ADVANCING MANUFACTURE OF CELL AND GENE THERAPIES VII

An ECI Conference Series

Feb 6-10, 2022
Loews Coronado Bay Hotel
Coronado, CA

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About This Conference

The ECI Advancing Manufacture of Cell and Gene Therapies conference is a biennial meeting that brings together leading figures from academia and industry to showcase and debate the latest breakthroughs in advancing engineering and manufacturing of next generation therapies. 

This 2021 event will provide interactive opportunities for a diverse set of attendees, ranging from trainees to experienced practitioners, to examine the latest advances in product manufacture, analytics, non-viral gene delivery, cell engineering and the future of product release (detailed information on each session provided below).

In addition to these cutting-edge research sessions, this year we are excited to offer an Innovation Hub (think Dragon’s Den / Shark Tank), providing new innovators an opportunity to pitch early-stage disruptive technologies aimed at facilitating advanced therapy manufacture.

Conference Chairs

Sean Palecek, University of Wisconsin, USA 
Damian Marshall, Cell & Gene Therapy Catapult, UK
Fernanda Masri, Sartorius Stedim Biotech, UK

Steering Committee 

Dolores Baksh (Cytiva, USA)
Mike Betenbaugh (Johns Hopkins University, USA)
Tom Brieva (BMS/Celgene, USA)
Barry Buckland, Chair (BiologicB,LLC, USA)
Manuel Carrondo (IBET – Instituto de Biologia Experimental e Tecnológica, Portugal)
Peter Gray (AIBN – University of Queensland, Australia)
Chris Mason (University College London, United Kingdom)
Bill Miller (Northwestern University, USA)
Lars Nielsen (The University of Queensland, Australia)
Rod Rietze (iVexSol, Inc., USA)
Greg Russotti (Century Therapeutics, USA)
Ivan Wall (Aston University, United Kingdom)
Peter Zandstra (University of British Columbia, Canada)

Organizing Committee

Paula Alves, IBET & ITQB, Portugal
Sven Ansorge, ExCellThera, Canada
Stefano Baila, Anemocyte, Belgium
Ricardo Baptista, Procella Therapeutics, Sweden
Nina Bauer, MilliporeSigma, USA
Lorraine Borland, Sartorius, UK
Amit Chandra, YPOSKESI, France
Elizabeth Cheeseman, Independent Consultant, UK
Gisele Deblandre, MaSTherCell, Belgium
Jo Mountford, SNBTS Advanced Therapeutics, Scotland
Clive Glover, Pall, UK
Azadeh Golipour, AVROBIO, USA
Mike Kallos, University of Calgary, Canada
Masahiro Kino-oka, Osaka University, Japan
Todd McDevitt, Gladstone Institutes, USA
Jen Moody, Morphocell, Canada
Qasim Rafiq, University College London, UK
David Schaffer, University of California-Berkeley, USA

Conference Sessions

Session 1: Gene editing and non-viral gene delivery

Session Chairs: 

Ricardo Baptista, Procella Therapeutics, Sweden

Krishanu Saha, University of Wisconsin, USA

Session Scope:

This session focuses on state-of-the-art technologies, technical advancements, and challenges to implementing gene delivery and editing methods that support the manufacture of gene-edited products, including gene therapies and cell-based products for autologous and allogeneic therapies. We invite abstract submissions broadly related to gene editing and delivery, particularly those related to:

  • cellular gene editing methods
  • discovery platforms for attacking known and novel targets more efficiently
  • non-viral vector design
  • non-viral gene delivery modalities
  • chemical, physical, and biological technologies for gene delivery with potential for developing new genetically modified products
  • improving existing products
  • upgrading manufacturing processes

Confirmed Speakers:

In progress


Session 2: Advances in viral vector manufacturing

Session Chairs: 

Sven Ansorge, ExCellThera, Canada

Paula Alves, IBET, Portugal

Session Scope:

Viral vector manufacturing presents a significant bottleneck to further advance cell and gene therapies. This session will provide an overview of current state-of-the art industrial viral vector manufacturing while also highlighting strategies that are currently explored in R&D settings to reduce viral vector capacity constraints currently faced by the field. While the focus is on the main current viral vector workhorses, we welcome presentations on novel modalities and their manufacturing. We invite abstracts submissions broadly related to viral vector manufacturing, particularly those related to:

