Cell Culture Engineering XIV

An ECI Conference Series

May 4-9, 2014
Fairmont Le Château Frontenac
Quebec City, Canada

2014 Cell Culture Engineering Award Winner: Jeffrey Chalmers

2014 Martin Sinacore Outstanding Young Investigator Award Winners: Colin Clarke and Corinne Hoesli

Final Program                              Workshops                         Poster Presentations

Poster presenters: The display area available for each
poster presentation is 4 ft high by 4 ft wide

Visa Information–Important                                                                Register Now!

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About This Conference

Since 1988, the Cell Culture Engineering conferences have been held bi-annually and have developed into the leading global venue for the academic, industrial and regulatory communities for intensive interactions and debates to create solutions for improving human health and life by enabling rapid development and high quality manufacturing of an ever increasing number of viral vaccines, recombinant proteins and monoclonal antibodies. The 2014 conference will be the 14th conference in this highly successful series and will be held at one of the most beautiful urban resort hotels, the Fairmont Le Château Frontenac, nestled in the heart of Old Quebec City. (http://www.fairmont.com/frontenac-quebec/)

This Cell Culture Engineering XIV conference will bring together about 300 selected participants of top academic, industrial and governmental researchers from all over the world. We will celebrate the tradition of high quality and relevant accomplishments and debate future solutions in the area of animal cell culture science and engineering. Consistent with this excellent tradition, the scientific program will focus on topics ranging from the frontiers of fundamental biologic science around animal cells, the engineering challenges of cell culture process development and implementation, the latest regulatory concepts such as QbD and design space for improving process design and product quality, strategies for accelerating development of high quality and cost effective biosimilars, and opportunities for international collaborations.

The program will consist of invited and solicited oral presentations and poster presentations.

Conference Organization

Conference Chairs:

Weichang Zhou, Ph.D., Vice President, Biologics Process Development, Wuxi App Tec Co., Ltd, China, weichang_zhou@wuxiapptec.com

Prof. Amine Kamen, Professor, Department of Bioengineering, McGill University, Montreal, QC, Canada; amine.kamen@mcgill.ca and National Research Council, Canada, amine.kamen@cnrc-nrc.gc.ca

Steering Committee Members

  • Dana Andersen (Genentech, USA)
  • John Aunins (Janis Biologics, USA)
  • Mike Betenbaugh (Johns Hopkins University, USA)
  • Barry Buckland (BiologicB LLC., USA)
  • Jeff Chalmers (Ohio State University, USA)
  • Matt Croughan (Keck Graduate Institute, USA)
  • Peter Gray (University of Queensland, Australia)
  • Carole Heath (Amgen, USA)
  • Wei-Shou Hu (University of Minnesota, USA)
  • Amine Kamen (NRC, Canada)
  • Konstantin Konstantinov (Genzyme, USA)
  • Lynne Krummen (Genentech, USA)
  • Kelvin Lee (University of Delaware, USA)
  • Mark Leonard (Pfizer, USA)
  • William Miller (Northwestern University, USA)
  • Jamie Piret (University of British Columbia, Canada)
  • Octavio Ramirez (UNAM, Mexico)
  • Weichang Zhou (Wuxi App Tec Co., Ltd, China)

CCEXIV Organization Committee members

  • Hal S. Alper, University Texas,  Austin
  • Kevin Bailey, Regeneron Pharmaceuticals, Inc., USA
  • Michael Butler, University of Manitoba, Canada
  • Chris Chen, WuXiAppTec, China
  • Rohini Deshpande, Amgen, Inc., USA
  • Alain Garnier, Laval University, Quebec, Canada
  • Francesco Godia, UAB, Barcelona, Spain
  • Anurag Khetan, Boehringer Ingelheim, Germany
  • Bob Kiss, Genentech, Inc., USA
  • Gyun Min Lee, KAIST, South Korea
  • Gargi Maheshwari, Merck, USA
  • Jim Michaels, BioMarin, USA
  • Takeshi Omasa,  Osaka University, Japan
  • Terry Papoutsakis,  University of Delaware, USA
  • Thomas Ryll, Biogen Idec, USA
  • Wen-Song Tan, East China University of Science and Technology, Shanghai, China
  • Tongtong Wang, Eli Lilly & Company, USA
  • Yuan Xu, Novartis, USA
  • Peter Zandstra, University of Toronto, Canada
  • Chun Zhang, Shire, USA

Oral Sessions Description

Session I: Novel protein biologics development

Chairs: Kenneth Karey, Genzyme, USA and Mike Butler, University of Manitoba, Canada

This session will cover the development of novel recombinant proteins.    This will include novel antibodies such as those with bispecific functionality or IgM isotypes, enzymes, or application to new targets that might include infectious diseases.  The session will explore the technologies that are available now and in the future to address the high demands for specific recombinant proteins but with consistent quality.   There may also be modifications to existing proteins that might widen their targets of application, improve their efficacy, or increase their manufacturability as biopharmaceuticals.

