Advancing Manufacture of Cell and Gene Therapies VIII

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24 conference program - Advancing Manufacture of Cell and Gene Therapies VIII, Fernanda Masri, Carolyn Yeago, Gargi Maheshwari, John Moscariello, and Bryan Wang (Article)

 

Time is muscle: Platform advancement for swift time-to-market in AAV manufacturing, Jiuyi Lu (Abstract)

 

Continuous processing of viral gene therapy vectors, Caryn Heldt, Natalie Nold, Taravat Sarvari, and Michael Betenbaugh (Abstract)

 

Leveraging a RNA-based lipid nanoparticle (LNP) gene writer system to generate Chimeric Antigen Receptor T cells (CAR-T) for in vitro and in vivo tumor activity, Jason Rodriguez; Pooja Sabhachandani; Kevin Johnson; Oscar Cabrera; Chris J. Caleca; Michael S. Magee; Alberto De Iaco; Kassi T. Stein; James B. Rottman, PhD; Donghui Li, PhD; Mohit Gupta; Michael T. Monte; Jane Wang; Bill Querbes; Michael C . Holmes; Cecilia Cotta-Ramusino; Madhusudan V. Peshwa; Yu Cao; Rebecca Levy; and Giulia Schiroli (Abstract)

 

Enhancing rAAV biomanufacturing: Process intensification strategies for streamlined upstream and downstream processing, António Roldão, João P. Mendes, Cristina Peixoto, and Ricardo J.S . Silva (Abstract)

 

Novel single plasmid technology for AAV production in HEK-293 suspension cells, Alina Venereo Sanchez (Abstract)

 

Towards a scalable AAV vector production at high volumetric efficiency, Prasanna Srinivasan, Christopher Canova, José Sangerman, Paul W. Barone, Jacqueline Wolfrum, Milla Neffling, Ji Young Anderson, Scott Miller, Graziella Piras, Anthony J. Sinskey, Richard D. Braatz, and Stacy L. Springs (Abstract)

 

Fit for purpose, DMSO-free preservation of cellular therapies, Alison Hubel and Adam Joules (Abstract)

 

High-density microbioreactor process designed for automated point-of- care manufacturing of CAR T cells, Wei-Xiang Sin, Narendra Suhas Jagannathan, Faris Kairi, Dedy Sandikin, Ka-Wai Cheung, Yie Hou Lee, Rajeev J. Ram, Lisa Tucker-Kellogg, and Michael E. Birnbaum (Abstract)

 

Scalable allogeneic CAR-T manufacturing: Perfusion optimization, multi- liter scale-up and automated harvesting in single-use stirred-tank bioreactors, Pierre Springuel, Tiffany Hood, Fern Slingsby, Nicola Bevan, Amanda Frangleton, Timo Schmidberger, Winfried Geis, Julia Hengst, Noushin . Dianat, and Qasim Rafiq (Abstract)

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Producing Ipsc derived functional Cd8+ T-cells in scalable stirred tank bioreactors, Liz Csaszar, Shri Joshi, Steve Woodside, Taylor Perkins, Chloe Hurling, Laxsha Thaya, Charlie Liu, Emily Titus, and Vaisakh Rajan (Abstract and Presentation)

 

Assessing robust bioprocess design through modulation of process input variables in the expansion of human induced pluripotent stem cell aggregates in Vertical-Wheel(R) bioreactors, Tiffany Dang; Breanna S. Borys; Hannah Worden; Brett D. Abraham; Julia Malinovska; Leila Larijani; Roman Krawetz; Emilie J. Gysel; Tamas Revay,; Bob Argiropoulos; Derrick E. Rancourt; Sunghoon Jung; and Michael Sa . Kallos (Abstract)

 

Powerful characterization of cell therapies via whole and single-cell next- generation sequencing, Tom Brieva, Saege Hancock, Neeraj Salathia, David Conant, and Dwight Baker (Abstract)

 

Optimizing the generation of hematopoietic progenitor cells from pluripotent stem cells in dynamic suspension culture, Thristan Paulo Taberna, Charles Lau, Peter W. Zandstra, Mona Siu, Elizabeth L. Castle, Han Hsuan Hsu, and Ali Murtaza (Abstract)

