Single Use Technologies VI

Established, Emergent, Agile, Sustainable?

An ECI Conference Series

September 10-13, 2023
Hyatt Regency Hotel
Boston, Massachusetts, USA

About this Conference

Single-Use Technologies VI is the sixth event of an ECI conference series started in 2015 and unique in its aim – to advance knowledge in the fundamental science and engineering underpinning Single-Use Technology (SUT). 

The conference will be a 4-day event and will target 100-120 attendees. The conference will have speakers and attendees 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. Regulators are also invited to speak and attend.

This conference will build on the success of the previous editions and will focus on four key themes: Established, Emergent, Agile, and Sustainable. “Established” and “Emergent” refer to both therapeutics (ie, established therapeutics like monoclonal antibodies as well as emergent cell and gene therapies) and single-use technologies (ie established films as well as emergent sensors). “Agile” encompasses operational change across the industry – how do we enable agility in our operations? “Sustainable” reflects the industry-wide intention to use SUT in a sustainable manner, and the need to tackle the challenge collectively.

This conference brings together a multidisciplinary community interested in collaborating openly towards the advancement, expansion, and environmentally responsible use of single-use technology in the bioprocessing industry. The organizing committee welcomes the submission of scientific work that is novel and high quality.

Conference Organizers

Conference Chairs

Magali Barbaroux (Sartorius)
Magali Barbaroux completed her Ph. D. at the University of Paris in Material Science, and Engineering She has over 25 years of experience in polymer science for healthcare applications. She started her career with research into silicone for drug delivery and migration of active substance through polymeric membrane. She joined Sartorius in 2000 and contributed to the development Single-Use products optimized for bioprocessing applications. She now belongs to the Sartorius Corporate Research and manages the Advanced Polymers related research programs, with a strong focus on environmental sustainability and opportunities brought by the New Plastic Economy in biotech applications.

Sheryl Kane (Takeda)
Sheryl Kane is the head of the Strategic Materials Assurance Group at Takeda in Lexington, MA. She has a B.A. in Chemistry and a Ph.D. in Bioengineering, with a focus on polymers. She spent the first half of her career in R&D related to medical devices, drug delivery, and filtration membranes, then moved into biotechnology to support single-use systems and raw materials for bioprocessing. She is focused on proactive raw material improvements and identifying and implementing solutions to material challenges within Takeda and the biotech industry.

Seongkyu Yoon (University of Massachusetts, Lowell)
Dr. Seongkyu Yoon is a Professor in the Francis College of Engineering at the University of Massachusetts (UMass), Lowell which he joined in 2010 after 15 years in industry. Currently, Dr. Yoon is co-director of Massachusetts Biomanufacturing Center, the UMass site director of the NSF/IUCRC/AMBIC, the co-PI of NSF/AccelNet/IBioNe (International Biomanufacturing Network), and the UMass technical lead for NIST-sponsored Manufacturing USA institute NIIMBL. Dr. Yoon founded the Massachusetts-based Biomanufacturing Innovation Institute for universities and companies. Yoon is leading a research group of systems and synthetic biology while conducting researches in platform process development for protein, gene and vaccine therapeutics. He completed his PhD at McMaster University (Hamilton, Canada).

Steering Committee Members

Weibing Ding (GSK)
Regine Eibl-Schindler (Zurich University of Applied Sciences)
Beth Junker (BioProcess Advantage LLC)
Gary Lye (University College London)
Ekta Mahajan (Genentech-Roche)
Martina Micheletti (University College London)
Robert Repetto (Pfizer)

Conference Agenda

Session Descriptions

Session “Established”

The established space includes both established technologies and established therapeutics. Over the past decade, single-use systems have gone from cutting-edge to the default technology for new facilities making protein therapeutics such as monoclonal antibodies. For these applications, the focus is on improvement and lifecycle management at both suppliers and end users. How do you set up a greenfield single-use facility? How do suppliers introduce new technologies and manage changes to existing technologies? How do end users improve their design libraries and incorporate new technologies? How do end users address risk (real and perceived) and regulatory considerations when making changes? Where do you want to see established single-use technologies go next?

