ECI Digital Archives

Advancing Manufacture of Cell and Gene Therapies VII

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Conference Program, Sharon Brownlow, Sean Palecek, Damian Marshall, and Fernanda Masri (Article)

 

Directed evolution of novel AAV vectors for clinical gene therapy, David V. Schaffer (Abstract)

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Integrated end-to-end MVA viral vector production: Perfusion culture shows economical advantage over batch culture, Gwendal Gränicher, Pavel Marichal-Gallardo, Sven Göbel, Masoud Babakhani, Ingo Jordan, Volker Sandig, Yvonne Genzel, and Udo Reichl (Abstract and Presentation)

 

Process economics evaluation of Adeno-associated Viral Vector (AAV) manufacturing, Annabel Lyle, Christos Stamatis, Martyn Hulley, Thomas Lin, Albert Schmelzer, Richard Turner, and Suzanne Farid (Abstract)

 

Developing a suspension transfection platform to produce adeno- associated viruses, Kory Blocker, Jason Rush, Melynda Dalzon, William Roberts, Boris Petkov, Simin Zaidi, Julie Johnston, and James Wilson (Abstract)

 

Scalable downstream purification of recombinant adeno-associated viral vectors, Sarah Blackmore, Todd P. Sanderson, Mark Schofield, Nick Marchand, Aydin Kavara, Adam Hejmowski, Shawn Tansey, Rajeshwar Channawar, Michelle Olson, Anne MacIntyre, Amanda Rose, Kurt Boenning, Julio Huato, and Mike Collins (Abstract)

 

Industrialization of the GMP manufacture of exosome therapeutics and opportunities for further multifold process productivity increase, Konstantin Konstantinov (Abstract)

 

Considerations of manufacturability for AAV based gene therapy products for rare diseases, Nripen Singh (Abstract)

 

Process development of a serum-free and scalable lentiviral vector manufacturing platform for cellular immunotherapies, Carme Ripoll Fiol, Dale Stibbs, John Welsh, and Qasim Rafiq (Abstract)

 

A dual platform revolutionizing gene therapy manufacturing, Tania Pereira Chilima (Abstract)

 

Disruptive technologies for cell therapy manufacturing, Jen Moody (Abstract)

 

Scalable downstream process development and manufacturing in cGMP for human iPSC derived products, Sho Sato, Tomoaki Kurakazu, Hideaki Kagawa, Yina Santiago-Rodriguez, and Peter Fuhrken (Abstract)

 

Key drug product considerations for iPSC-derived NK cell therapies, Lavanya Peddada (Abstract)

 

Challenges and solutions for allogeneic cell therapy manufacturing, Brian Lee, Sunghoon Jung, Yas Hashimura, Hannah Worden, Kelly Gray, Kenny Cruz, and Breanna Borys (Abstract)

 

Advanced manufacturing process design for Mesenchymal Stromal Cell therapies, Bryan Wang, Annie Bowles-Welch, Bharat Kanwar, Walker Byrnes, Zhaonan Liu, Chuck Zhang, Stephen Balakirsky, Carolyn Yeago, and Krishnendu Roy (Abstract)

 

Overcoming cell therapy manufacturing barriers through innovation and partnership, Rupa Pike (Abstract)

 

Extra cellular vesicles separation and biophysical characterization, Alois Jungbauer, Patricia Aguilar, Viktoria Mayer, and Alexander Zollner (Abstract)

 

Process and analytical development challenges for the incorporation of gene edits into T cell therapies, Thomas Brieva (Abstract)

 

Development of autologous adipose derived mesenchymal stem cell therapy: Lessons learned from treating more than 250 patients, Allan Dietz (Abstract)

 

Journey to commercialization of a complex, biological ancillary material, Lili Belcastro, Norbert Hentschel, and Takeshi Nishiura (Abstract)

 