Session II: Cell line engineering and accelerating development: Vector design, novel approaches for cell engineering, solutions to difficult to express proteins

Chairs: Rohini Deshpande, Amgen, Inc., USA  and Yves Durocher, NRC, Canada

Production processes for biologics strive to deliver speed, high quality and cost-effectiveness.  Investment in optimizing development timelines, achieving high yield and desired product quality, is imperative to obtaining favorable cost of goods and increasing access of biologics to meet patient needs. Generating a stable production cell line with high yield and desired product quality is an important first step to meet this goal.  Over the years, several technological improvements have been achieved in the generation of production cell lines but the processes still remain time consuming and empirical.  Although derived from the same host cell, vastly different clones are often generated by the time transfection, selection/amplification, clonal isolation, and expansion steps are completed.  Extensive rounds of screening processes are often required to identify the best cell line that meets the productivity and product quality criteria. We invite presentations from academia and industry in this session to shed light on understanding potential limitations and debottlenecking this process with focus on improving specific/volumetric productivity and timelines; development of improved vectors, novel selection strategies, engineering of host cell lines, and protein engineering.  We also invite presentations on rapid process platforms and new development strategies, particularly with respect to difficult to express proteins.

Session IIIProcess development, scale-up and implementation for commercial manufacturing

Chairs: Kevin Bailey, Regeneron; Gyun Min Lee, KAIST; Bob Kiss, Genentech

The biotech industry has seen many successes in commercial cell culture process development and manufacturing implementation, in part due to the contributions of cell culture engineers.  That said, the path to success in large-scale processing is not always smooth.  This session will focus on sharing lessons learned from significant cell culture issues encountered during late stage development, scale-up for commercial implementation, or in “routine” commercial manufacturing.  We encourage submission of case studies or other examples of these types of challenges, particularly as they relate to establishment of sufficient process knowledge in moving towards the goal of planned and predictable performance in commercial manufacturing.  Presentations may come from, but are not limited to, the following areas: Phase III process development and scale-up, commercial process qualification and transfer, facility startup, and change management as it relates to raw materials and implementation of process improvements. Submissions are encouraged from all sectors (industry, academia, regulatory).

Session IV:  Cell culture process intensification: higher titers and higher productivity
Chairs: Thomas Ryll, Biogen Idec, USA and Takeshi Omasa, Osaka University, Japan

Cell culture process productivity has made enormous gains over the last 15 years. For Mabs we now routinely achieve titers in the 5 g/L range. Much of this achievement was accomplished by intensifying the process formats through higher cell mass and improved culture longevity while maintaining high cellular productivities. This session will review further progress in this area with target to achieve even higher titers and volumetric productivities for recombinant products. The scope includes monoclonal antibodies as well as other more sensitive products that may require specific process adaptations for efficiency and process intensity. Areas of interest include such as: process strategies and equipment aspects for ultra-high cell mass and productivity, culture longevity, high volumetric output, high intensity process platforms, applications of process intensification to sensitive products, manufacturing implementation and challenges as well as specific downstream technologies that support highly intensive cell culture processes.

Session V: Process impacts on product quality

Chairs: Laura A. Palomares, UNAM, Mexico and Stacey M. Kaneshiro, Eli Lilly and Company, USA

Biopharmaceutical products from cell culture are characterized by their high complexity, and can often only be produced with the translational and posttranslational machinery available in animal cells.  Modulations to this posttranslational activity can then impact the pharmacology, biological activity, and safety (e.g. immunogenicity) of the product.  The cell culture environment may also be the source of other intracellular/extracellular chemical and enzymatic reactions that alter protein quality.  In this session, the impact of process on the characteristics of biopharmaceutical products will be discussed, with focus on the features that intentionally or indirectly determine product functionality.  Strategies to overcome process constraints such as media chemistry, raw material variability, or fixed processing conditions that affect product quality will be included.  Integrative approaches for process design, based on risk assessment, that robustly deliver the target product quality profile out of cell culture are especially welcome.

