Corporate Program

Corporate Symposium Hosted by Miltenyi Biotec

Emerging technologies and clinical advancements in cell therapy

Wednesday May 2
16:30 – 18:30
Room 520CF

Chair:
Neehar Bhatia, PhD, Stanford School of Medicine, United States

Speakers:
First clinical trials utilizing the automated CliniMACS Prodigy® TCT process
Claire Roddie, PhD, UCL Cancer Institute, United Kingdon
CAR T cell production at the Conconi Family Immunotherapy Lab using the CliniMACS Prodigy platform
John Webb, PhD, British Columbia Cancer Agency, Canada
Adoptive T cell therapy: Enabling technologies for clinical trials
Cassian Yee, Prof, MD, The University of Texas MD Anderson Cancer Center, United States
CAR T cells: progress and challenges
Crystal L Mackall
, Prof, MD, Stanford University, United States

The Symposium will focus on clinical application and development of cell therapies.

Corporate Symposium Hosted by Novartis Pharmaceuticals

What Makes CARs Work? – A look under the hood

Thursday May 3
17:15 – 19:15
Room 517D

Reception begins at 17:15.  Catering provided courtesy of Novartis. 

Chair:
Marcela Maus, MD, PhD, Massachusetts General Hospital, Boston, United States

Speakers:
John Bell, PhD, Ottawa Hospital Research Institute, Canada
Abhijit Chakraborty, PhD, Novartis Pharmaceuticals, United States
Marcela Maus, MD, PhD, Massachusetts General Hospital, United States
Bijal Shah, MD, Moffitt Cancer Center, United States

This satellite symposium will serve as a forum in which the panelists will discuss key attributes of emerging chimeric antigen receptor (CAR) T-cell therapies, including

  • Contribution of various CAR domains to the efficacy and safety of CAR T-cell therapies
  • Current understanding of CAR T-cell cellular kinetics in hematologic malignancies
  • Role of lymphodepleting chemotherapy, mechanisms of resistance, and predictors of response, relapse, and safety

Corporate Lunch Tutorial Hosted by BD Biosciences

Improving Cell Therapy Production with standardized and consistent Flow Cytometry Assays and sterile fluorescence activated cell sorting

Thursday May 3
12:30 – 13:30
Room 518BC

Speaker:
Scott Bornheimer, PhD, BD Biosciences, United States

Cells are frequently characterized during cell therapy production to track important subsets for research, process monitoring and QC for final release.  Standardized flow cytometry assays that perform consistently across time, operators, instruments and sites are critical in this regard.  BD will present technology and methods to meet these needs, based on IVD systems adapted for use in self-validated GMP cell processing.  Consistency in cell starting materials, including isolation of target cells and removal of non-beneficial cells, is also important for consistent cell therapy production. Fluorescence activated cell sorting (FACS) can isolate cell subsets based on quantitative expression of multiple markers with excellent purity, viability and yield.  We will highlight the current use of FACS in GMP cell processing applications and present technologies for sterile, closed and easy-to-use FACS to facilitate future use.

Corporate Lunch Tutorial Hosted by Macopharma

The first clinical grade virally inactivated human platelet lysate, MultiPL’i: a powerful, safe and standardized alternative to FBS to expand cell therapy products.

Friday May 4
12:30 – 13:30
Room 518BC

Chair:
Bruno Delorme, PhD, Macopharma, France

Speakers:
Bruno Delorme, PhD, Macopharma, France
Andrew Finnerty, Centre for Cell Manufacturing, Ireland
Sabrina Viau, PhD, Macopharma, France
Jorge Burns, PhD, University Politehnica of Bucharest, Romania

Human platelet lysate (hPL) represents a powerful xeno-free alternative to fetal bovine serum (FBS) for human mesenchymal stem cell (hMSC) expansion. However, the characterization and the batch-to-batch standardization of such products still remain a challenge. In addition, the general chapter 5.2.12 of the European Pharmacopeia requires the addition of a step of viral inactivation during the production process of such raw material of biological origin used for cell-based and gene therapy medicinal products.