Virus-Free CRISPR CAR T cells induce solid tumor regression, Lauren Sarko, Katherine P. Mueller, Nicole J. Piscopo, Matthew H. Forsberg, Louise A. Saraspe, Amritava Das, Brittany Russell, Madeline Smerchansky, Lei Shi, Adeela Ali, Cicera R. Lazzarotto, Shengdar Q. Tsai, Christian M. Capitini, and Krishanu Saha (Abstract)

 

Cell Therapy Analytics: Challenges and Opportunities, Somayeh Tarighat (Abstract)

 

Integrated intracellular organization and reorganization of the human stem cell, Susanne Rafelski (Abstract)

 

Digital path to Industry 4.0: The role of data sciences in the cell & gene therapy space, Marc-Olivier Baradez (Abstract)

 

Assessing interaction networks within iPSC expansion bioprocessing to elucidate complexities of cellular phenotype and develop advanced process control strategies, James Colter, Breanna S. Borys, Tania So, Ian Lewis, Kartikeya Murari, and Michael Kallos (Abstract)

 

Hybrid modeling approaches for autologous cell therapy process characterization, Mridul Dalmia (Abstract)

 

Electroporative Nano-Structures for Centrifuge-free and Efficient Immune T-cell Transfection, Andy Kah Ping Tay (Abstract)

 

Single-cell Multi-omics for accelerated therapeutic characterization and release, Yan Zhang (Abstract)

 

High resolution single cell profiling of human hematopoietic stem cell drug products, Luca Biasco (Abstract)

 

Scientific solutions for regulatory guidelines: Unlocking AAV product testing, Stuart Wright (Abstract)

 

Platform approaches to mRNA analytical testing methods, Amy Glekas (Abstract)

 

Applying new technology and approaches to the analytical challenge of assessing the empty full ratio for adeno associated virus, Ian Anderson (Abstract)

 

Development of a disruptive mass photometry technology for AAV empty full quantification, Maria Barreira, Lily Li, Carolina Pinto Ricardo, and Tony Bou Kheir (Abstract)

 

Quality implications of cryopreservation: Building a small-scale model to determine the shelf-life of cryopreserved blood products for drug product manufacturing, Purna Venkataraman, Lusine Bozoyan, Craig Jones, Francis John Pierciey, and Lesley Chan (Abstract)

 

Manufacturing of gene-modified human mesenchymal stromal cells in microcarriers and agitated conditions, Pedro Silva Couto, Dale Stibbs, and Qasim Rafiq (Abstract)

 

Virus-Free CRISPR CAR T cells induce solid tumor regression, Lauren E. Sarko, Katherine P. Mueller, Nicole J. Piscopo, Matthew H. Forsberg, Louise A. Saraspe, Amritava Das, Brittany Russell, Madeline Smerchansky, Lei Shi, Adeela Ali, Cicera R. Lazzarotto, Shengdar Q. Tsai, Christian M. Capitini, and Krishanu Saha (Abstract)

 

Process optimization for adenovirus-based viral vector vaccines, Annabel Lyle, Christos Stamatis, Martyn Hulley, Thomas Linke, Albert Schmelzer, Richard Turner, and Suzanne Farid (Abstract)

 

The role of NIIMBL to advance manufacturing for Cell and Gene Therapy treatments, Barry Buckland (Abstract)

 

An efficient microcarrier based Adeno-associated virus production method, Brian Ladd, Veronique Chotteau, and Torbjörn Gräslund (Abstract)

 

Process developent of a serum-free and scalable lentiviral vector manufacturing platform for cellular immunotherapies, Carme Ripoll Fiol, Dale Stibbs, Qasim Rafiq, and John Welsh (Abstract)

 

Expression of anti-apoptotic genes to enhance rAAV production, David C atalán-Tatjer, Saravana Kumar Ganesan, Lise Marie Grav, Ivan Martínez-Monge, and Lars Keld Nielsen (Abstract)

 

