Scale-up and Manufacturing of Cell-based Therapies V

An ECI Conference Series

January 15-19, 2017
Hyatt Regency Mission Bay Hotel
San Diego, California

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About This Conference

There is tremendous clinical promise for emerging therapies based on administrating cells to patients to treat a diverse assortment of diseases.  However, the complexity of cells that affords great therapeutic promise also increases the complexity of their manufacture and testing.  Furthermore, there are distinct challenges for the many forms of cell products (e.g., autologous vs. allogeneic, fresh vs. frozen).  The ability to manufacture and perform assays that confirm the quality of cell products will be critical factors in the anticipated success of cell-based therapies.  In particular, it is necessary to develop manufacturing processes that are scalable, cost-effective, and reliable, along with measurements of cell characteristics that are pertinent to product quality.  This conference focuses on the engineering and pragmatic approaches required to develop, refine, characterize, scale-up, automate, validate, and commercialize processes and assays to manufacture, test, store, and distribute cell-based therapies.

Technical Sessions
(May 18, 2016)

Technical Session 1:  Upstream and downstream process characterization, scale-up, comparability, and in-line process monitoring

Session co-chairs:  Joaquim Cabral (University of Lisbon) and Fran Meacle (Johnson & Johnson)

Invited speakers:  Sakis Mantalaris (Imperial College London) and Michelle Kreke (Capricor)

Description:  As an increasing number of cell therapies start to demonstrate proof-of-concept in early phase clinical trials, the focus is now becoming how to transition these early phase manufacturing processes to a scale and quality suitable for late stage/commercial production.  This transition brings with it the question of how much the process has changed during scale-up and its impact on product comparability.  This session focuses on process scale-up and characterization including the use of novel types of (disposable) bioreactors, in-line process monitoring, and downstream strategies for cell purification and characterization.

Technical Session 2:  Novel technologies for cell therapy manufacturing

Session co-chairs:  Jamie Piret (University of British Columbia) and Jon Rowley (RoosterBio)

Invited speakers:  Jamie Piret (University of British Columbia) and Eytan Abraham (Lonza)

Description:  We are in a crucial period for the development of innovative cell therapy manufacturing technologies.  With the first major wave of potential products progressing through clinical trials, many organizations are confronting the challenges of economically ensuring the manufacture of safe and efficacious products.  Manufacturing technologies adopted today will be difficult to displace in the future due to regulatory and other constraints.  Thus, there is a unique window of opportunity for innovations to address the specialized needs of therapeutic cell manufacturing that are not already provided by other fields.  This session will address novel approaches to manufacture living cells ranging from technologies for small scale closed systems, scale-up bioreactor expansion and cell-friendly downstream processing, to improved methods for demonstrating the quality and safety of complex populations of cells.  These challenges must be aggressively addressed since cellular therapies should literally benefit millions of people in need.

Technical Session 3:  Product characterization and potency

Session co-chairs:  Anne Plant (NIST) and Chris Wiwi (Celgene)

Invited speakers:  Sadik Kassim (Novartis) and David Stroncek (NIH)

Description:  The commercialization of cell-based products presents unique challenges.  An evolving regulatory landscape, rapid advances in manufacturing technologies, complex mechanisms of action (MOA), and inherent variability in cellular material are just a few examples of these challenges. When considering process changes, cellular therapy manufacturers seek to apply sound engineering principles, develop good process understanding and use meaningful analytical methods for product characterization.  The diversity and complex nature of cell therapy products requires an increasingly broad set of analytical tools to assist in this endeavor.  Scientists engaged in assay development are challenged to select the most appropriate methods and adapt these assays to a quality environment.  Cell line and patient variability, poorly defined MOA, lack of reference materials and complex analytical methods/instruments underlie some of the technical difficulties facing the analytical team.  This session will discuss the testing strategies used by cell therapy manufacturers throughout the product development lifecycle, as well as solutions to commercial challenges such as potency assay development, comparability testing, measurement assurance and the automation of analytical methods.