We will report the extensive characterization and document the robust standardization of our different clinical grade hPL products (MultiPL’), including growth factors (GF) contents, multiplex assay and biochemical and proteomic analysis. Data of comparison of hMSCs cultured with either FBS or MultiPL’ will be presented (expansion, morphology, membrane marker expression, potential of differentiation and immunosuppressive properties). We will highlight some key characteristics of hMSC cultured in hPL. Importantly, we will also show that the use of standardized hPL improves the standardization of biological features of hMSCs. Finally, the efficacy of the gamma irradiation to inactivate a broad range of viruses in MultiPL’ will be documented. The impact of the gamma irradiation on MultiPL’ and the biological features of hMSCs cultured in MultiPL’i will be described.

Corporate Breakfast Tutorial Hosted by GE Healthcare

Learning by doing:  Learn from clinical and manufacturing leaders’ through their journey from development to delivery of cellular therapies

Thursday May 3
07:30 – 08:30
Room 518BC

Speakers:
Allan Dietz, PhD, Mayo Clinic, United States
Marcela Maus, MD, PhD, Massachusetts General Hospital, United States
Bruce Levine, PhD, 
University of Pennsylvania, United States

Academic clinical institutions are fueling the remarkable advances in research, development and commercialization of cellular therapies.  This progress is driving the need to adopt cGMP production standards during early development phases. Alongside industry, academic institutions must grapple with ways to assure product consistency, safety, and availability of the product.   In this session panelists will discuss the evolution and challenges faced by clinical centers in their pursuit of developing and delivering new cellular therapies to the patients they serve.

Corporate Breakfast Tutorial Hosted by Roche CustomBiotech

Rapid microbiological methods in meeting unique QC and product-specific validation needs of advanced therapy manufacturing

Thursday May 3
07:30 – 08:30
Room 519AB

Chair:
Evonne R. Fearnot, MSBME, Roche CustomBiotech, United States

Speakers:
Alexey Bersenev, MD, PhD, Yale University, United States
Sowmya Viswanathan, PhD, University Health Network, University of Toronto, Canada

Rapid microbiological methods (RMMs) are essential for state-of-the-art manufacturing efficiency of advanced therapies because traditional testing methods do not provide shorter testing timelines and lower sample volume utilization.  Some advanced therapies involve a manufacturing process and release timeline of just a few days making third-party testing impractical.  There are ways to incorporate RMMs for QC testing, such as using a nucleic acid amplification technique as an alternative mycoplasma testing system after appropriate product-specific validation in-house.  Leveraging available validation data facilitates a regulatory abbreviated qualification plan for RMMs.  Several myths impede advanced therapy manufacturers from adopting these RMMs for QC testing.  This session is intended to dispel these myths with accurate information and real-world experience.

Corporate Breakfast Tutorial Hosted by ASME

Training the Engineering Workforce for Cellular Therapy Manufacturing

Friday May 4
07:30 – 08:30
Room 518BC

Speaker:
Brian Behnke, ASME Learning and Development, United States

Leveraging the talents of skilled engineers working in the cell therapy space remains a challenge for many biopharmaceutical companies. Recognizing that foundational learning and standardization are critical success factors, the American Society of Mechanical Engineers (ASME) has developed a tool to begin filling this need: an introductory cellular therapy manufacturing eLearning course for engineers. Preview this solution that you can use to help educate your current engineering team or onboard your future workforce. Using real world examples and case studies, the course will cover end-to-end cell therapy manufacturing, emphasizing the engineering problems and processes and the critical roles engineers play.

Product Theatre Presentation – GE Healthcare

Simplify upstream and downstream cell therapy processing with GE’s Sefia™ S-2000 system.

Thursday May 3
10:30 – 10:45
Global Product Showcase

Speaker:
Bertrand Foucaut, GE Healthcare – Cell Therapy, Switzerland

Cell processing takes place in a complex environment that poses many challenges. GE Healthcare Life Sciences provides solutions that simplify your everyday operations while maintaining flexibility and performance.

Our newest solution allows you to combine multiple workflow steps. The Sefia S-2000 system is suitable for both upstream and downstream processing. Use the same instrument for both – just select the appropriate combination of protocol software and disposable kits. With one software and kit combination you can prepare apheresis products. Set up the software to run volume reduction, platelet removal, and density gradient-based separation alone or automatically in sequence. With another software and kit combination you can perform downstream operations. Customize the sequence of harvesting, washing, and final formulation operations to fit your workflow needs.

