, Vincenzo Di Cerbo, Ilaria Santeramo, Enas Hassan, Beata Surmacz-Cordle, and Damian Marshall (Abstract)

Evaluating the impact of culture conditions on human mesenchymal stem/stromal cell-derived exosomes through FTIR spectroscopy, Ana Fernandez, Maria João Canha Pereira, Luís Ramalhete, Sandra Aleixo, Cláudia Lobato da Silva, Joaquim M. S. Cabral, and Cecília R.C. Calado (Abstract)

The emerging role for AI in cell and gene therapy manufacture, Damian Marshall (Abstract)

Efficient model driven design of cell-based product manufacturing, Robert Thomas, Katie Glen, Elizabeth Cheeseman, Maryam Shariatzadeh, Ben Diffey, and Adrian Stacey (Abstract)

Automated data capture and monitoring – An analytics toolbox, Dina Ibrahim and Kevin Boomhouwer (Abstract)

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

Establishing successful commercial CAR T manufacturing on a short timeline: A process development and planning perspective, Tom Brieva (Abstract)


Novel supply chain and process modeling for cell therapy manufacturing and distribution, Chip White, Ben Wang, Kan Wang, Reid Bishop, Aaron Levine, Brian Liu, Bhavya Divvela, Aubrey Incorvaia, Kris Saha, and Tava Das (Abstract and Presentation)

A roadmap to successful commercialization of autologous CAR T-cell products with centralized and bedside manufacture, Tania Pereira Chilima and Suzanne S. Farid (Abstract)

Modeling of commercial autologous cell therapy manufacturing using simulation and optimization, David Zhang (Abstract)

Automated data management strategies drive cell therapy success, Christophe Suchet (Abstract)

The tech enabled pharma company, Neil Tiwari (Abstract)

Leveraging digital solutions to predict disease and patient access to transformative therapies, Ben Newton (Abstract)

Advancing manufacture of cell and gene therapies award lecture, Greg Russotti (Abstract)

Thalassaemia and gene therapy from a patient’s perspective – Why your work is so important, Laurice Levine (Abstract)

BIO regulates the ex vivo expansion and function of hematopoietic stem cells by inhibiting GSK-3β, Qihao Sun, Haibo Cai, and Wen-Song Tan (Abstract)


Single use disposable BioSettler removes the dead cells and cell debris selectively to increase the viability percentage of mammalian cells (e.g., CAR-T) during expansion, Dhinakar Kompala (Abstract and Presentation)

Use of the Nanobridge system for the Rapid Production of Pluipotent Stem Cells and Neural Progenitor Cells, Peter P. Gray, Xiaoli Chen, Linda Harkness, Zhongfan Jia, Michael Monteiro, and Martin Pera (Abstract)

Challenges and opportunities for closed processing in autologous CAR-T manufacturing, John Wesner, Catherine Colandro, Eliza Dornbush, and Christopher Abeles (Abstract)

Scalable generation of cerebellar neurons from pluripotent stem cells, Carlos Rodrigues, Evguenia Bekman, Sandra H. Vaz, Carlos A.V. Rodrigues, Maria Carmo-Fonseca, Joaquim M.S. Cabral, Tiago G. Fernandes, Yas Hashimura, Brian Lee, and Sunghoon Jung (Abstract)

Human pluripotent stem cell expansion in vertical-wheel bioreactors, Carlos Rodrigues, Joaquim M.S. Cabral, Cláudia C. Miranda, Diogo E.S. Nogueira, Yas Hashimura, Sunghoon Jung, and Brian Lee (Abstract)

Pancreas organoids for type I diabetes mellitus - Is it feasible as a cell therapy?, Bart van Dijk and Nasser Sadr (Abstract)

Establishment and evaluation of the suspension culture system for umbilical cord- derived mesenchymal stromal cells, Hikari Hasegawa, Takashi Takijiri, Tetsuo Koike, Masayo Yumoto, Tetsuo Furuno, Atsuko Takahashi, Akiko Hori, Tokiko Nagamura-Inoue, and Eiichi Koga (Abstract)

