Scale-up and Manufacture of Cell-Based Therapies IV

General Announcement and Call for Abstracts

An ECI Conference Series

January 18-22, 2015
Hyatt Regency Mission Bay Hotel
San Diego, CA USA

ECI Pre-Conference Workshop:  Translating Cell Therapies from Lab Bench to Clinic

Call for Nominations:  Cell Therapy Scale-Up and Manufacturing Award

Register Now!

California_skyline_SanDiego

About This Conference

The fourth annual conference on Scale-Up and Manufacturing of Cell-Based Therapies is scheduled for January 18-22, 2015 and will take place at the Hyatt Regency  in San Diego.

This conference will focus on process development, scale-up, and manufacturing of cell-based therapies and will bring academicians, clinicians, industry leaders, and regulators from all over the world together to discuss the most critical scientific and engineering challenges in this field.  It is our aim that this conference will continue to play a central role in defining and refining the engineering sciences of cell-based therapies.

Conference Organization

Program Co-Chairs:

Greg Russotti, Ph.D., Celgene Cellular Therapeutics, USA
Chris Mason, Ph.D, MBBS, University College London, UK
Peter Zandstra, Ph.D, The University of Toronto, Canada
Thomas Brieva, Ph.D., Celgene Cellular Therapeutics, USA

Steering Committee:

Barry Buckland, BiologicsB
Lars Nielsen, University of Queensland
Greg Russotti, Celgene

Preliminary Program Agenda

Scale-Up and Manufacturing of Cell-Based Therapies IV

There is much clinical promise from emerging therapies based on administration of cells to patients as therapies for a diverse assortment of diseases.  The ability to manufacture and test cell products will be a critical factor in the anticipated success of cell therapies.  In particular, it is necessary to develop manufacturing processes that are cost-effective, scalable to produce sufficient supply, and reliable.  Testing methods that confirm product quality and provide feedback during process development and validation are also important.  However, the complexity of cellular products also increases the complexity of their manufacturing and testing.  This conference focuses on innovative approaches to develop, refine, scale-up, and commercialize processes to manufacture cell therapies.

PLENARY LECTURES

Stephen Ward (Cell Therapy Catapult)

Maish Yarmush (Rutgers University)

Fred Miesowicz (Argos Therapeutics)

Anne Plant (National Institute of Standards and Technology)

SESSION INFORMATION

  • Process development, process characterization, and process integration

Session chairs: Bob Deans (Athersys) and Jeff Chalmers (Ohio State University)

The development of a manufacturing process requires initial design, characterization that leads to process understanding, refinement based on understanding and experience running the process, integration of individual process components, and validation to demonstrate reproducible performance.  However, cell therapies present unique challenges in process development, process characterization, and process integration.  In this session, we present current approaches, specific challenges that bioprocess developers have encountered, and opportunities for development of bioprocesses for cell therapy.  Examples of these challenges include designing a process to fit the target business model, using process characterization data to define parameter set-points and limits, and assembling unit operations into an integrated manufacturing process.

Invited speakers: Matt Croughan (KGI) and TBD (Athersys)

  • Scale-out, scale-up

Session chairs: Yan Li (Florida State University) and  Ben Fryer (Johnson  & Johnson)

Producing sufficient quantities of cells for in vivo testing and commercial scale production of a cell therapy is a challenging task.  “Scale-out” (increasing the number of times a small-scale process is performed) and “scale-up” (increasing the size of each process performed) are the two main approaches to generate the magnitude of cells required for commercial production.  Most cell therapies currently in clinical development use a scale-out manufacturing system, especially for autologous therapies, where scale-out is the only option.  Consequently, modifications and improvements to scale-out processes are required to meet current cell therapy demands.  Meanwhile, the projected demand for allogeneic therapies is expected to surpass the capacity of scale-out processes.  As a result, scale-up systems (e.g., stirred tank/suspension bioreactors or continuous centrifuges) are being applied to cell therapies to meet large cell demands.  This session highlights recent advances in both scale-out and scale-up approaches to address the needs of pre-clinical, clinical, and commercial applications.

Invited speakers: Donald Powers (Janssen) and Larry Couture (City of Hope)

  • Product characterization, process monitoring, and potency

Session chairs: Steven Bauer (FDA), Jeanne Loring (The Scripps Research Institute) and Stephen Minger (GE)

Due to the novelty and complexity of many proposed cell-based products, a significant challenge for the field of cell therapy is to identify product characteristics that reliably predict their effectiveness and safety.  Identification of such predictive characteristics (aka quality attributes), tremendously enhances the ability to optimize manufacturing through implementation of meaningful in-process testing.  Further, quality attributes also allow development of lot-release criteria that assure product quality and meet the goals of both safety and effectiveness.  In particular, such predictive characteristics could form the basis for potency assays, one of the more challenging aspects of cell-based product characterization.   This session focuses on various approaches toward development of predictive characteristics that are useful for cell-based product characterization.