Session VI: Big-data ‘omics and new technology applications for driving better process development

Chairs: Hal S Alper, University of Texas Austin, USA and Timothy Charlebois, Pfizer, USA

The performance of mammalian cell culture based bioprocesses is heavily dependent on the interplay between the host cell, the molecule being expressed and the process conditions employed.   Recent technological advances have been able to precisely quantify the intracellular interactions and identify key components related to improved cell performance and process design.   This session will focus on recent progress in the development and utilization of cutting-edge tools that are ushering in a new era of cell culture development, in which cell phenotypes in terms of yield, product quality and consistency are scientifically accessible and processes are less constrained by risks of changes and less defined by empirical outcomes. This session will highlight how a combination of ‘omics, high-throughput process characterization and product analytical technologies are providing insights and opportunities to drive cell culture to new levels of performance and control.  Moreover, the goal of this session is to demonstrate that new technologies can speed the design cycle for cell line development.

Session VII: Cell therapy vs. protein biologics manufacturing: Problem solved or paradigm shift?
Chairs: Peter Zandstra, University of Toronto, Canada and Madhusudan V. Peshwa, MaxCyte, Inc., USA

Incredible progress had be made in the optimization and scale-up of protein production. We are now at an inflection point in the development of cell therapies and questions are being increasingly asked about strategies to manufacture cell therapy products at scale, at lower cost, and with increased control. In this session with will compare and contrast key aspects of cell therapy and protein biologics manufacturing, and discuss, with an expert panel, where lessons can the taken forward and where new strategies, technologies and policies need to be developed.

Session VIII:  Accelerating Development of Biosimilars

Chairs: Ana Maria Moro, Instituto Butantan, Brazil; Chris Chen, Wuxiapptec, China; and Yuan Xu, Novartis, Switzerland

The time has arrived for patent expiration for the first biologicals derived from recombinant technology. By 2017, ~$70 bn in originator sales are losing patent exclusivity, representing roughly 40% of the estimated large molecule therapeutics market. Naturally, biosimilars are becoming an increasingly important area of interest for the pharmaceutical industry globally. The high complexity of biosimilar products and the inability to demonstrate identity to a level typically possible for small molecules require specific scientific and regulatory approaches to ensure a high degree of similarity that is sufficient to reflect the safety and efficacy of the reference product. The regulatory landscape is evolving globally.  The guidelines, in general, outline a stepwise approach to demonstrate biosimilarity with advice on the analytical and clinical studies required of a biosimilar. Specifically, analytical structure and functional analyses provide the foundation of a biosimilar development program.  This session will include a mix of speakers from regulatory authorities, generic companies developing biosimilars, and innovator companies moving into the biosimilar space.  Methodologies used for demonstrating analytical similarity and challenges for providing adequate preclinical and clinical data to regulatory authorities to make a conclusion of similarity in a global environment will be discussed. Case studies of experiences gained with the first biosimilar products, e.g., in Europe and Canada, will be presented. The forum will provide opportunities for the scientific community, pharmaceutical industry and regulatory authorities to debate strategies for accelerating biosimilar development in both the emerging and Western markets.

Workshop Sessions

There will be 10 workshops.

The overall workshop co-chairs are Ellen Johnson, Amgen, Inc., USA; Alain Garnier, Universite Laval, Quebec, Canada; Marcella Yu, Genzyme Corporation, USA; and Georg Schmid, Roche, Switzerland

The potential topics are:

1. Opportunities for International Collaboration  Chairs:  Manuel   Carrondo, IBET, Portugal, mjtc@ibet.ptWen-Song Tan, East China University of Science and Technology, China, wstan@ecust.edu.cn
2. Scale-up and Scale-down Challenges 
Chairs:  Ashraf Amanullah, Gilead Sciences, USA, Ashraf.amanullah@gilead.com; Gregg   Nyberg, Amgen, USA, gnyberg@amgen.com
3. Single-use Technologies 
Chairs: Sadettin Ozturk, MassBiologics, USA, Sadettin.Ozturk@massbiologics.org; Jean-Marc Guillaume, Sanofi Pasteur, France, jean-Marc.Guillaume@sanofipasteur.com
4. Future Manufacturing Design 
Chairs:  Suzanne   Farid, University College London, United Kingdom, s.farid@ucl.ac.uk; Jason Walther, Genzyme, USA, jason.walther@genzyme.com
5. Applications of -omics Technology
Chairs: Lars Nielsen, University of Queensland, Australia, Lars.Nielsen@uq.edu.au; Terry   Papoutsakis, University of Delaware, USA, epaps@udel.edu
6. Reducing Time from Product Candidate to the Clinic
Chairs:  Tiffany Rau, Eli Lilly, USA, tiffanyrau@aol.com; Martin Allen, Pfizer, USA, martin.j.allen@pfizer.com
7. Novel Development of Cell Culture Media
Chairs: Marc Aucoin, University of Waterloo, Canada, maucoin@uwaterloo.ca; Yao-Ming Huang, Biogen Idec, USA, Yao-ming.Huang@biogenidec.com
8. Cell Culture Manufacturing Safety: Prevention of Contamination of Adventitious Agents
Chairs: Armin Opitz, Genzyme, USA,  Armin.Opitz@genzyme.com ; Harmit Vora, BioMarin, USA, hvora@bmrn.com
9. Product Comparability Assessment During Development and Post-Launch
Chairs:  Gino Grampp, Amgen, USA, ginog@amgen.com; Mark Moody, Merrimack, USA , mmoody@merrimackpharma.com
10. QbD & Design Space
Chairs: Brian Kelley, Genentech,USA, kelley.brian@gene.com; Tongtong Wang, Eli Lilly, USA, wangto@lilly.com 

Major Sponsors

 

 

 

 

Sponsor Opportunities

Click HERE for a list of opportunities for conference sponsorship.

Abstract Submission

Abstracts of approximately 300 words should be submitted as soon as possible and no later than the deadlines.  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.  Please indicate the session for which you are submitting your abstract, or else select “poster presentation.”

For session information, see Oral Session Descriptions.

Only a limited number of oral presentation slots are available and thus all submissions for oral sessions will be considered for both oral and poster presentation.

Call for Abstracts

Oral Abstract Deadline: Closed
Poster Abstract Deadline: Closed

Abstracts of all presentations will be published in the conference program, available to all participants at the time of the conference.

Conference Venue

Quebec City  Beautiful and historic Quebec City, the capital of the province of Quebec, and located along the banks of the Saint Lawrence River, is one of the oldest European settlements in North America.  It was founded by the French explorer Samuel de Champlain in 1608.  Prior to the arrival of the French, the area was the home of a small Iroquois village.  Another French explorer, Jacques Cartier, was the first European to ascend the St. Lawrence Gulf, claiming “le Canada” for France.  The word “Kebec” is an Algonquin word meaning “where the river narrows.”  Quebec City’s maritime position and the presence of cliffs overlooking the St. Lawrence River made it an important location for economic exchanges.  In 1620, Champlain built Fort Saint-Louis on the top of Cape Diamond, near the present location of the Chateau Frontenac in the Upper Town. As the only fortified city north of Mexico, Québec’s rich and diverse history has been impeccably preserved. Narrow winding streets, old stone homes, and ramparts with cannons contribute to the old-world charm that permeates every square inch of the city and provides a relaxing atmosphere to its visitors.

More information about Quebec City can be found at http://www.quebecregion.com/en

Useful information (e.g., shopping hours, speed limit, emergency numbers, etc.) can be found at
www.quebecregion.com/en/useful-information

A smart phone app called Discover Quebec is available.  https://itunes.apple.com/app/discover-quebex/id688290868?mt=8

The Fairmont Le Château Frontenac, generally recognized as the most photographed hotel in the world, was designated a National Historic Site of Canada in 1980.  The hotel is perched atop a tall cape overlooking the Saint Lawrence River and affords a spectacular view, in addition to distinctive elegance and world class hospitality.  The hotel stands above Old Quebec City, designated by UNESCO as a World Heritage Site..

Fairmont Le Château Frontenac
1, rue des Carrières
Québec, Québec
Canada G1R 4P5
Telephone: +1-418-692-3861 Fax: 1-418-692-1751
Email: chateaufrontenac@fairmont.com

The hotel was designed by American architect Bruce Price, as one of a series of “château” style hotels built for the Canadian Pacific Railway company during the late 19th and early 20th centuries.  The newer portions of the hotel—including the central tower—were designed by William Sutherland Maxwell.

