Single-Use Technologies III: Scientific and Technological Advancements

An ECI Conference Series

September 23-26, 2018
Snowbird Resort
Snowbird, Utah

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Session Descriptions                 Call for Abstracts!

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

Obtaining a Visa to the United States

About This Conference

Single-Use Technologies III: Scientific and Technological Advancements is the third event of an ECI conference series started in 2015 and focusing on the scientific and engineering aspects of single-use technology.

The conference will be a 3-day event (Sept. 23 to 26, 2018) in Snowbird, UT, USA and will target 100-120 attendees. The conference will have speakers from industry and academia, single-use final product (e.g. bags, assemblies) manufacturers, film/resin manufacturers as well as keynote speakers from the biopharmaceutical industry, experts in polymers/materials science and manufacturers of novel biomedical devices.

The third series of this conference will build on the success of the first two editions and expand further to include scientific and technological developments in single-use upstream and downstream processing for a variety of biologics and will invite presentations looking at the challenge of integration and continuous processing approaches and how single-use technology can accelerate the quest for speed and flexibility in this space.  A new session on cell and gene therapy is organized to discuss the specific requirements of the industry for emerging applications of single-use systems.  It is clear that collaborative work and multidisciplinary discussions are needed to allow implementation of single-use technology to reach its full potential.  In order for better understanding and communication among various functional areas, half-day (Sept. 23, 2018) pre-conference workshops will share fundamental knowledge on polymers and cell and gene therapy bioprocessing.

Session Descriptions

Session 1: Polymers in New Biopharmaceutical Applications

This session will focus on new developments in polymer products that are used or intended to be used in biomanufacturing. These may include, but are not limited to, 3D printing, overmolded silicone, etc. Focus will be on how different single-use components are manufactured, what is involved and what are the important parameters and properties to ensure a good product.

Case studies are invited that address one or more of the following questions: Are there applications that current technology can’t meet, but could be met with a Single Use material with different properties? Can polymers and films be optimally designed for specific applications? Can lessons/challenges from other industries (e.g., Single-use pre-filled syringes, IV bags) be leveraged for bioprocessing? Case studies where a company applied lessons from one area or industry to another are encouraged.

Session 2: Interaction of Polymers with Bioprocess Fluids and Bioproducts (including Extractables and Leachables)

This session will focus on new findings related to the interaction of extractables/leachables with cells or proteins. The session will also focus on understanding the chemical basis of these interactions and potential preventive measures.

In addition, studies on the influence of contact time on proteins or cells are invited. What can be learned from other areas on this specific topic, e.g., fill finish and formulation? Can extractables be prevented or strategies devised to minimize their release? The session will focus on science-based procedures and analysis of extractables/leachables and how newly developed procedures have impacted bioprocessing.

Session 3: Sensors and Their Integration with Single-Use Technology

This session will focus on the development of sensors and challenges related to integration of sensors with single-use technology. Can we adapt or transform traditional sensor technology into a reliable and robust single-use sensor? Can sensor technology catch up with single-use technology implementation? The session will also focus on novel sensors for bioprocess or biomedical applications.

Session 4: Single-Use Advantages in Continuous and Connected Processing

This session will focus on how single-use technology has enabled or accelerated the development of end-to-end continuous processing for biopharmaceuticals production. Key question to be debated in this session include: Has single-use technology facilitated the integration of different process steps? What are the challenges associated with the development of perfusion processes and maintenance of high cell densities using single-use bioreactors? What are the challenges associated with implementing one or more connected steps or fully continuous downstream processes when processing high titers from perfusion/batch processes? What are the limitations of single-use equipment including analytical sensors in this space?

Studies addressing product quality concerns originating from SUS (e.g., bioburden, endotoxin, particulates and E/L) as well as new single-use solutions for robust and scalable continuous processing are encouraged.

Session 5: Single-Use Adoption for Cell and Gene Therapy Applications

Single-use systems are considered a promising technology for manufacturing viral gene therapies and modified cell therapies because they can facilitate rapid turnaround times between campaigns. This session will focus on the advancements made in this area and on examples where closed automated solutions have enabled commercial manufacture, ensured consistent quality and/or met commercial demand. At what stage in process development should we consider adoption of single-use equipment? Are there examples of novel technologies able to harvest, concentrate, wash while maintaining cell viability and quality.

Case studies demonstrating the impact of adoption of single-use technology on time-to-patient, reproducibility, reliability and scalability are particularly encouraged.

Session 6: Single-Use Performance

This session will focus on the generic challenges faced when operating single-use equipment and the proposed solutions. Questions we aim to address include: What are the current approaches to prevent leaks and improve product robustness? What are the current industry standards, what type of tests are conducted and what is the test sensitivity, to ensure the integrity of bags and assemblies? Can integrity requirements be met at point of use (POU) or are we introducing more risk? Case studies about supplier quality release method development as well as end user POU acceptance best practice are beneficial.

Studies of the correlation between chemical and physical properties of the polymer (e.g., film) and integrity (e.g., leak), impact of film blowing for integrity testing followed by gamma irradiation on physical/mechanical characteristics, as well as E/L, are especially welcome.

Pre-Conference Workshops

The aim of these workshops is to improve knowledge of a specific topic by proposing a series of presentations/lectures.

Current topics suggestions include:

  • Basics of polymers
  • Fundamentals of cell and gene therapy (fundamentals of cell therapy and gene therapy, terminology, process flow sheets for different therapies, manufacturing challenges)

Conference Organization

Co-Chairs:
Weibing Ding, Amgen
Martina Micheletti, University College London
Robert Repetto, Pfizer

Abstract Submission

Detailed session descriptions are available in the Session descriptions above.  Please use these descriptions to pre-select up to two sessions where you believe your work fits best.

Abstracts (one page maximum) that include specific results and conclusions to allow a scientific assessment of the proposed oral presentation are invited.  Please prepared your abstract according to this template: docx or doc.

Abstracts must be submitted electronically using the template provided at: THIS LINK.

Oral abstract submission deadline:                June 1, 2018
Poster abstract submission deadline:            June 15, 2018

Abstracts of all presentations will be made available to conference participants prior to the start of the conference.

Note:  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.

Awards will be presented for the overall best poster and for the top three student posters.

Major Sponsors

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Levels of Sponsorship

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Conference Venue

Snowbird Resort is nestled within the Little Cottonwood Canyon, in the Wasatch Range of the Rocky Mountains in the state of Utah. This mountain setting offers excellent meeting facilities, dining, accommodations and activities. Salt Lake International Airport (SLC) is approximately 29 miles away from Snowbird. Ground transportation options between Salt Lake International Airport and Snowbird include rental car, taxi (approximately $75-$85 one-way), and shuttle service (approximately $45 one-way and $82 round trip) with Canyon Transportation.

Conference participants will be housed in The Cliff Lodge that offers three restaurants, two lounges, two swimming pools, four hot tubs and a world-class spa.

Trail & Village Maps

Address:  9385 S. Snowbird Center Drive,  Snowbird, UT 84092-9000

Travel and Transportation

By Car:  To Snowbird from Salt Lake City International Airport
Take I-80 east to I-215 south. Take Exit 6 (6200 South) and go east on 6200 South, toward the mountains. This road will lead you straight to UT-210 and up Little Cottonwood Canyon to Snowbird.

General Information about ECI

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