Invited speakers: TBA

  • Vector production and scale-up for cell therapy applications

Session chairs: Otto Wilhelm Merten (Genethon) and J. Fraser Wright (CHOP)

The ability to effectively transfer genetic information into human cells for the purposes of gene transfer, gene repair, or the ex-vivo modification of therapeutic cells enables novel approaches in the field of gene therapy, tissue repair, and cell therapies. Virus-derived vectors for gene transfer can be distinguished into those that integrate into the target genome, such as retroviral and lentiviral (LV) vectors, and those that are primarily non-integrating, such as adeno-associated virus, adenoviral, or non-integrating LV vectors.  The choice of vector is based on the therapeutic objective and risk/benefit profile.  For example, the long-term persistence of gene transfer of integrating vectors is a good fit for stem cell products in spite of a slightly elevated, albeit small, risk of random insertional mutagenesis.  However, integrating vectors may be replaced for some applications by emerging genome editing technologies such as CRISPR/Cas9 that allow the safe and efficient targeted insertion of a nucleotide sequence into the cellular genome.  All virus-derived vectors present production and scale-up challenges, such as the development of stable cell lines, suspension culture, and purification.  This session highlights recent advances in production and scale-up of vectors relevant to cell therapies as well as emerging genome editing approaches.

Invited Speakers: Thomas Gaj (UC Berkeley) and John Gray (Audentes)

  • Automation and next generation biomanufacturing methods

Session chairs:  Kim Bure (Sartorius) and Chris Hewitt (Loughborough University)

Many types of complex processes are used to manufacture cell therapies.  These complex processes are exacerbated for patient-specific products by the repetition of the process for each patient.  Thus, cell therapy manufacturing is challenged by operator variability, large labor needs, risk of operator error, and difficulty of scale-up.  There are numerous candidate solutions to these challenges.  Automation promises the reduction of operator variability and error as well as operator-to-operator variability.  However, development of automation requires careful design, investment, and equipment validation.  Accordingly, a strategic plan for product development must include these considerations for automation timing and approach.  Other examples of solutions to cell therapy manufacturing challenges include novel fixed bed, hollow fiber, or microcarrier-based bioreactors.  This session addresses automation and next generation biomanufacturing methods.

Invited speakers: Regine Eibl (University of Zurich)

  • Downstream: From purification to the patient

Session chairs: Karen Coopman (Loughborough University) and Kim Warren (Lonza)

There are numerous operations that must be performed after cell populations are established and expanded.  The first is the removal of cells from their source, typically a culture.  This process is more challenging for adherent cell types.  Cells are then typically washed to change buffers and deplete upstream process components or debris.  Once cells are formulated, cells are stored for some time and delivered, either in a cryogenic state or in a semi-stable fresh state.  Delivery requires maintenance of the conditions that allow cell stability and appropriate logistical planning, including compliance with security and transportation regulations.  Finally, preparations at the site of administration prior to patient dosing vary with product design.  This session covers the design and process development unique to each of these downstream activities.

Invited speakers:  Andrew Picken (Loughborough University) and Mark Petrich (Merck)

  • Physical and biochemical regulation of cells in bioprocesses

Session chairs: Dave Schaffer (UC Berkeley) and Wen Bo Wang (CDI)

Numerous physical and biochemical cues work in concert to regulate cell growth, phenotype, and function.  A more complete understanding of these parameters enables a rational approach to the engineering of manufacturing processes for cell-based therapies such as fully defined systems for scalable culture, control of stem cell behavior, and graft survival and functional integration. This session covers recent advances in the following areas: mechanisms of regulation by extracellular cues and methods for incorporation of basic knowledge into bioprocesses, integration of engineered materials into bioprocesses, scale-up of bioprocesses by application of advances in cell biology, and impact of physical and biochemical parameters on cell fate.

Invited speakers: Peter Zandstra (University of Toronto) and Peter Fuhrken (CDI)

Abstract Submission

One-page abstracts that include specific results and conclusions to allow a scientific assessment of a proposed oral presentation or poster are invited.

Oral abstract deadline:            October 10, 2014
Poster abstract deadline:         October 15, 2014

Abstracts should be submitted electronically at https://ssl.linklings.net/conferences/cellbasedtherapies/

Please indicate the session(s) for which you would like your abstract considered.

Major Sponsors

Sponsorship Opportunities

Click on this link to view Sponsorship Levels

Conference Venue

 Hyatt Regency Mission Bay Hotel in San Diego, California

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

Travel Information

Transportation from the airport – Details are available here:
www.supershuttle.com/default.aspx?content=SanDiego

Entry visas for USA
If you require a visa to enter the USA, please visit the website of The National Academies for the most current, detailed information regarding traveling to the United States.
http://www.nationalacademies.org/visas/Traveling_to_US.html

If you require a special letter of invitation from ECI, please send an e-mail to info@engconfintl.org and we will send you an information form to complete.

Discount
Delta Airlines offers a Delta Meeting Network discount for conference participants traveling to the Cell-Based Therapies IV Conference. The amount of the discount depends on the fare code.