Product Theatre Presentation – MilliporeSigma

Expansion of Human Induced Pluripotent Stem Cells in Suspension Culture

Thursday May 3
10:45 – 11:00
Global Product Showcase

Speaker:
Aletta Schnitzler, PhD, MilliporeSigma, United States

The therapeutic potential of human induced pluripotent stem cells (hiPSCs) is explored in a large array of indications, ranging from acute myocardial infarction to diabetes. The inefficiencies in some current differentiation protocols combined with the large numbers of cells recommended for clinical scale tissue engineering warrant the use of systems that are capable of generating large batches of hiPSCs in a controlled manner. In this study, a stirred-tank 3L bioreactor was used for the final expansion of hiPSCs as aggregates in a system providing pH, dissolved oxygen (DO), temperature and agitation control. Overall, a 125-fold expansion was achieved after a 14 day two-step process. The bioreactor-expanded hiPSCs retained expression of the pluripotency markers and formed tissues of each of the three germ layers.  Moreover, hiPSCs cultured as aggregates were also directly differentiated to therapeutically-relevant cell types including cardiomyocytes.  The results demonstrate the potential of hiPSC production in controlled stirred suspension systems that can support the production of large batches of cells for research and clinical applications.

Product Theatre Presentation – Beckman Coulter Life Science

Get Lean: Streamlining Single Cell Analysis Workflow

Thursday May 3
12:30 – 12:45
Global Product Showcase

Speaker:
Marilyne Levadoux-Martin, PhD, Beckman Coulter Life Science, Canada

While Flow Cytometry has been a core technology for advancing scientific research in cellular therapy, constant innovation is necessary to eliminate inefficient workflows, sources of variability and user introduced errors. Beckman Coulter’s disruptive technologies are uniquely positioned to reshape your workflow without compromising data quality or compliance.

With Beckman Coulter’s Complete Workflow Solution you can have:

  • Consistent assay results by using our proven dried down antibody panels with DURAClone Reagents
  • Outstanding sensitivity and electronic record management with the CytoFLEX Flow Cytometer Platform
  • Traceable analysis and reporting through user management and LIS integration with Kaluza Analysis Software
  • Automated staining protocol, from sample preparation through analysis, by directly integrating a CytoFLEX analyzer with a Biomek i-Series Liquid Handler

Product Theatre Presentation – CCRM

Developing closed and integrated processes for cell therapy manufacturing

Thursday May 3
12:45 – 13:00
Global Product Showcase

Speaker:
Aaron Dulgar-Tulloch, PhD, BridGE, GE Healthcare, Canada

As cell and gene therapies advance towards market approvals, there is a need for robust manufacturing solutions that are suitable for commercial scale production. Many cell manufacturing processes are currently being carried out with manual handling steps in an open manner, putting them at high risk for process variability. Our team is developing processes suitable for commercial scale manufacturing for both scale-up and scale-out cell production. As an example, we have demonstrated closure and integration of a T-cell production process by: automating the processing of input fresh and frozen apheresis units; closing both small- and large-scale T-cell culture using gas permeable bags and the Xuri™ W25 Cell Expansion System; and integrating cell culture and downstream harvest, wash, and formulation using the Sefia™ Cell Processing System. We have demonstrated a similar conversion from manual tissue culture to a closed and integrated bioreactor-based manufacturing of scaled-up pluripotent stem cells in a 10 L stirred tank reactor. With these strategies we are providing cell manufacturing solutions that can be readily adapted to a variety of customer-specific processes.

Product Theatre Presentation – Miltenyi Biotec

Automated clinical-scale manufacturing of gene-engineered T cells using the CliniMACS Prodigy

Thursday May 3
13:00 – 13:15
Global Product Showcase

Speaker:
Michael Papadimitrious, Miltenyi Biotec, Germany

For over 25 years, Miltenyi Biotec has been providing technologies spanning the entire workflow of cell therapy, with solutions applicable from basic research to GMP manufacturing. The CliniMACS Prodigy is a cell manufacturing platform – one instrument that automates the handling steps in a single-use disposable tubing set. The example of a chimeric antigen receptor (CAR) T cell manufacturing process will be presented, demonstrating an integrated solution for cell selection, activation, transduction, and expansion.