Technical Session 4:  Manufacturing CAR T cells and other cancer immunotherapies: Challenges and progress

Session co-chairs: David Stroncek (NIH) and Marianna Sabatino (Kite Pharma)

Invited speakers:  Marianna Sabatino (Kite Pharma)

Description:  Adoptive T cell therapies have been used for many years to treat cancer, but complex manufacturing requirements and modest clinical benefits have limited the use of these therapies to early phase clinical trials.  T cells genetically engineered to express Chimeric Antigen Receptors (CAR), particularly CD19-CAR T cells, have shown great clinical promise. Since procedures to manufacture CD19-CAR T cells are relatively simple and low cell doses are required, efforts are underway to commercialize these products.  There are, however, some problems associated with manufacturing and analysis of CAR T cells.  Most CAR T cell manufacturing processes were adopted from those used in facilities at academic health centers, which are inefficient, expensive and make little use of automation.  The use of autologous T cells as starting material for CAR T cell manufacturing also presents some challenges with scale-out.  This session will discuss current methods used to manufacture CAR T cells and other T cell cancer immunotherapies and their limitations.  Methods to improve the production and analysis of these cells using automation, closed systems, and other innovations, as well as reducing the cost of manufacturing, will be discussed.

Technical Session 5:  Gene editing, vector production, synthetic biology, and genetic modification of cells

Session Co-chairs:  Paula Alves (IBET) and Robert Kutner (bluebird bio)

Invited speakers:  Fulvio Mavilio (Genethon), Xin Swanson (Lonza), and Ben Kleinstiver (Joung lab, Harvard)

Description:  The rapidly evolving fields of cell-based and in vivo gene therapy enable delivery of therapeutic genes or edits to defective genes.  There is a rich variety of delivery vehicles supporting a wide range of specific needs for genetic modification.  As a result, there is a wide variety of possible manufacturing processes and development challenges.  This session will address the major trends impacting bioprocess development including implementation of characterization methodologies to better understand and improve existing and novel expression technologies, the implementation of disposable and affordable manufacturing processes and technologies, and scale-up.  This session will also cover evolving process and expression technologies – and the applications of synthetic biology, data mining, and process modeling strategies – to provide the audience with an updated, contemporary understanding of the trends and challenges in gene and cell therapy.

Technical Session 6:  Collaborating with regulatory agencies to define the landscape for emerging cell-based therapies – challenges and lessons learned

Session Co-chairs:  Bernadette Keane (Keane Consulting) and Mohammad Heidaran (FDA)

Invited speakers:  Michael Paglia (bluebird bio) and Mohammad Heidaran (FDA)

Description:  The complexity and novelty of cell-based therapies compared to traditional biotherapeutics demand carefully crafted regulatory approaches to deliver effective treatments to patients without jeopardizing their safety.  Such approaches must be based on solid scientific data and rationale that is being developed in the industrial, academic, and government sectors.  As the field of cell therapies matures towards ubiquitous commercial realities, regulators across the world have been collaborating with scientific leaders, as well as sponsors of candidate cell therapies, to allow progress while addressing patient needs.  This session will focus on manufacturing-related regulatory challenges and approaches such as the demonstration of product comparability throughout manufacturing changes from early stage clinical development beyond proof-of-concept through to late stage pivotal trials intended to support commercialization.  Additional examples of challenges include sourcing of raw materials, control of cell processing at clinical sites, and development of suitable analytical methods.

Technical Session 7:  Bioprocess modeling – the road to informed decision-making for successful commercialization

Session Co-chairs: Dolores Baksh (GE Healthcare) and Suzanne S. Farid (University College London)

Invited speakers:  Robert Perry (Athersys) and Peter Zandstra (University of Toronto)

Description:  Successful development and sustainable commercialization models are top of mind for cell and gene therapy companies.  There is an emerging reliance on model-based approaches to provide enhanced process understanding and predictive insight that helps cell manufacturers more efficiently improve processes and optimize the properties of manufactured cells.  Bioprocess modeling challenges include consideration of needle-to-needle logistics, as well as accounting for all factors that could impact the properties and performance of cell products, including the inherent stochastic variability of manufacturing processes, cell functionality and cell therapy patients.  This session will discuss the role of bioprocess modeling, simulation, optimization and information management tools.  Contributions that present industrially-relevant case studies are especially encouraged.  This can include bioprocess economics models for achieving optimal cost of goods (COGs) at the commercial scale, simulation models to enhance facility design and capacity management across global sites, unit operation models to more accurately predict ideal operating conditions, chemometric models for root cause and data analysis, as well as assessment of the financial impact of process choices on the product development lifecycle.