 

Combined Wnt activation and oxygen modulation enhance the manufacture and scale-up of pluripotent stem cell-derived cardiomyocytes in bioreactors, Pedro Vicente, Lara Inocêncio, Ana Louro, Beatriz Gamelas, Asier Ullate-Agote, Patxi Martin-Uriz, Olalla Iglesias García, Gonzalo Ríos-Muñoz, María Eugenia Fernádez-Santos, Alain van Mil, Joost Sluijter, Paula Aguirre, Felipe Prósper, Manuel M Mazo Vega, Martina Micheletti, Andrea Ducci, Paula Alves, and Margarida Serra (Abstract)

 

Towards a scalable, closed and automated platform for the production of cost-efficient allogeneic cell therapies: showcase of an exemplar iNK process, Márcia F. Mata, Juline Guenat, Jahid Hasan, Virginia Del Solar Fernandez, Marianne Henry, Aishwarya Nair, Vera Karels, Limor Zwi-Dantsis, Simona Zingaro, Charlotte Lee-Reeves, Mudith Jayawardena, Alexandru Robert Podovei, Antonia Karachaliou, Patrick Statham, Molly Tregidgo, Marina Tarunina, Yen Choo, Lam Lam, Sachin Luharia, Mathew Houppermans, and Tanya Ponomaryov (Abstract)

 

Bioprocessing of stem-cell derived allogeneic cell therapy products: enabling large-scale manufacturing, Mats Åkesson (Abstract)

 

Stem cell-derived pancreatic Islet encapsulation technologies for immobilized culture and transplantation, Corinne A. Hoesli, Jonathan A Brassard, Hamid Ebrahimi Orimi, Saleth Sidharthan, Arianna Castro Rojas, Brenden N Moeun, Marco Gasparrini, André Bégin-Drolet, Jean Ruel, Steven Paraskevas, and Richard Leask (Abstract)

 

Cell culture media-based cryo-formulations containg dimethyl sulfoxide minimize cryopreservation-induced cell damage in iPSC-derived effector cells, Victoria Karakis, Sandra Tamarin, Lavanya Peddada, Shiv Mistry, Bruno Marques, and Alyssa Suarez (Abstract)

 

Effects of temperature fluctuations on cryopreserved human induced pluripotent stem cells Post-thaw viability and cryo-Raman observation, Jun Okuda, Namiko Watanabe, Tetsuji Nakamura, Kenta Mizushima, Katsumasa Fujita, Masahiro Kino-oka, and Yasuaki Kumamoto (Abstract)

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Modular sensing, automation, and control for the production of cellular therapies, Stephen Balakirsky (Abstract and Presentation)

 

Digital twin-enabled feedback-controlled bioreactors with integrated process analytics for biomanufacturing of cell therapies, Bryan Wang, Bharat Kanwar, Walker Byrnes, Paloma Casteleiro Costa, Caroline Filan, Annie C. Bowles-Welch, Stephen Balakirsky, Francisco Robles, and Krishnendu Roy (Abstract)

 

Scaling AAV viral vector production processes up to manufacturing scale utilizing dynadrive single-use bioreactors, Paula Decaria (Abstract)

 

Cell placement in culture vessel after seeding is CPP in induction culture of retina pigment epithelial cells derived from Ipsc, Masahiro Kino-oka (Abstract)

 

Metabolic control, adaptive culturing, and AI predictions, a new generation of cell culturing devices, ADVA X3 case study, Ohad Karnieli (Abstract)

 

Towards in-silico scale-up of cell and gene therapy manufacturing, Christian Witz, Philipp Eibl, Alois Jungbauer, and Johannes Khinast (Abstract)

 

Evolving CAR cell therapy engineering: Challenges & opportunities, Isabelle Riviere (Abstract)

 

Rapid noninvasive analytical tool for cell and gene therapy products, Marc Taraban, William B. O’Dell, Katharine T. Briggs, Ioannis Karageorgos, Zvi Kelman, and Y. Bruce Yu (Abstract)

 