Product Theatre Presentation – Be The Match BioTherapies

Auditing, onboarding, and managing apheresis and marrow collection networks to support late-stage clinical study and commercial launch of cell and gene therapies

Thursday May 3
13:15 – 13:30
Global Product Showcase

Speaker:
Chris McClain, Be The Match BioTherapies, United States

One of the major obstacles faced by developers of emerging cell and gene therapies is providing reliable, nationwide access to apheresis and marrow collection centers. Over the course of its 30 year operating history, the National Marrow Donor Program (NMDP)/Be The Match has built and managed a national network of more than 80 apheresis centers and 70 collection centers. Through that network, NMDP/Be The Match has managed more than 74,000 stem cell harvests. Be The Match BioTherapies, a subsidiary of NMDP/Be The Match, will describe solutions that it provides to developers of cell and gene therapies to support late-stage clinical development and commercialization of therapies that rely on stem cell harvest for therapeutic starting material.

Product Theatre Presentation – Irvine Scientific

Chemically-Defined Culture Media for Advancing Cell-Based Immunotherapy Technology

Thursday May 3
15:15 – 15:45
Global Product Showcase

Speaker:
Jessie Ni, PhD, Irvine Scientific, United States

Cell-based immunotherapy applications are widely captivating today due to their clinical potential to become life-saving therapies for cancer patients. Generation of sufficient, desired cell populations is an essential task for the successful development of cell-based immunotherapies, which require an effective, scalable, and consistent ex vivo process. A suitable chemically-defined (CD), animal-component-free (ACF) cells basal media for major immune cells, such as T-cells and natural killer (NK) cells, would significantly foster the establishment of such a process. By applying spent media analysis and the quality by design (QbD) approach, we examined the effects of various key media compositions such as amino acids, vitamins, minerals, and lipids on activated human peripheral blood-derived T-cell or NK cell expansion. The results from our studies were used to develop CD, ACF basal expansion media for desired T-cell and NK cell populations that are comparable to media containing serum, and further indicate the need to develop cells- and application-specific basal media to establish an optimal production process for a desired/targeted immune cell-based therapy under CD conditions.

Product Theatre Presentation – BioLamina

CTG BioLamininTM 521 – a biologically relevant culture matrix, enabling pre-clinical research protocols to be translated and used for clinical trials.

Friday May 4
10:15 – 10:45
Global Product Showcase

Speaker:
Therese Kallur, PhD, BioLamina, Sweden

As an extension of our portfolio of hr laminin cell culture substrates, we now offer a cell therapy grade (CTG) laminin-521 matrix (BioLamininTM 521) for use in research and manufacturing of Cell, Gene, or Tissue-Based Products.

CTG BioLaminin 521 is xeno-free and provides a defined surface for feeder-free culture of human pluripotent stem cells (ESC and iPSC), MSCs, most anchorage-dependent progenitors and differentiated cells such as RPE, hepatocytes, cardiomyocytes and neurons.

CTG BioLaminin 521 recreates a biologically relevant milieu in vitro, promoting high survival and robust single-cell or colony expansion of human pluripotent stem cells, and subsequent cell lineage specification. The cells grow with maintained pluripotency, genetic integrity in a homogeneous monolayer, easy to monitor and maintain.

The substrate is robust, flexible and compliant with any culture medium and protocol. It allows an operator-independent culture maintenance and reliable, standardized protocols which can easily be adapted to automation platforms.

CTG BioLaminin 521 is produced according to FDA and EMEA guidelines (USP <1043>) and is aimed to be an ancillary material in the manufacturing cell products for therapeutic use. It is designed to aid users in the qualification process of raw material.

Product Theatre Presentation – Cook Regentec

Different Makes The Difference: The CellSeal® System

Friday May 4
12:30 – 13:00
Global Product Showcase

Speaker:
Sean Werner, PhD, Cook Regentec

The CellSeal® System aims to fill the industry’s need for a cryogenic storage and recovery process. For storing, it is a solution for leakage, breakage, and contamination in cryogenic storage. For packaging, it is a solution for consistent small-batch sealing and automated large-batch filling and sealing. For thawing, it is a solution for standardizing the thawing process through customizable profiles. Through these solutions, we will demonstrate how the CellSeal platform leads to significant gains in processing scale-up, quality, and standardization for cell and gene therapies.