  • scale-up of manufacturing to meet demand
  • translation of R&D/process development of viral vector production into clinical and commercial manufacturing
  • continuous bioprocessing
  • stable cell line development
  • downstream processing challenges and solutions

Confirmed Speakers:

Keynote: David Schaffer, University of California – Berkeley, USA

Luis Maranga, Voyager Therapeutics, USA

Manny Otero, Turnstone Biologics, USA


Session 3: Advances in cell therapy manufacturing

Session Chairs: 

Jo Mountford, SNBTS, Scotland

Masahiro Kino-oka, Osaka University, Japan

Session Scope:

Many of the emerging technologies in cell production have led to more stable manufacturing processes; however, these have tended to be cell type, or product, specific. It is essential to capture and apply common lessons from these developments to a wider range of products, in particular those that require multi-phase processing with widely differing requirements (e.g. iPSC-derived cell products).  Further, increasingly complex products (combining genetic modification, cell differentiation, etc.) necessitate the development of new manufacturing, monitoring, and analytics technologies that improve process stability, efficiency, and robustness. We invite abstract submissions across the discipline, particularly those focusing on new technologies for: 

  • next generation cell therapies (e.g. iPSCs, T-cells, MSCs and exosomes)
  • upstream and downstream processing (e.g.  integrated closed-process thaw and seeding units
  • cryopreservation and fill/finish processes and equipment, and point of care solutions) 
  • monitoring process stability and cell state/potency (e.g. non-invasive assessments)  
  • product comparability (e.g. in vitro assay for critical quality attributes)
  • stability of product quality (e.g. automation, process analytic technologies, quality-by-design)
  • materials and reagents supporting high-yield and stable processes (e.g. cell harvesting, culture media, cell selection)

Confirmed Speakers:

Keynote: Wen Bo Wang, Fate Therapeutics, USA

Allan Dietz, Mayo Clinic, USA

Koji Eto, Kyoto University – CiRA, Japan


Session 4: Analytics and big data

Session Chairs: 

Angela Keightley, BlueRock, Canada

Boyan Yordanov, Microsoft, UK

Session Scope:

As the cell and gene therapy fields continue to advance, we are using larger and more complex data sets to generate a deeper understanding of product quality and to derive control strategies to improve product manufacture.  However, deriving process understanding from big data remains difficult.  This session will explore some of the challenges along the data-to-insights pathway, particularly those related to:

Upstream: How is Big Data Collected?

  • new analytical approaches for cell and gene therapy product characterization (single cell multi-omics, new assay development, critical quality attributes, etc.)
  • new innovations in biosensor technology development (real-time, non-destructive, closed-loop, etc.)
  • application of process analytic technologies
  • in vitro potency assays

Downstream: How is Big Data Stored, Structured and Analyzed? 

  • data standardization and electronic data management systems to support product development and manufacture
  • computational and modelling methods (machine learning/artificial intelligence, support vector machines, Bayesian, statistical methods, etc.) to support product and process characterization
  • data integration, meta-analyses for improved process understanding, control, and CAPAs (corrective action/preventative action)

Confirmed Speakers:

In progress

Session 5: The future of product release

Session Chairs: 

Lorraine Borland, Sartorius Stedim Biotech, UK 

Azadeh Golipour, AVROBIO, USA

Session Scope:

Whilst bioproduction methods and in-process analytics become ever more complex for cell and gene therapy products, regulatory lot release remains highly dependent on traditional testing approaches. In order to meet our industry needs for the rapid release of these products whilst meeting regulatory standards we must look to new quality control strategies and innovative methodologies. In this session we will explore the regulatory challenges, our current limitations and technology gaps and how we can address these points. In this session, we invite abstracts that address topics such as:

  1. limitations and challenges facing early developers for regulatory lot release
  2. current rapid testing methodologies and successful implementation for lot release
  3. assay miniaturization and automation solutions
  4. translation of R&D/academic assays to industrial GMP-compliant lot release
  5. qualification of meaningful potency assays 
  6. novel rapid testing modalities (or timeframe shortening of existing ones)

Confirmed Speakers:

In progress

Pre-Conference Workshop

Workshop chairs:

Thomas Heathman, HitachiChemical, USA

Nina Bauer, MilliporeSigma, USA

Carolyn Yeago, Georgia Tech, USA

ECI Pre-Conference Workshop

How Can Analytics Enable Manufacturing Automation, Process Robustness, and Deliver Patient Access to Life-Saving Cell-Based Therapies?