Predicting and enhancing cardiac potential of iPSC-derived cardiac progenitor cells through integrated multi-omic analysis, Aaron Simmons, Claudia Baumann, Xiangyu Zhang, Timothy J. Kamp, Rabindranath De La Fuente, and Sean P. Palecek (Abstract)

 

Release and characterization of VivoVec: Surface-engineered lentiviral vector for in vivo generation of CAR-T cells, Richard Rogers (Abstract)

 

Leveraging cell and gene therapy products' quality through a bioanalytics avenue, Patricia Gomes-Alves (Abstract)

 

Novel analytics for rapid adventitious agent detection in cell and gene therapy manufacturing, Stacy Springs, Emmanuel Kagning Tsinda, Charles A. Swofford, José Sangerman, Paul W. Barone, Jacqueline M. Wolfrum, Rajeev J. Ram, Jongyoon Han, Cheryl Siew Choo Chan, Shruthi Pandi Chelvam, Jiayi Huang, Yaoping Liu, Meenubharathi Natarajan, James Strutt, Alice Ng, Xiaolin Wu, Derrick Yong, Rohan Williams, Yie Hou Lee, and Ji Young L. Anderson (Abstract)

 

New methods and approaches for the analysis of new therapeutic modalities, Sunny Zhou (Abstract)

 

Process analytical utility of Raman microscopy for cell therapy manufacturing, James M. Piret, H. Georg Schulze, Shreyas Rangan, Martha Z. Vardaki, Katherine MacDonald, Diepiriye G. Iworima, Megan K. Levings, Timothy J. Kieffer, Michael W. Blades, and Robin F. B. Turner (Abstract)

 

Advancing Manufacture of Cell and Gene Therapies Award Lecture R&D supporting translation of cell based biotherapeutics, Paula Alves (Abstract)

 

NIST flow cytometry standards consortium enables quantitative and comparable characterization of cell and gene therapies, Lili Wang (Abstract)

 

Reducing regulatory risk with CMC strategy using gene therapy platforms, Doris Snow (Abstract)

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Regulatory updates and trends in cell and gene therapy, Kimberly Benton (Abstract and Presentation)

 

Scalable manufacturing of extracellular vesicles from human-induced pluripotent stem cells in stirred-tank bioreactors, Margarida Serra, Ana Filipa Louro, Cláudia Diniz, Paula Marques Alves, Margarida Serra, and Pedro Vicente (Abstract)

 

T cell expansion and phenotype can be tuned in stirred-tank bioreactors through temporal control of T cell activation, Margarida Serra, Constança Costa, Nádia Duarte, Paula Alves, Marta Costa, and Margarida Serra (Abstract)

 

Method development for the production of clinically relevant doses of human pluripotent stem cell derived cardiomyocytes, Andrew Prowse, Steve Dingwall, Zoe Clayton, Dinesh Selvakumar, James Chong, and Peter Gray (Abstract)

 

Flow-based membrane technology to engineer T-cells, Aida López Ruiz, Eric Slaughter, Zaining Yun, Kartik Bomb, Paige LeValley, Jacob McCoskey, Kara Levine, Aparajita Chatterjee, Dustin Chang, Christina Carbrello, Yama Abassi, Abraham Lenhoff, Catherine Fromen, and April Kloxin (Abstract)

 

Development of a xeno free system for scale-up of human bone marrow derived mesenchymal stromal cells using dissolvable microcarriers in a single-use vertical wheel bioreactor, Antonio Fernandez-Perez, Hilary Sherman, Sunghoon Jung, and Austin Mogen (Abstract)

 

Gradient plasma polymer coatings as closed culture vessel surface for manufacturing cell-based immunotherapy products, Balaji Ramachandran, Jessica Tian, Katie Campbell, Michel L. Tremblay, Pierre-Luc Girard-Lauriault, and Corinne Hoesli (Abstract)

 

Systematic bioprocess engineering used to optimize linear scale-up of size controlled PSC aggregates in vertical-wheel bioreactors, Breanna Borys, Govanni Estrada, and Sunghoon Jung (Abstract)

 

Recombinant carbohydrate binding module fusion proteins for the animal-component- free bioprocessing of stem cells, Brett Abraham, Poulomi Mondal, Peng Teng, Jinguang Hu, and Michael S. Kallos (Abstract)

 

