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Abstract: End-user insights have been deployed to improve the Xcellerex bioreactor platform design space with incremental feature release strategies, focusing on performance. Additionally, scale-up is a multifactor approach requiring intensive knowledge of the engineering characterization for a bioreactor and cell line. GE will present updated data to correlate CPP and CQA from microbioreactors to Xcellerex bioreactors using HyClone cell culture media. : End-user insights have been deployed to improve the Xcellerex bioreactor platform design space with incremental feature release strategies, focusing on performance. Additionally, scale-up is a multifactor approach requiring intensive knowledge of the engineering characterization for a bioreactor and cell line. GE will present updated data to correlate CPP and CQA from microbioreactors to Xcellerex bioreactors using HyClone cell culture media.
Yasser Kehail, Bioprocess Hardware Applications Leader, GE Healthcare
Yasser Kehail has over 10 years’ experience in cell culture manufacturing, development and optimization, and currently serves as the Bioprocess Hardware Applications Leader for GE Healthcare in the Life Sciences division. For the past 5 years, he has been responsible for supporting customers working in different therapeutic modalities, using various expression systems based on Xcellerex systems. Yasser has a Bachelors degree in genetic engineering from Jordan University of Science and Technology, and received his Masters degree in Bioprocessing from Northeastern University. Yasser began his career at Biogen in cell culture manufacturing, and then moved to Upstream PD at Amgen, before joining GE Healthcare.
Chor Sing Tan, Senior Upstream Bioprocessing Applications Leader, GE Healthcare
Chor Sing is the Senior Upstream Bioprocessing Applications Leader in GE Healthcare’s Life Sciences business. In this role, Chor Sing provides leadership and strategic guidance to the Bioprocess business. His main area of expertise is in single-use bioprocessing technologies. Prior to his current role, Dr. Tan served in several business and science functions for GE including sales, marketing and scientist roles in bioprocess technologies involving modular manufacturing solutions, bioreactors, chromatography, protein expression and filtration. Chor Sing studied chemical engineering at the University Sains Malaysia. He received both his Masters and Ph.D. degrees in chemical engineering from the University of Melbourne.
Andreas Castan, Principal Scientist, GE Healthcare
Andreas Castan is an R& scientist for GE Healthcare’s Life Sciences business. In this role, Andreas provides leadership and support to the Bioprocess business. His main area of expertise is in upstream processing. Prior to joining GE Healthcare, Andreas was Director Upstream Development at Swedish Orphan Biovitrum AB, working with development of expression systems, process development of microbial and mammalian cell-based processes, and scale-up to cGMP manufacturing scales. During the last 20 years, Andreas has held several positions within biopharmaceutical development, including project and line management as well as manufacturing. Andreas studied chemical engineering at the Technische Universität Hamburg (TUHH), Germany. He received a Ph.D. in Biochemical Engineering at the Royal Institute of Technology (KTH), Stockholm. Andreas Castan, Principal Scientist, GE Healthcare
Featuring: Shannon S Eaker, PhD, Cell Therapy Tech Sales Leader, Enterprise, GE Healthcare
Track: Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Date: Wed, Sep 11
Time: 12:00 PM
Abstract: As cell and gene therapy processes turn to scalable manufacturing processes, many organizations are learning from previous bioprocess advances in automation and digitization. Adding these advances early in Process Development (PD) activities can provide speed and efficiency when entering technology transfer, clinical trials and commercial manufacturing. Knowledge and expertise from bioprocess learnings in eSOP’s, eBR’s, and facility dashboards can streamline processes, while reducing labor and risks when producing cellular therapies.
Bio: Shannon received his PhD from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is around T-cell, HSC, and ES/iPSC cell biology, and has been with GE Cell Therapy for over 7 years. He is a member of the International Society for Cell Therapy (ISCT) Process and Product Development (PPD) committee, and has authored numerous papers within the field of cell biology and manufacturing. He is currently the Technical Leader within GE's Cell Therapy Enterprise Solutions group. Shannon lives with his wife and 2 children in Knoxville, TN.
Featuring: John S. Schreffler, PhD, Principal Scientist, Biotherapeutics Development, Janssen
Track: Track recovery & purification
Date: Tue, Sep 10
Time: 2:30 PM
Abstract: New bioreactor technologies are challenging current protein A resin capabilities. Experiments were performed to characterize a higher productivity Protein A fiber matrix. The utility of this matrix, along with other advantages, especially at certain points in clinical life cycle, were evident and will be summarized. Potentials and challenges of implementation at larger scales will also be discussed.