Technical Session 8:  From method to manufacturing, ramping-up for commercial production

Session Co-chairs:  Nick Timmins (CCRM) and Greg Russotti (Celgene)

Invited speakers:  Nick Timmins (CCRM)

Description:  In the lifecycle of cell therapy commercialization, step-changes in thinking and approach occur throughout development as a product progresses from pre-clinical to clinical, and through the clinical trial pipeline.  But perhaps the biggest step of all is that from investigational product to on-market.  Compliance, logistics, scale, focus on cost of goods (COGs), and supply chain considerations, among others, increase substantially in magnitude.  Failure or underperformance in any one of these areas is potentially a fatal blow to success.  In this session, regulators and industry leaders who have walked-the-walk and can talk-the-talk of taking a product from development to commercial operations will share their strategies and vision for a successful commercial process.  As success is best built upon a solid foundation, this session will also explore how the approach used for the preceding development can smooth the transition to commercial manufacturing.

Poster Session:  Covers all conference topics

Session co-chairs:  Corinne Hoesli (McGill University)

Plenary Speaker

Kristi Anseth (University of Colorado)

Title:  Design of novel materials to regulate stem and progenitor cell expansion and differentiation

Abstract:  Cues from a cell’s microenvironment play a critical role in directing and maintaining cell fate in vivo.  Misregulation within the extracellular space can cause cell death or other aberrant behaviors associated with developmental defects and diseases such as fibrosis and cancer.  Thus, as one thinks about culturing stem cells or progenitor cells for functional studies or their delivery into patients for therapeutic purposes, it is prudent to consider the surrounding microenvironment, especially conditions that stimulate desired biological functions and/or integration with native tissue.  In this regard, multicomponent biomaterials and their physicochemical manipulation can serve as in vitro platforms to decipher some of the complexities of dynamic cell-matrix signaling.  This talk will focus on some of our recent efforts towards in situ hydrogel property manipulation with light, allowing intimate control of a cell’s microenvironment in both time and space.

Special Journal Issue

The Biochemical Engineering Journal (BEJ) is partnering with ECI Scale-Up and Manufacturing of Cell-Based Therapies V to publish a peer-reviewed special issue devoted to papers from oral and poster presentations at the conference. The conference chairs will prepare a guest editorial with a review of conference highlights to lead off the special issue and stimulate interest in the papers. As part of this partnership, the BEJ will provide open access for 3 months to papers in the assembled special issue. While the special issue is being assembled, papers will be published online 2-3 weeks after acceptance.

The special issue will be co-edited by conference chairs Bill Miller (BEJ Editor) and Tom Brieva. We encourage you to submit your best work to the special issue as an original paper, review, perspective, or short communication, depending on the nature of the presentation (see guide for authors at www.elsevier.com/locate/bej for more details). Details on manuscript submission will be made available closer to the conference.

Please see the special issue from ECI Scale-Up and Manufacturing of Cell-Based Therapies IV http://www.sciencedirect.com/science/journal/1369703X/108.