Ambr250 system for optimization of stem cell aggregate expansion conditions, Brian Russell, Jerry Eriksson, Michael Delahaye, Rakesh Koppram, Mark Berge, and Nikita Balani (Abstract)

 

Process optimization in enhancing end-stage iPSC-derived immune-effector cell expansion, Chen-Yuan Kao, Kyle Smith, Jason A. Mills, and Bruno Marques (Abstract)

 

Process parameter development for the scaled generation of stem cell-derived pancreatic endocrine cells, Diepiriye Iworima, Robert Baker, Cara Ellis, Christopher Sherwood, Lisa Zhan, James Piret, and Timothy Kieffer (Abstract)

 

An optimized bioprocess for the transplantation of autologous bone-marrow derived mesenchymal stromal cells to treat equine joint injury, Emilie Gysel, Erin L. Roberts, Kasara Toth, Olivia Kenny, Brendan Nolan-Fisher, Thilo Pfau, W. Brent Edwards, W. Michael Scott, Roman J. Krawetz, Michael S. Kallos, and Holly D. Sparks (Abstract)

 

Enabling allogeneic T cell-based therapies: Scalable stirred-tank bioreactor mediated manufacturing, Lisa Prendergast and Inbar Friedrich Ben-Nun (Abstract)

 

A platform approach for producing engineered extracellular vesicles, Lisa Prendergast, Ali Navaei, and Davide Zocco (Abstract)

 

Designing a feeder-free expansion system for peripheral blood-derived NK cells, Janani Narayan, Pedram Motallebnejad, Jennifer One, Frank Cichocki, Wei-Shou Hu, and Samira M. Azarin (Abstract)

 

Designing a soluble factor-based expansion system through mechanistic understanding of feeder cell-mediated NK cell activation, Pedram Motallebnejad, Janani Narayan, Wei-Shou Hu, and Samira Azarin (Abstract)

 

Amino acid analysis indicates metabolic differences in multi-cytokine backpack- manufactured CAR T-cells, Milla Neffling, Heather Lin, Milla Neffling, K M Nawshad Hossian, Ji Young Anderson- Czajkowski, Graziella Piras, Sarwish Rafiq, and Erik Dreaden (Abstract)

 

Optimization of cell culture conditions for high transfection efficiency of HEK293 cells and production of viral vectors, Milla Neffling, Jaeweon Lee, Maurizio Cattaneo, Seongkyu Yoon, Milla Neffling, and Graziella Piras (Abstract)

 

Addressing scale-up challenges for the production of allogeneic, shear sensitive cell therapy products within the Vertical-Wheel bioreactor family, Omokhowa Agbojo and Sunghoon Jung (Abstract)

 

Understanding oxygen tension impact for enhanced clinical scale hematopoietic progenitor cell differentiation, Orchid Poponne, Nicole Santimauro, Bruno Marques, Keith Wilson, Jay Mills, Tom Donnelly, Margaret Brennan, Chris deBorde, and Bridget Adkins (Abstract)

 

Comparison of growth activity of bone marrow-derived mesenchymal stem cells in normoxic and hypoxic culture conditions through continuous passage, Rafianto Dwi Cahyo, Yuuki Ogawa, and Masahiro Kino-oka (Abstract)

 

Development of mass culture process for human induced pluripotent stem cells in suspension, Riku Yamamoto, Tomohiro Tokura, and Masahiro Kino-oka (Abstract)

 

Investigate the stability of seeding process of mesenchymal stem cell on microcarriers by considering heterogeneity, Riku Yamamoto, LIAO YUNHAO, and Masahiro Kino-oka (Abstract)

 

Verification of built-in calibration function of a pH sensor for sample-free bioprocess operations, CD Feng (Abstract)

 

Building global opportunities between development and quality (Qualified Persons, QPs) for ATMPs, Tiffany Rau and Nollaig Buckley QP (Abstract)

 

Automated TruStableTM rAAV production, Christopher Abeles, Sandhya Pande, and Ken Prentice (Abstract)

 

Use of conventional flow cytometry to study extracellular vesicles, Gregg Nyberg, Eli Kraus, Yun Chen, and Manish Tandon (Abstract)

 