Product Theatre Presentation – CellCAN

More than 4800 days of a wonderful second life! William Brock’s inspiring story!

Friday May 4
13:00 – 13:15
Global Product Showcase

Speakers:
William Brock, Davies Ward Phillips & Vineberg LLP and CellCAN Board of Directors, Canada
Craig Hasilo, PhD Candidate, CellCAN, Canada

Diagnosed in September 2004 with acute myelogenous leukemia, the Montreal lawyer William Brock thought he had just received a death sentence with very little time left to live. Within his own city of Montreal, he discovered a true gem in advanced healthcare: a centre where stem cell transplantation and cell therapy were provided at the highest standards. Shocked to learn that such cutting edge technology existed in Canada, Mr. Brock sought a referral and immediate treatment that would forever change his life and that of everyone around him.

Product Theatre Presentation – CellCAN

How well do you know Canada’s cell & gene manufacturing landscape?

Friday May 4
13:15 – 13:30
Global Product Showcase

Speaker:
Craig Hasilo, PhD Candidate, CellCAN, Canada

Canada is known for its excellence in research, outstanding publication record on cell & gene therapies and our collaborative culture. Our thriving RMCT ecosystem is on the brink of a major expansion. At the core of our strengths lie our expertise in cell & gene therapy manufacturing for early and later-phase multicenter clinical trials or commercialization efforts. But how well do you know what Canada has to offer in terms of manufacturing capacity? To what extent do Canadian cell & gene therapy manufacturing centres collaborate?

In this interactive session you will learn more about CellCAN’s cell & gene manufacturing facilities and transversal cores, and how they share best practices through a collaborative online platform to improve the quality, safety and feasibility of cell & gene therapies. This unique collaboration will ultimately increase the capacity to rapidly and effectively migrate innovative treatment concepts into standard clinical practice.

Product Theatre Presentation – AventaCell BioMedical Corp. Ltd.

What’s New with Human Platelet Lysates?

Friday May 4
15:15 – 15:30
Global Product Showcase

Speaker:
William Milligan, AventaCell BioMedical Corp., Ltd., Canada, United States, Taipei

Human platelet lysates are now broadly used to replace FBS and early serum-free supplements for the isolation, expansion and production of multiple cells including; AD MSC, UC MSC, BM MSC, CIK, NK, dendritic cells, and primary tissue cell lines. AventaCell’s UltraGROTM line offers hPL and fibrinogen-depleted hPL (FD hPL) options in both RUO and GMP grade supplements. UltraGROTM GMP products are used in cell therapy research and clinical development. Pathogen reduction will soon be available in GMP UltraGROTM products to better meet regulatory requirements and expand clinical development applications. UltraGROTM supplements have also been shown to effectively replace FBS and serum-free supplements for MSC expansion in bioreactors including; micro-carrier spinner flask bioreactors and the Quantum bioreactor (2016 & 2017 publications).  We’re also introducing UltraKURE – NK this year, our first hPL-based kit for NK cell expansion. For more product information, samples, and new developments, please come visit us in Booth #320.

Corporate Master Class – Thermo Fisher

Identifying a lentiviral production platform to achieve cost-effective scalable manufacturing

Friday May 4
17:15 – 17:45
Global Product Showcase

Speaker:
Calley Hirsch, CCRM, Canada

Lentiviral vectors are gaining increasing momentum as a preferred genetic delivery tool for cell and gene therapies. Manufacturing lentivirus for advanced therapeutics has long centered around transient transfection of adherent cultures for vector production, however, these methods invariably suffer from scale-up, labor, cost and consistency challenges. As an approach to circumvent these problems, transient transfection of suspension cells has been proposed. In this presentation, a lentiviral production screen will be discussed where two GMP accessible suspension cell lines were paired with different media and transfection reagents to identify a lentiviral vector platform that consistently yields the highest titer and lowest production cost. Based on these finding, internal scale-up efforts are ongoing to develop a readily adaptable cGMP lentiviral manufacturing process.