Scalable manufacturing of human mesenchymal stem/stromal cells and derived exosomes in the single-use, vertical-wheel bioreactor system using a human platelet lysate culture supplement, Ana M. Fernandes-Platzgummer, Diogo de Sousa Pinto, Miguel de Almeida Fuzeta, Carlos A.V. RodrigueS, Nuno Bernardes, Sung-Hoon Jung, Rong-Jeng Tseng, William Milligan, Brian Lee, Cláudia Lobato da Silva, and Joaquim M. S. Cabral (Abstract)

Viable manufacture of cell therapies through the integration of multiple unit processes onto a counter-flow centrifugation device, Alexander S. Klarer and David Smith (Abstract)

Developing a novel microchannel emulsification device for diabetes cell therapy, Christina Bitar, Tong In Oh, Wook Park, and Seoyoung Jang (Abstract)

A scalable xeno-free microcarrier suspension bioreactor system for regenerative medicine biomanufacturing of hMSCs, Josephine Lembong, David Wang, Robert Kirian, Ang-Chen Tsai, Kenny Cruz, Francisco Rosello, Kayley Cox, Yas Hashimura, Sunghoon Jung, Taby Ahsan, Jon Rowley, and Timothy Olsen (Abstract)

Further evaluation of a novel COP container system for the cryopreservation of adherent and suspension human cell types, Alexander Lyness, Matthew Gehrmann, Andrew Picken, and Robert J. Thomas (Abstract)

Enabling stem cell based therapies: Adaptable and scalable manufacturing of human pluripotent stem cells, Haritha Vallabhaneni, Inbar Friedrich Ben-Nun, Puspa Pandey, Farjad Shafighi, and Eytan Abraham (Abstract)

Maintaining CD4/CD8 ratio and Th1-CTL subsets of chimeric antigen receptor (CAR)-T cells in serum-free culture conditions, Hsin-Lin Lu, Pei-Ju Leng, Wei-Kuang Chi, and Yu-Hua Su (Abstract)


Scale-up study for ex-vivo expansion of allogeneic natural killer cells in stirred-tank bioreactor, Juyoung Kim, Hyung Jin Nam, Sang Hyun Lee, Jong Beom Ku, Seung Ryel Han, Hye Jin Shin, Yu Kyeong Hwang, and Sang Hoon Paik (Abstract and Presentation)

A step closer to industrial scale manufacture of exosomes - Adaptation of clinical grade neural stem cells from 2D to 3D culture, Nicola Goddard, Dale Moulding, Daniel G. Bracewell, Randolph Corteling, and Ivan Wall (Abstract)

In vitro high expansion of chimeric antigen receptor (CAR)-T cells in serum-free process conditions, Wei-Kuang Chi, Pei-Ju Leng, Hsin-Lin Lu, and Yu-Hua Su (Abstract)

Reducing variability in conditions for cell handling improves MSC yields, Ken Rando, Alicia D. Henn, Shannon Darou, and Randy Yerden (Abstract)

Impact of the dynamic culture system for 3D high cell density neural differentiation of hESC in electrospun PCL scaffolds, Veronique Chotteau, Mattias Leino, Carolina Åstrand, Brendan Robb, and Robert McKean (Abstract)

Superior expansion of long-term hematopoietic stem cells using StemPro™ HSC medium kit, Chad MacArthur, Navjot Kaur, Janet J. Sei, Abigail H. Becker, David Kuninger, and Mohan Vemuri (Abstract)

An automated and closed system for patient specific CAR-T cell therapies, Joseph W. O'Connor, Kalyani Daita, Eytan Abraham, Debargh Dutta, Yaling Shi, and Nuala Trainor (Abstract)

Automated manufacturing for iPSC-derived retinal pigment epithelial cells, Masahiro Kino-oka (Abstract)