Conference Organization

Chairs:
Tom Brieva, Celgene Cellular Therapeutics
William Miller, Northwestern University
Chris Mason, University College London

Organizing Committee:
Eytan Abraham, Lonza
Paula Alves, IBET
Dolores Baksh, GE Healthcare
Ravi Bhatia, Janssen
Kim Bure, Sartorius
Joaquim Cabral, University of Lisbon
Jeff Chalmers, Ohio State University
Allen Chen, Bioprocessing Technology Institute
Ron Fedechko, Pfizer
Peter Fuhrken, Cellular Dynamics International
Brian Hampson, Progenitor Cell Therapy
Ohad Karnieli, Kernieli Ltd.
Todd McDevitt, Gladstone Institute
Alvin Nienow, University of Loughborough
So Ra Park, Inha University College of Medicine
Madhusudan Peshwa, Maxcyte
Jamie Piret, University of British Columbia
Anne Plant, NIST
Mark Powers, Thermo Fisher Scientific
Chris Ramsborg, Juno Therapeutics
Nick Timmins, CCRM
Ivan Wall, University College London
Jean Xu, Janssen

Steering Committee:
Barry Buckland, BiologicB
Manuel Carrondo, IBET
Peter Gray, The University of Queensland
Bob Nerem, Georgia Institute of Technology
Lars Nielsen, University of Queensland
Greg Russotti, Celgene Cellular Therapeutics
Peter Zandstra, University of Toronto

Sponsorship Opportunities

To view the Sponsorship Opportunities for this conference, click HERE.

ECI has revamped the sponsor packages to increase exposure.  New opportunities include an industrial promotion session and a brewery tour.

Conference Sponsors

Please click on the logo to visit the site.

Abstract Submission

Deadline for abstracts for oral presentations:              August 31, 2016
Deadline for abstracts for poster presentations:          August 31, 2016

One-page abstracts should be submitted as soon as possible and no later than the deadlines noted above.  The abstract should include both the significance of the research as well as results that will be discussed in order to allow a scientific assessment of the work by the organizers.

You will be asked to indicate:

  • If your abstract is for an oral and/or poster presentation
  • The session(s) for which it is being submitted
  • If you are a graduate student
  • Your possible interest in submitting a paper for the special issue of the BEJ devoted to this conference

All abstracts should be submitted electronically and submissions must follow the template provided at this link.

Conference Venue

San Diego, California’s second largest city, is known worldwide for its spectacular climate, 70 miles of pristine beaches, and attractions such as the San Diego Zoo, Sea World, San Diego Wild Animal Park, and Legoland.  Other highlights include sightseeing in the historic Gaslamp Quarter, Coronado, Little Italy or Balboa Park, the largest urban cultural park in the United States.  In the historic Gaslamp Quarter, consisting of 16½-blocks around Fourth and Fifth Avenues, grand Victorian-era buildings are home to more than 100 of the city’s finest restaurants, 35 pubs and nightclubs and 100 retails shops, as well as theaters, art galleries, offices and residential/work lofts. When the sun sets, this downtown neighborhood attracts thousands of diners, shoppers, theatergoers, and nightclub patrons.

The Hyatt Regency Mission Bay Hotel is located on beautiful Mission Bay.  The property, renovated in 2010, consists of three separate buildings that flank three outdoor pools.  Each of the 429 guestrooms offers the Hyatt “Grand Bed” with clock radios that feature an iPod docking system, a large work desk, flat screen TV and balconies with views of the Pacific Ocean, Mission Bay, or the hotel gardens.  The resort features a large swimming pool with poolside bar, a fine-dining restaurant, a spa, a marina with sport fishing and boat rentals, and has a new waterfront 24-hour Stayfit Gym. It is a quarter mile from SeaWorld and Mission Beach, and three miles from Old Town San Diego. The hotel offers bicycle rentals and features jogging and cycling paths.  There is a complimentary shuttle to Mission Beach.  Either self or valet parking is available with a surcharge.

The hotel is located at 1441 Quivira Avenue in San Diego.

For more information on the area, please visit these web sites:

San Diego Convention and Visitors Bureau: www.sandiego.org
Gaslamp Quarter: www.gaslamp.org
Hyatt Regency Mission Bay Hotel: http://missionbay.hyatt.com/hyatt/hotels-missionbay/index.jsp

General Information

Engineering Conferences International (ECI) is a 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 weeklong research conference provides morning and late afternoon or evening sessions in which major presentations are made. 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 that 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.

Engineering Conferences International
32 Broadway, Suite 314, New York, NY 10004
T: 1-212-514-6760 F: 1-212-514-6030 E: info@engconfintl.org

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