Enhancing rAAV production by HEK293 cells via metabolic profiling, Michela Pulix, Vera Lukashchuk, George Prout, Suzanne Podmore, Kevin Bowes, Daniel Smith, and Alan James Dickson (Abstract)

 

Downstream Improvement for Recombinant Adeno-Associated Viruses (rAAV) Produced in iCELLis Nano 4 m2 Adherent Bioreactor, Paromita Majumder, Shannon Young, Paul Cashen, Mark Duncombe, John Welsh, and Kalliopi Zourna (Abstract)

 

Production of a fusogenic oncolytic rVSV-NDV virus: Cell-line screening and process development in small-scale suspension cultures, Sven Göbel, Fabian Kortum, Karim Jaén Chavez, Ingo Jordan, Jennifer Altomonte, Yvonne Genzel, and Udo Reichl (Abstract)

 

Continuous production of lentiviral vectors using a fixed-bed bioreactor, Dale Stibbs, Pedro . Silva Couto, Carme Ripoll Fiol, Qasim A. Rafiq, Nigel B. Jackson, and Andrea C. M. E. Rayat (Abstract)

 

Scaling viral vector production processes into HyPerforma DynaDrive Single-Use Bioreactors, Paula Decaria and Katelyn Parkinson (Abstract)

 

Intensification of viral vector production and clarification by integration of perfusion platforms, Rene Gantier, Rene Gantier, Michael Bransby, Earl Pineda, Joao Mendes, Ricardo Silva, Cristina Peixoto, and Antonio Roldao (Abstract)

 

Impact of intermediate volumes and cell diameters on cell recovery: A predictive model for autologous immunotherapy workflows, Craig Mizzoni, Alena Plotkin, Candace Rhodes, Ala Tobeh, Mojtaba Parvizi, and Rohin Iyer (Abstract)

 

Developing an effective scale-down model for a suspension adapted Hek293t-derived lentiviral vector stable producer cell line, Hamza Patel, Dr Peter Archibald, Professor Martina Micheletti, and Qasim Rafiq (Abstract)

 

Viability enrichment of final drug product using counter-flow centrifugation, Jonathan Lim, Christine Cezar, Ivie Aifuwa, and Vincent Couming (Abstract)

 

Development of cGMP manufacturing processes for the large-scale production of cell-based therapies for commercial applications, Krishna M. Panchalingam, Thomas Richardson, Mehdi Shafa, Tylor Walsh, and Behnam Ahmadian Baghbaderani (Abstract)

 

High-throughput affinity-resin based scale down method for T cell isolation, Marielle Summers, Guy Caspary, Calvin Chan, Sabine Radisch, and Irina Treise (Abstract)

 

Challenges and solutions for allogeneic cell therapy manufacturing, Sunghoon Jung, Brian Lee, Yas Hashimura, Kenny Cruz, Hannah Worden, Kelly Gray, and Breanna Borys (Abstract)

 

Towards an integrated bioprocess for scalable production and isolation of MSC- derived extracellular vesicles for cardiac repair, Marta Costa, António Xavier, Margarida Costa, Enrique Oltra, and Medical Research (Abstract)

 

Developmental lineage of human pluripotent stem cell-derived cardiac fibroblast affects their functional phenotype, Martha Floy, Sophie Givens, Oriane Matthys, Taylor Mateyka, Charles Kerr, Alexandra Steinberg, Ana Silva, Jianhua Zhang, Ying Mei, Timothy Kamp, Brenda Ogle, Todd McDevitt, and Sean Palecek (Abstract)

 

Computational fluid dynamic characterization of vertical-wheel bioreactors used for effective scale-up of human induced pluripotent stem cell aggregate culture, Breanna Borys, Tiffany Dang, Shivek Kanwar, Brian Lee, Sunghoon Jung, and Michael S. Kallos (Abstract)

 