Isolation and expansion of human bone marrow-derived mesenchymal stem cells (hMSCs) directly on microcarriers in a stirred tank bioreactor, Christopher J. Hewitt, Mariana Petronela Hanga, Panagiota Moutsatsou, Shibani Ratnayake, Alvin W. Nienow, and Qasim A. Rafiq (Abstract)

Mitigating the risks of adventitious agents in serum: Elimination or viral inactivation, Kelly A. O'Neill (Abstract)

LentiPro stable producer cells: Delivering scalable and reliable lentiviral vector manufacturing, Manuel Carrondo, Ana S. Coroadinha, Ana Formas-Oliveira, Tiago Vaz, Ana F. Rodrigues, and Hélio A. Tomás (Abstract)

Therapeutic genome editing for Charcot-marie-tooth disease type 1a, Jae young Lee, Ji-su Lee, Hee Kyoung Kim, Hyun Hwang, Geon Kwak, Young Bin Hong, Byung-Ok Choi, Daesik Kim, Seokjoong Kim, Jung Min Lee, Dong Woo Song, Ho Sung Yu, Kyu Jun Lee, and Hee Sook Bae (Abstract)

Engineering characterization of a versatile vertical-wheel bioreactor for cell and gene therapy, Matthew Croughan, Nathan Starkweather, Brian Lee, Yas Hashimura, Samantha Guerra, and Daniel Giroux (Abstract)

A novel scalable manufacturing platform for T-cell activation and expansion in adoptive T-cell therapy, Jian Ling (Abstract)

Optimising HEK293T culture for the improved manufacture of gene therapies, Angharad Evans (Abstract)

A scalable and physiologically relevant system for human induced pluripotent stem cell expansion and differentiation, Yuguo Lei, Qiang Li, and Haishuang Lin (Abstract)

Towards an allogeneic therapy for neural regeneration, Rachael Wood and Ivan Wall (Abstract)

Engineering and manufacturing of probiotic E. Coli to treat metabolic disorder, Eugene Antipov, Vincent Isabella, Yves Millet, Binh Ha, Mary Castillo, Dean Falb, Sarah Rowe, David Lubkowicz, Adam Fisher, Cami Anderson, Ning Ling, Kip West, Pip Reeder, Munira Momin, Chris Bergeron, Caroline Kurtz, and Paul Miller (Abstract)


Development of a closed CAR-T manufacturing process, Loo-Yong Steven Kee, Calley Hirsch, Devina Ramsaroop, Elizabeth Csaszar, Danylo Sirskyj, and Aaron Dulgar-Tulloch (Abstract and Presentation)

Leveraging bioprocess platform technology for the development of a robust, scalable, and economic manufacturing process of allogeneic CAR-T cell therapy products, Bernadette Dahlin (Abstract)

Characterization of CAR-T transduction parameters using a lentiviral vector, Stefanie Shahan, Sherry Zhou, Ryan Shorr, and Thomas Brieva (Abstract)

Platelet lysate boosts transgene levels and maintains undifferentiated T cell subtypes following lentiviral delivery to human primary T cells, Christina Dann, Brianna McSwain, Steve Charlebois, and Emanuele Canestrari (Abstract)

New viral and non-viral platforms for T-cell engineering, Chad MacArthur (Abstract)

Development of feeder-free PSC culture system enabling translational & clinical research, Chad MacArthur (Abstract)

Xeno-free expansion of late-adherent human olfactory mucosa cells: Towards an allogeneic therapy for neural regeneration, Gerardo Santiago-Toledo, Ana Valinhas, Victoria Roberton, Parmjit Jat, and Ivan Wall (Abstract)

Decoding human cardiac stem cells regenerative potential in acute myocardial infarction, Maria Serra, Ivo Reis, Itziar Palacios, Margarida Serra, Patrícia Gomes-Alves, and Paula Marques Alves (Abstract)