The Château Frontenac was named after Louis de Buade, Count of Frontenac, who was governor of the colony of New France from 1672 to 1682 and 1689 to 1698. The Château was built near the historic Citadelle, the construction of which Frontenac had begun at the end of the 17th century. Frontenac’s coat-of-arms can be seen on the outside wall of the entry arch and many other areas within the hotel. History casts a long architectural line: a 300-year-old stone bearing the Cross of Malta emblem is among the interior stones of the hotel’s vaulted lobby.

The Quebec Conference of 1943, at which Winston Churchill, Franklin D. Roosevelt, and Mackenzie King discussed strategy for World War II, was held at the Château Frontenac.

All guest rooms at Fairmont Le Château Frontenac offer the following amenities:

  • Air-conditioning with individual climate control
  • Alarm clock-radio
  • Cable television with in-room pay movies and video games
  • Wireless & High Speed Internet Access (fees apply if you are not a member of the Fairmont President’s Club)
  • Coffee/Tea maker (Nespresso)
  • Hair dryer
  • Iron and ironing board
  • Mini-bar
  • Telephone equipped with voice-mail
  • Windows that open

The Fairmont President’s Club

We encourage all conference participants to become a member of the Fairmont President’s Club in order to take advantage of the following

  • Complimentary, in-room high-speed Internet access
  • Complimentary local calls and no service charge on toll-free calls
  • Complimentary health club access
  • Daily room delivery of local or national newspaper
  • Savings (10%) on Willow Stream Spa treatments and products
  • Savings (10%) at the Fairmont Store

To enroll (it is free): https://www.fairmont.com/fpc/enroll/

Travel Information

Transportation to Quebec City

By Air– Quebec City Jean Lesage International Airport (YQB)

http://www.aeroportdequebec.com/en/

The airport, located about ten miles from the city, offers convenient connecting flights to several large transportation hubs and direct flights from New York, Chicago, Philadelphia, Montreal and Toronto.

Depending on traffic, the airport is 30-45 minutes by taxi from the Fairmont La Chateau Frontenac.  The hotel does not offer a shuttle. In order to find a taxi, a limousine or other means of transportation, please go to the information desk inside the terminal before the security checkpoint of the airport.  The taxis charge a flat rate of CDN $35.00 (plus tip) to (or from) downtown Quebec City.

You can get a TAXI at one of the various taxi stands at the airport, at the bus station, at the train station or in the city.

By Train – Rail Canada – Gare du Palais (Central Station)
www.amtrak.com/adirondack-train

Visitors travelling by train from the United States will come to Montreal on Amtrak and then transfer to VIA Rail Canada to Quebec City.  The trip from New York City to Montreal is considered one of the ten most scenic train rides in the world. Trains leaving Penn Station (New York City) in the morning reach Montreal in the evening.  Phone: 1-800-USA-RAIL (1-800-872-7245)

By Bus – Greyhound

Visitors traveling by bus from the USA come to Montreal via Greyhound and then transfer to Orleans Express for Quebec City.  Orleans Express Coach Lines have daily service between Quebec City, Montreal and other destinations in the province of Quebec.  Phone: 1-800-661-8747 (Greyhound)

General Information
www.quebecregion.com/en/transportation

Fees and Registration

Conference Fees

The conference fee is all-inclusive. It includes registration, accommodations, meals (with the exception of dinner on Wednesday), conference banquet, taxes and gratuities from dinner on Sunday through breakfast on Friday. Nights included in the registration fee are: Sunday, Monday, Tuesday, Wednesday and Thursday. Conference participants will be responsible for incidental personal hotel costs, such as telephone calls, laundry, faxes, etc.

All participants, including members of the organizing and technical committees, are required to register.

Invitation only conference

This conference is by invitation only. Invitees will be sent an email with a link to the conference registration page.  To be considered for an invitation, please submit the online application.

Note: If you previously completed the online Request for the Next Mailing, you have already been added to the list of applicants.

The conference fees are:

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

US $3,095.00

Participant (sharing a room with another participant)

US $2,535.00

Bona   fide Graduate Student (sharing a room with another student in a   hotel room) (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 $2,020.00

**Fees for Guest/accompanying person sharing bedroom with single   occupancy participant. (All meals and breaks included.)

US $890.00

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

Should you wish to arrive early or stay after the conference, please download the appropriate Pre/Post reservation form (Click here) and make your reservations directly with the hotel.

Final Program

Click HERE to view the final program.

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

Register Now!

Click HERE to register for this conference.

ECI 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

 

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