Bio: John has 17 years of experience as a process development scientist, working at companies such as WuXi, Amgen, Morphotek, and for the last four years as a principal scientist for Janssen.
Presenter: Helena A.M. Öhrvik, PhD, Scientist, R&D BioProcess, GE Healthcare
Track: Technology workshop
Date: Wed, Sep 11
Time: 2:45 PM
Abstract: Biopharmaceutical productivity and flexibility can be increased by combining single-use technology, in-line sensors, and automated process control. In this study we combined these tools to enhance process control by feedback loops, further reducing manual handling and increasing process robustness. Here, we demonstrate the flexibility of using the single-use Xcellerex XDR10 bioprocessing system, an integrated in-line sensor for real-time monitoring and automated in-process control. First, the in-line InCyte probe was used to monitor the viable cell density and control a steady state perfusion via an automated feedback loop controlling the pump for cell bleeding. Viable cell density data was processed with Wonderware™ automation software to accomplish a steady state perfusion by cell bleeding. Second, we combined N-IR in-line monitoring with a feedback loop for glucose control to obtain a fully automated control of this nutrient. At the same time, we received real-time data for lactate, viable cell density, and IgG concentration. The N-IR spectroscopy data was processed in real time, and predicted nutrient concentrations were communicated to the Wonderware software, which controlled a pump on the XDR system. In summary, our data supports use of in-line sensors for better process control in upstream applications. With the thoughtful configuration of sensors and automation software to control multiple process parameters, the XDR system offers flexibility and enhanced in-process control.
Bio: Helena Öhrvik is Scientist at GE Healthcare Life Sciences R&. After receiving her Ph.D. in Pharmacology in Uppsala, Sweden, she moved to North Carolina, US, to do her post-doctoral training at Duke University. Her research involved the expression and regulation of recombinant membrane bound proteins in cell cultures. Since Helena joined GE, she has focused mainly on continuous processes, including perfusion, and new inline technologies for the bioprocess field.
Featuring: Laura A. Adamson-Small, Director, Upstream Process Development, Homology Medicines Inc.
Track: Speed from gene to market
Date: Thu, Sep 12
Time: 9:15 AM
Abstract: Homology Medicines has identified 15 novel Clade F rAAVs derived from human hematopoietic stem cells (AAVHSCs). The optimal manufacturing platform was evaluated by comparing the Sf9-baculovirus and HEK293 transfection systems. Both methods were evaluated for productivity, product quality, and in vivo efficacy. HMI has developed a Manufacturing Platform that is transfection-based, linearly scalable and demonstrated up to 500L in a serum-free, suspension system.
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, GE Healthcare introduced Chronicle - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare in 2013 during which time has been an active involvement in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development of GE’s products and services into the C> space.
Featuring: Vimal Vaidya, Senior Associate Scientist II, Downstream Vector Process Development, bluebird bio
Track: Gene-editing track of the Focus Day
Date: Fri, Sep 13
Time: 10:00 AM
Location: Harborview room on Plaza Level
Abstract: Automation of viral vector ultrafiltration/diafiltration (UF/DF) processes is desirable as it increases process robustness. Given the smaller batch volumes of viral products and the limited availability of equipment with single-use flow paths, it has been challenging to translate manually operated processes to currently available equipment. In this work, we present an automated, UF/DF method for lentiviral vector production.
Bio: Vimal is a Senior Associate Scientist in the Downstream Vector Process Development group at bluebird bio. At bluebird bio, he is focused on developing and implementing vector purification processes to support their clinical and commercial programs.
Abstract: CAR-T therapy shows great promise for treating hematologic malignancies, and there is a growing need for bioprocess workflow solutions supporting industrial scale-up and scale-out of these therapies. Challenges to overcome in the CAR-T manufacturing process include lengthy production times (11-21 days), product variability associated with open handling steps, and high manufacturing costs. Here we examine and evaluate individual CAR-T cell unit operations, commercial reagents, and equipment with process closure potential to develop an improved workflow and increase product consistency.
Optimize | Simplify | Analyze
Process intensification lets you maximize product, while minimizing one or more key variables of your current manufacturing process.
Chronicle automation software provides a unified digital platform to monitor cell therapy facility manufacturing operations and supply chain logistics.
With the right tools and support you can balance innovation, speed, and robustness in your late-stage process development.