Protocol development to overcome bioprocess bottlenecks in the large-scale expansion of high quality hIPSC aggregates in vertical-wheel bioreactors, Breanna Borys, Tiffany Dang, Sunghoon Jung, Brian Lee, and Michael S. Kallos (Abstract)

 

Virtual reality to rapidly scale a resilient workforce for cell and gene therapy manufacturing, Ivan Wall (Abstract)

 

Induced pluripotent stem cells for candidate cell line selection of off-the-shelf natural killer cell therapy, Jason Mills, Chen-Yuan Kao, Matthew O’Rourke, Barry Morse, Bruno Marques, and Greg Russotti (Abstract)

 

A nature-inspired protocol to generate mature hiPSC-derived hepatocytes: Unveiling the role of human intestinal microbiome, Joana I. Almeida, Pedro Vicente, Pedro M. Baptista, and Margarida Serra (Abstract)

 

Bioprocess optimization for generation of hepatocytes derived from hiPSC and its application in primary hyperoxaluria type 1 disease modelling, Joana I. Almeida, Pedro Vicente, Maren Calleja, Juan Rodriguez-Madoz, Felipe Prosper, Anders Aspegren, and Paula M Alves (Abstract)

 

Manufacturing of patient specific novel T cell therapies using the Cocoon® Platform automated system, Joseph O'Connor, Kalyani Daita, Janet Sei, Eytan Abraham, and Yaling Shi (Abstract)

 

Erbi Biosystems - Cell culture development with a 2 mL continuous perfusion bioreactor, Kevin Lee, Wei-Xiang Sin, Harry Lee, and Michael Birnbaum (Abstract)

 

A scalable bioreactor for the expansion of anchorage-dependent stem cells, Nicholas McMahon, Haruna Easterling, and Kreg Zimmern (Abstract)

 

Proof-of-concept of a novel scalable magnetic bead-based cell separation technology, Nils Brechmann, Kristofer Eriksson, and Véronique Chotteau (Abstract)

 

hiPSC and hiPSC-cardiomyocytes are alternative EV biofactories for cardiac regeneration, Paula Marques Alves, Ana Filipa Louro, Marta Oliveira, Marta Abreu Paiva, Margarida Serra, and Patrícia Gomes-Alves (Abstract)

 

Deterministic cell processing recovers >2-fold more cells, and up to 5-fold more naïve T cells, as compared to centrifugally prepared cells, Tony Ward, Yasna Behmardi, Laurissa Ouaguia, Cole Jones, Hani Rahmo, Alison Skelley, Khushroo Gandhi, and Roberto Campos-Gonzalez (Abstract)

 

Process development and scale-up for gene circuit engineered CAR-NK cell manufacturing, Travis Wood, Dharini Iyer, Wesley Gorman, Carmina Blanco, Abla Bakir, Haritha Lakshmireddy, Charity Vilchez Juang, Denny Nguyen, and Philip Lee (Abstract)

 

Systems-level discovery of quality attributes and candidate pathways for optimized production of human pluripotent stem cell-derived cardiomyocytes, Aaron Simmons, Elizabeth F. Bayne, Yanlong Zhu, Ying Ge, and Sean P. Palecek (Abstract)

 

Development of analytical assays for the characterization of gene circuit enabled cell therapies, Brett Kiedaisch, Mario Lorente, Brandon Lee, Philip Lee, and Nara Vu (Abstract)

 

Transitioning cell-based processes towards scalable production, Isobelle Espiritu, Hanna Rasby, Emily Benz, Kelly Kemp, and Sebastian Rieck (Abstract)

 

Process development for improved Car-t production utilizing an automated perfusion stirred-tank bioreactor, Tiffany Hood, Fern Slingby, Winfred Geis, Viktor Sander, Nicola Bevan, Quentin Vicard, and Qasim A. Rafiq (Abstract)

 

Rapid product characterization for release using membrane microscopy, Adam Ross (Abstract)