Advancing future therapeutics
Biotech Week Boston

September 9-13, 2019
Boston MA

BPI East & CAR-TCR Summit
Reimagine capacity at Biotech Week in Boston

Speed and efficiency are critical elements of a biomanufacturing strategy, and the right supplier can contribute to your business success. Discover how optionality minimizes capital investment risks, and dramatically increases speed to market. Engage with GE to gain access to our industry expertise and insights that boost productivity, increase output, strengthen performance, and speed results.

Register today to connect with one of our experts at:

  • BPI East - Booth #618  or
  • CAR-TCR - Booth #28 

Elevated and flexible

Explore automated flexibility in an interactive environment and see how quickly we can address your needs.
Take the digital challenge and discover elements of an integrated platform that delivers improved efficiency for your individual process to an entire facility.

BPI East - Lunch and learn panel discussion
Strategies and multi-factor approaches for bioreactor scale-up

 Tue, Sep 10     12:20 PM–1:25 PM    205B

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.

Featured panelist:

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.

Panelists:

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

Yasser Kehail, Bioprocess Hardware Applications Leader, GE Healthcare

BPI East
Sponsored presentations:

Bridging cell and gene therapy process development with next generation automation

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
Location: 203

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.

Shannon S Eaker

Comparison of protein A fiber and intensified protein A resin processes

Featuring: John S. Schreffler, PhD, Principal Scientist, Biotherapeutics Development, Janssen
Track: Track recovery & purification
Date: Tue, Sep 10
Time: 2:30 PM
Location: 210B

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.

John S. Schreffler

Real-time control executed by in-line sensing

Presenter: Helena A.M. Öhrvik, PhD, Scientist, R&D BioProcess, GE Healthcare
Track: Technology workshop
Date: Wed, Sep 11
Time: 2:45 PM
Location: 209

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.

Helena A.M. Öhrvik

Scalability of a transfection-mediated GMP production platform for novel Clade F rAAV vectors

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
Location: 209

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.

Laura A. Adamson-Small

BPI East
Technical posters

Burgeoning Progress in Bioprocess Intensification

There have been a rising interest in the past decade in finding smart and efficient ways to improve the overall output of bioprocesses which can be referred to Bioprocess Intensification. Many goals often considered in this particular term of Bioprocess Intensification include making the process cleaner, cheaper, smaller, more efficient, safer and faster. For bioprocesses this could include but not limited to higher cell density and viability, manufacturing flexibility, sustainability, higher product quality and more. We define here bioprocess intensification in a more limited scope as “technologies to increase the amount of intermediate or final product manufactured per volume, footprint, unit of time, or expense”. It appears that even this may be realized through improvement in quite a few distinct facilities styles, process steps, raw materials or process equipment. Note that this is not to diminish the novelty or import of such other exciting initiatives as digital recordkeeping, novel MES/ERP, advances in product quality monitoring, or new assurances of raw material supply and quality. But, even when we constrain the concept of bioprocess intensification to only those innovations which will increase some aspect of the productivity, or production efficiency, of a biomanufacturing facility– we see a number of distinct technologies are emerging to support it. They range from increasing the specific productivity of the platform microbial or mammalian/insect cell-line, to any number of improvements in the facility, process, operation or materials. We will discuss bioprocess intensification as a component the next-gen manufacturing, factory of the future and smart bioprocessing programs, as well as in the context of the factory-in-a-box, continuous biomanufacturing and biopharm 4.0 initiatives.

Reduce risk of failure in virus clearance studies using robust scale-down chromatography tools

To evaluate the viral safety of a biopharmaceutical, a viral clearance study is usually performed for specific steps of the process to validate that the production process can inactivate/remove virus contamination. These studies are often cost and time consuming, so any risk of failure should be prevented.
There are important parameters to consider when selecting your column for studying viral clearance of a chromatography process step. To ensure robust and reproducible viral clearance studies, hence reduce risk of failure, the column should:
  • Be an appropriate scale-down model to properly mimic large-scale viral clearance, while reducing the use of sample and resin, hence lower costs for the study. A column with same resin bed height as in manufacturing, and smaller inner diameter is commonly used.
  • Feature high-quality packing to provide robust and reproducible results.

A new empty column (HiScale 10/40) and prepacked Validation columns are available from GE Healthcare Life Sciences to support robust scale-down studies. We show results from a viral clearance study using the HiScale 10/40 column, packed with MabSelect™ PrismA affinity chromatography resin, performed by a collaborator. The reduction factor, ~ 2.5 log reduction value, was in the typical range for a protein A affinity chromatography step, thus demonstrating a good removal and a robust process.
The new HiScale 10/40 column is suitable to mimic the effectiveness of the manufacturing virus removal processing steps. The column’s 10 mm inner diameter and flexible bed height helps minimize the use of sample, virus, and resin while keeping the same conditions as in large-scale processes.
The prepacked Validation columns are a scale-down version of a commonly used bed height in large-scale chromatography process steps (20 cm bed height, 10 mm i.d.). The Validations columns have been developed and tested together with biomanufacturers. Our results show that the Validation columns provide high consistency between columns in terms of HETP and asymmetry making them a suitable choice for scale-down studies.

Scale-up model of a mAb process from microbioreactor to XDR-1000

The transfer of a process between scales, often referred to as scale-up or scale-down, is a difficult task. Multiple scaling criteria exist and intensive knowledge of the physical characterization parameters for a bioreactor are required to facilitate this adjustment.
In this study, we have leveraged existing physical characterization data and scaled a process from microbioreactor to production scale in XDR-1000. We show physical operating parameters and present both cell culture and product quality data across all scales. The presented data sets demonstrate the scalability from microbioreactors to Xcellerex bioreactors and across the XDR platform.

CAR-TCR - Plenary session
Maximize your PD and manufacturing capabilities

Featuring: George White, Product Strategy Manager, Cell & Gene Therapy, GE Healthcare

Thu, Sep 12     09:30 AM    Commonwealth Complex (room behind exhibit hall)

Abstract:
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.

Bio:
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&GT space.

Yasser Kehail, Bioprocess Hardware Applications Leader, GE Healthcare

CAR-TCR
Presentation and poster:

Presentation
Development of an automated ultrafiltration/diafiltration step for lentiviral vector

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.

Vimal Vaidya, Senior Associate Scientist II, Downstream Vector Process Development

Poster
Moving towards a closed CAR-T cell manufacturing process

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.

Showcase

Intensified Process

Optimize | Simplify | Analyze
Process intensification lets you maximize product, while minimizing one or more key variables of your current manufacturing process.

Learn more

Automated manufacturing

Chronicle automation software provides a unified digital platform to monitor cell therapy facility manufacturing operations and supply chain logistics.

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Accelerate process development

With the right tools and support you can balance innovation, speed, and robustness in your late-stage process development.

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