Advancing the knowledge on immunomodulatory properties of human cardiac stem cells, Maria Serra, Rámon Menta, Maria João Sebastião, Itziar Palacios, Paula Marques Alves, Belén Sanchez, Olga DelaRosa, Wilfried Dalemans, Eleuterio Lombardo, and Patrícia Gomes-Alves (Abstract)

Cryopreservation critical process parameters: Impact on post-thaw recovery of cellular product, Alireza Abazari, Brian J. Hawkins, and Aby J Mathew (Abstract)

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

Refining iPSC-based 3D neural cell models and characterization tools to address brain microenvironment-related diseases, Margarida Serra, Ana Paula Terrasso, Daniel Simão, Francisca Arez, Marta M. Silva, Patrícia Gome-Alves, Paula M. Alves, Neus Bayó-Puxan, Nuno Raimundo, and Eric J. Kremer (Abstract)

Metabolite-based model predictive control of cell growth, Kathleen Van Beylen, Ali Youssef, Jean-Marie Aerts, Toon Lambrechts, and Ioannis Papantoniou (Abstract)

Streamlining cell therapy manufacturing: Automated production and integrated data management, Sébastien de Bournonville, Toon Lambrechts, Thomas Pinna, Ioannis Papantoniou, Liesbet Geris, and Jean-Marie Aerts (Abstract)

Application of quality by design tools to upstream processing of platelet precursor cells to enable in vitro manufacture of blood products, Elizabeth A. Cheeseman, Katie E. Glen, Adrian Stacey, J. Catherine Beltran-Rendon, Rebecca L. L. Moore, Mark J. S. McCall, Thomas Moreau, Cedric Ghevaert, and Robert J. Thomas (Abstract)

Dielectric spectroscopy monitoring of a bioreactor process for hiPSC expansion and differentiation, Pedro Vicente, Inês A. Isidro, Daniel AM Pais, Bernardo Abecassis, Mara Domingues, Margarida Serra, and Paula M. Alves (Abstract)

Scaling up and industrialization the production and purification of viral vectors for therapeutic use: Challenges and progress, Rachel Legmann, Brian Gardell, Deepika Vallabhaneni, Heather Mallory, Keen Chung, Irit Meivar-Levy, and Sarah Ferber (Abstract)

Optimization of HEK293T suspension cultivation with a DoE-approach in ambr®15 microbioreactor, Franziska Bollmann, Diana Riethmüller, Erik Johansson, and Alexander Tappe (Abstract)

Determining the role of lactate in induced pluripotent stem cell metabolism, Daniel Odenwelder and Sarah W. Harcum (Abstract)

Computational fluid dynamics (CFD) modeling of single-use, vertical-wheel bioreactors as a predictive scale-up tool for large scale stem cell culture, Breanna Borys, Tylor Walsh, Sunghoon Jung, Brian Lee, Yas Hashimura, and Michael Kallos (Abstract)

A cost/quality analysis of primary human T-Cells in different expansion systems, Marco C. Rotondi, Elena Costariol, and Qasim Rafiq (Abstract)

High shear stress from a resonance phenomenon in Wave bioreactor revealed by computational fluid dynamics simulation, Veronique Chotteau, Caijuan Zhan, Erika Hagrot, and Luca Brandt (Abstract)

Defining cell culture dynamics in response to growth factor provision for efficient optimization of cell based therapies, Katie E. Glen, Robert J. Thomas, Elizabeth A. Cheeseman, and Adrian J. Stacey (Abstract)

Development of media production processes for CAR-T therapies, Ryan C. Glussi, David Hsiung, and Thomas Brieva (Abstract)

Economics of lentiviral vector processes, Ruxandra-Maria Comisel, Bo Kara, and Bo Kara (Abstract)

CMC strategy for AAV gene therapies in the age of RMAT designation, Rajiv Gangurde and Luis Maranga (Abstract)

CAR T-cell therapies: The concept of a dynamic supply chain, Maria Papathanasiou and Nilay Shah (Abstract)

Advancing the robust manufacture of T-cell therapies through the application of stirred tank bioreactors, Alexander S. Klarer (Abstract)