To obtain the discount, please follow the steps below for the online Delta booking tool:
1- Visit http://www.delta.com
2- Choose your flights
3- Under “Meeting Event Code,” enter NMJZH

Fees and Registration

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, Tuesday and Wednesday nights) and meals (excluding dinner on Tuesday), taxes, and gratuities from the reception on Sunday through breakfast on Thursday. Incidental fees (telephone calls, faxes, laundry, etc.) are billed to your personal account by the hotel.

ALL PARTICIPANTS (INCLUDING MEMBERS OF THE ORGANIZING COMMITTEE AND INVITED SPEAKERS) ARE REQUIRED TO REGISTER.

The conference fees are:

Register on or before December 19, 2014

Register after December 19, 2014

Participant (single occupancy or sharing room with a guest; guest fee additional)

US $2,400.00

US $2,600.00

Participant (sharing a room with another participant)

US $2,030.00

US $2,230.00

Bona fide Graduate Student (sharing a room with another student) (Those in this category must send proof of current status – copy of current Student ID can be faxed to 1-212-514-6030 or emailed to Kathy@engconfintl.org)

US $1,615.00

US $1,815.00

**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (All conference-included meals and receptions, including the banquet)

US $810.00

US $810.00

Local residents who do not require accommodations may contact ECI (info@engconfintl.org) for pricing with the cost of lodging excluded.

If you plan to bring children to the conference, please contact ECI (info@engconfintl.org) for pricing.

Pre-Conference Workshop Fees

The workshop will be held on Sunday, January 18, from 9:00am – 5:00pm. The workshop fees include workshop materials, coffee break and lunch.

The Pre-Conference Workshop fees are:

Register on or before December 19, 2014

Register after December 19, 2014

Pre-Conference Workshop for Participant (participant must be registered for the conference to receive this rate)

US $200.00

US $300.00

Pre-Conference Workshop for Student Participant

US $150.00

US $250.00

Workshop Only (will not be attending the conference)

US $300.00

US $400.00

The Pre-Conference Workshop fees are non-refundable, but may be transferred to another participant.

Conference Registration

You will need a login name and password to register for ECI conferences through our online system. If you have been a recent participant at an ECI conference or have submitted an online application or request for information about an ECI Conference, you may already have an account with us. If you know your login information please use it. If you are not sure whether you already have a login and password, please click on automated password retrieval and enter your e-mail address before creating a new account. If we don’t have a valid email address on file for you, a pop up window will appear stating that no records were found. Click “OK” and then follow the instructions to create a new account. If you have any questions or experience any difficulties, please email tressa@engconfintl.org.

Special Notes and Payment Instructions

We suggest that you register as soon as possible to be certain that you will have a hotel room at the conference rate.  Late registrations will be accepted on a space available basis.

All participants are encouraged to register before December 19, 2014There is a discounted price for registering before this date and hotel space cannot be guaranteed for registrations received after this date.  Your registration is not officially confirmed until we receive payment of the amount due and ECI reserves the right to cancel your room registration if payment is not received. Your invoice/receipt will automatically be e-mailed upon of receipt of your registration.

Because of contractual guarantees made with the hotel for room and meal functions, no shows, late arrivals, missed meals and early departures cannot receive fee adjustments.

Payment must be made by credit card (Visa, Mastercard, Amex), check or money order drawn on a U.S. bank in U.S. dollars, payable to ENGINEERING CONFERENCES INTERNATIONAL. Checks or money orders in any other currencies are NOT ACCEPTABLE.  Payment is made on the web site except for those who are sending payment by wire transfer or have a purchase order from their company/institution.

WIRE TRANSFER PAYMENT: If you are planning to make payment by wire transfer, please contact ECI for the bank information. You must add $30 to cover ECI bank charges. Please reference your full name and the conference title.  Fax a copy of your bank transfer papers to ECI (Fax: +1-212-514-6030) or email a scanned copy to kathy@engconfintl.org.  This is very important – otherwise it is extremely difficult to trace your payment and you may not receive a receipt prior to the conference.

Cancellation Policy: Cancellation must be received by ECI in writing at least three weeks prior to the start of the conference in order for a full refund to be considered. The ECI auditors require that refunds for all conference cancellations be processed after the conference so that the necessary back-up information (i.e., hotel list of those in-house) can be attached to the refund request and ECI can verify that the hotel has not charged a cancellation fee. Cancellations received less than three weeks prior to the conference start date are subject to a $200 cancellation fee plus any direct expenses incurred by ECI.

If you have a disability and may require accommodation in order to participate fully in this conference, please indicate this when you register. An ECI representative will contact you to discuss your specific needs. If you have special dietary requirements (e.g., vegetarian or a food allergy), please make a note on your registration card.  The chef needs to know this information in advance if we are to accommodate you.

Should you have specific questions regarding your registration, please contact Kathy Chan (Kathy@engconfintl.org).

Preliminary Program

See above “Preliminary Program Agenda.”

Please forward this link to colleagues who may be interested in the conference topic.

Register Now!

To register, click on this LINK.

General Information

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 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 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.

The Engineering Conferences International conferences calendar and other information can be found on the ECI web site: www.engconfintl.org

Engineering Conferences International
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T: 1-7212-514-6760 – F: 1-212-514-6030

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