At-line quantitation for the nicontinic acid to nicotinamide ratio as a biomarker for microbial combination of cell cultures, Kenion Blakeman, Ji Young L. Anderson, Scott E. Miller, Alice Ng, Jiayi Huang, Meenubharathi Natarajan, Yie Hou Lee, Rohan Williams, Paul W. Barone, Stacy L. Springs, and Jacqueline M. Wolfrum (Abstract)

 

Improving cell and gene therapy manufacturing processes by automated on-line and in- line bioprocess analytical technologies, Nick Randall, Colin Gavin, Stephen Driscoll, Wolfgang Kuennecke, Michael Hartlep, Milla Neffling, and Graziella Piras (Abstract)

 

Adsorptive separation of viral gene therapy vectors, Alois Jungbauer, Nico Lingg, Patricia Aguilar, and Dietmar Palmberger (Abstract)

 

Screen your AAV production process – From high throughput to scalabilit, Kathrin Teschner, Stefano Boi, Yi-hsuan Huang, Vera Ortseifen, Pia Brinkert, Alyssa Buve, Kristin Thiele, and Sandra Klausing (Abstract)

 

Development of a scale down bioreactor model for AAV gene therapy, Arun Bagale, Brandi Arterberry, Bharat Patel, Ryan Burger, Kory Blocker, Dax Lamar, and Elizabeth Benoy (Abstract)

 

Utilizing enhancers to elevate AAV productivity, Brandi Arterberry, Arun Bagale, Elizabeth Benoy, Ryan Burger, Kory Blocker, Bharat Patel, and Dax Lamar (Abstract)

 

Strategies for enhanced Adeno-Associated Virus (AAV) vector formulations, Braulio Carrillo Sanchez, Raquel Fernández García, Spyridon . Gerontas, John Hales, Prof. Jonathan Aylott, and Paul Dalby (Abstract)

 

A scalable 3-D printed bioreactor for adherent cell based production of viral vector, Carlos Cantú, Nicholas P. McMahon, Angelica Fernandez, Madison Morales, Kreg A. Zimmern, and Jian Ling (Abstract)

 

Optimizing triple transfection for enhanced rAAV production: A Response Surface Methodology approach, Jesús Lavado García, David Catalán-Tatjer, Konstantina Tzimou, and Lars Keld Nielsen (Abstract)

 

A recombinase-mediated cassette exchange capable stable cell line for configuring inducible AAV production cassettes, Erica Green and Kelvin H. Lee (Abstract)

 

Mechanistic modeling for efficient manufacturing of rAAV with the Sf9/BEVS platform, Francesco Destro, John Joseph, Prasanna Srinivasan, Joshua M. Kanter, Caleb Neufeld, Jacqueline M. Wolfrum, Paul W. Barone, Anthony J. Sinskey, Stacy L. Springs, Sylvain Cecchini, Robert M. Kotin, and Richard D. Braatz (Abstract)

 

DNA impurity reduction by a stably integrated staphylococcal nuclease is compatible with high-titer suspension serum-free rAAV manufacturing, Geoffrey Howe, Mehtap Bal, Matt Wasmuth, Giulia Massaro, Ahad A. Rahim, Sadfer Ali, Milena Rivera, Desmond M. Schofield, Aminat Omotosho, John Ward, Eli Keshavarz-Moore, and Darren N. Nesbeth (Abstract)

 

Optimization of scalable rAAV production for gene therapy – Leveraging at-line amino acid measurements for bioprocess modeling-driven approaches, Graziella Piras, Milla Neffling, John Joseph, Tam N T Nguyen, Ji Young Anderson-Czajkowski, Scott Miller, Graziella Piras, Anthony J. Sinskey, Richard D. Braatz, Jacqueline Wolfrum, Paul W. Barone, and Stacy L. Springs (Abstract)

 

Evaluation of small molecule antagonists of cellular innate immunity for efficient manufacturing of T-cell therapeutics, Andrea Vervoort, Jondavid de Jong, Keara Sutherland, and Andrea Vervoort (Abstract)

 

Introducing a high-performance T-cell culture medium that is free of animal derived components, Joanna Kern, Lauren Kapus, Evan Zynda, and Kyle Zastrow (Abstract)