Background

Cell-based therapy manufacturing is a complex, often manual, time- and labor-intensive process. As a consequence, price tags remain high, and treatments are only available to a select few. While the focus is typically on manual labor and lack of automation, product understanding is another component that contributes to the complexity. For true process automation to enable scalability in the cell-based therapy industry, analytical methods must be developed and implemented that have a path to becoming fully integrated into cell-based therapy manufacturing processes. 

Overview

In this workshop, you will learn from and work with preeminent industry and academic experts to assess the role testing and analytics will play in enabling next-generation cell-based therapymanufacturing.

This will be approached in four consecutive sessions:

1. Lessons from Past Experience: Learning from the previous biopharmaceutical industries (e.g. monoclonal antibody industry) to identify core gaps in establishing efficient testing and characterization paradigms for cell-based therapy products.

2. Solutions and Technologies: Identifying existing and emerging technologies to address these gaps in the mid-term and explore application to product characterization and drug discovery.

3. Impact Assessment: Assessing the integration of routine testing and manufacturing automation and discussing next steps in process and analytical optimization and standardization.

4. Building a Roadmap: Defining a development plan and identifying appropriate industry and academic sectors for enablement of the generated solutions. 

Audience and Outcomes

The workshop is aimed at members of the cell-based therapy industry at all levels of technical expertise that want to understand and discuss the role of analytical methods in enabling manufacturing automation. Bringing together a broad range of backgrounds and experiences will help the attendees to develop a deeper understanding of cell-based therapy product testing. Through case study-led workshops, the participants will assess the current state of the cell-based therapy industry and work jointly on a roadmap for implementing analytical methods that will enable manufacturing automation based on profound product understanding.

Confirmed Speakers

Coming soon.

Innovation Hub

Innovation hub chairs:

Paul Dal Pozzo, Pyrance, USA

Shashi Murthy, Flaskworks, USA

Stefano Baila, Anemocyte, Belgium

Overview:

Do you have a business idea for the Cell and Gene Therapy community and want to develop your approach and find support; yet your strength is science, not business? At this year’s ECI conference, we have you covered with the all-new Innovation Hub. The Innovation Hub provides the opportunity to get out of the traditional science-only forum and pitch your innovative business idea to conference participants from around the globe. The Innovation Hub will help you develop and present your ideas through tools and coaching and ultimately foster new relationships with potential mentors and stakeholders. Visit www.pyrance.com/eci to learn more and sign up for updates on the upcoming launch. 

Note: all submissions will be made public, all teams submitting ideas should be aware that ECI and affiliates offer no protections of disclosed proprietary information.

Call for Abstracts

Coming Soon

Christopher Hewitt Outstanding Young Investigator Award

Nominations are closed and we are awaiting further information.

Venue Information

The conference will take place at Loews Coronado Bay Hotel (4000 Coronado Bay Road, Coronado, California).  Set on Coronado Bay directly across the street from Silver Strand State Beach, the hotel is just over two miles to San Diego National Wildlife Refuge Complex. The hotel is set on a 15-acre peninsula with beach access via a pedestrian underpass.  The multi-building, three-floor resort offers 439 rooms and suite that are light and airy. Room views include bay, marina, pool or gardens. There is free Wi-Fi and the rooms have Keurig coffeemakers and ample outlets. The hotel has tennis courts, bicycle rentals, a fitness center, spa and three swimming pools.  Both self and valet parking are available for an additional fee.

San Diego attractions such as the San Diego Zoo, Balboa Park and the Gaslamp Quarter are each approximately a 25 minute trip from the hotel.

Sponsor Packages

General Information about ECI

Engineering Conferences International (ECI) is a not-for-profit, global engineering conferences program, originally established in 1962 that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

The format of the conference provides morning and late afternoon or evening sessions in which major presentations are made. Poster sessions will be scheduled for evening discussion as well. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. This format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

All participants are expected both to attend the entire conference and to contribute actively to the discussions. The recording/photographing of lectures and presentations is forbidden. As ECI conferences take place in an informal atmosphere, casual clothing is the usual attire.

Smoking is prohibited at ECI conferences and conference functions.