 

Establishing modularity in AAV manufacturing – Deployment of engineered cell lines and advanced analytics in traditional manufacturing platforms, Brandon Razooky (Abstract)

 

High-yield AAV production and improved manufacturability across multiple serotypes via a novel cell engineering platform, Kathy Ngo, Lawrence Chasin, and Larry Forman (Abstract)

 

An efficient plasmid ratio optimization for rAAV production can be achieved using a mixture design, Konstantina Tzimou, David Catalán-Tatjer, Jesús Lavado-García, and Lars Keld Nielsen (Abstract)

 

GlutaMAX decay offers a more sensitive indication of cell health than LDH enzymatic activity or Trypan blue exclusion, Lauren Peters, Margaret Moran, and Neil Templeton (Abstract)

 

Metabolic phenotype of high productivity within transient transfection AAV production, Margaret Moran, Neil Templeton, and Lauren Peters (Abstract)

 

A process development approach to a platformable and robust scale up for enrichment of full AAV capsids using membrane chromatography, Mark Schofield, Isabella Depina, Mark Schofield, and Aydin Kavara (Abstract)

 

Process optimization and intensification of AAV2 vector production: Scale down and rapid scale up upstream processes, Nazgul Wagner, Dennis Carpentier, Moritz Speckenbach, and Julia Niemann (Abstract)

 

Informing next-generation cell and gene therapy technologies through an evaluation of currently approved and late clinical stage medicines, Niah Goudar (Abstract)

 

Adventitious agent control in gene therapy processing, Nicholas Marchand, Luke McCarney, Michelle Olson Peabody, and Mike Collins (Abstract)

 

Assessing the impact of evolutionary pressures on the performance of AAV vector production in HEK293 cells, Nikolaus Virgolini, Georg Smesnik, Nicole Borth, Astrid Dürauer, and Maral Rahimzadeh (Abstract)

 

Asymmetrical-flow field-flow fractionation and Taylor dispersion analysis for characterization of Adeno-Associated Viruses for gene therapy, Nikolaus Virgolini, Maral Rahimzadeh, Catarina Maia, Verena Buchacher, Astrid Dürauer, Sabrina Leigheb, and Patricia Pereia Aguilar (Abstract)

 

Assisting quality by design through design of experiments to overcome industry bottlenecks for Adeno-Associated Virus (AAV) downstream processing, Paul Cashen, Franziska Bollmann, Marc Noverraz, and Azbe Znidarsic (Abstract)

 

Continuous rAAV vector production using the baculovirus expression vector system, John Joseph, Francesco Destro, Prasanna Srinivasan, Joshua M. Kanter, Caleb Neufeld, Jacqueline M. Wolfrum, Sylvain Cecchini, Robert M. Kotin, Anthony J. Sinskey, Paul W. Barone, Richard D. Braatz, and Stacy L. Springs (Abstract)

 

Therapeutic viral vectors: Manufacturing, challenges, and platform-based innovation, Rachel Legmann, Keen Chung, Rene Gantier, Frank Agbogbo, Ganesh Krishnamoorthy, and Kathleen Mihlbachler (Abstract)

 

Plasmid engineering to improve AAV productivity and packaging efficiency, Ruth McDermott, Chien-Ting Li, Bingnan Gu, and Peng Wang (Abstract)

 

TruStableTM: A fully integrated inducible stable producer cell line for AAV manufacturing, Sandhya Pande, Corey Johnson, Ken Prentice, Ramsey Saleem, Blake Engelbert, Tina Bi, and Chris Abeles (Abstract)

 

Designing performance membranes for challenging & demanding separation applications through advanced characterization techniques, Adolfo Nicoloso, Kiersten Fraser, Christian Julien, Thomas Vandromme, and Jessica McRoskey (Abstract)

 

Animal-origin free peptones enhance adenovirus production, Wen-Yang Tsai, Syed Muaz Khalil, James W. Brooks, Stacy Holdread, Aaron Robinson, Anna-Barbara Hachmann, Matt Rosecrans, and Ashwin Gurunathan (Abstract)

 

Towards a fully defined viral vector production process, Nelson Ndahiro (Abstract)