Session Chairs:

Gary Gilleskie (NCSU)
Gary Gilleskie is the Executive Director of North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center (BTEC) – a unique center whose mission is to develop skilled professionals for the biomanufacturing industry. Since joining BTEC in 2007, Gary has developed and taught numerous courses in the area of downstream biopharmaceutical process development and manufacturing for university students, industry professionals, and various regulatory agencies throughout the world. Among those courses is Hands-on Single-use Processing for Biopharmaceuticals, a short course taught annually for industry professionals. Prior to joining BTEC, Gary spent 15 years in both the chemical and biopharmaceutical industries, most recently at Diosynth Biotechnology (now Fujifilm Diosynth Biotechnologies). He received his B.S. in chemical engineering from NC State University in 1986 and his Ph.D. in chemical engineering from the University of Minnesota in 1993.

Sandrine Egli (Lonza)
Sandrine Morgenstern-Egli is an Associate Director in the Single-Use Technology team within the Lonza global Manufacturing Process Technology and Innovation group. After a start in the field of stem cell research, she joined the pharmaceutical industry environment where she worked on the development of a continuous manufacturing process and on cell line
development within Novartis Pharma AG. She then transitioned to Hoffmann-La Roche Ltd where she started in the field of commercial manufacturing operation and held several roles in
technical operations such as facility start-up projects or technical transfers projects. Sandrine Morgenstern-Egli holds a Master of Pharmaceutical Biotechnology from the Zürich University of Applied Sciences, Switzerland.

John Puglia (ThermoFisher)

Session “Emergent”

The emergent space includes both emergent technologies and emergent therapeutics. While single-use systems are the default technology for many newer therapeutics such as cell and gene therapies and mRNA products, the new applications warrant a closer examination of their fitness for purpose. Many of the enabling technologies were developed for research purposes, and they are not as mature as those used for protein production. Others have been repurposed from protein production or medical device industry but may not perfectly meet emergent therapeutic needs. The supply base associated with these technologies is also emergent. In the technology space, what new technologies are under development? What are the technology and compliance gaps, and how are we addressing them as an industry? How are end users and academics using single-use technology to enable new therapeutic production? Where do you want to see emergent single-use technologies go next?

Session Chairs:

Mark Blenner (UDEL)
Dr. Blenner is an Associate Professor of Chemical & Biomolecular Engineering at the University of Delaware. Prior to that, he was the McQueen Quattlebaum Associate Professor of Chemical and Biomolecular Engineering at Clemson University. He received his PhD in Chemical Engineering from Columbia University in 2009 and completed three years of postdoctoral training as an American Heart Association Postdoctoral Fellow and an NIH NRSA Postdoctoral Fellow at Harvard Medical School and Children’s Hospital Boston. His research is broadly focused on engineering microbial and mammalian cells systems for the production of biopharmaceuticals, nutraceuticals, chemicals, and biosensors. He is applying synthetic biology and systems biology to improve mammalian cell line development and cell line stability.

Shawn Wang (Kite Pharma)
Shawn (Xueyuan) Wang is an Associate Director in Kite Pharma Process Development. He leads the raw material group in Kite’s PD focusing on new material development and implementation into Kite clinical programs. He has a B.S. in Biology from University of Science and Technology of China and Ph.D. in Polymer Engineering from the University of Akron. He started his career in a polymer film R&D company, then moved to the pharmaceutical industry to work as single use system SME. He supported the single use facility build up in both Genentech and Bayer before moving to Kite to focus on cell therapy applications.

Takeshi Nishiura (Northwest Fluid Solutions)
Takeshi Nishiura is the head of single-use technologies at Northwest Fluid Solutions.  He has a B.S. in Chemical Engineering from University of California, Los Angeles.  He has over 17 years of biotechnology industry experience, the bulk of which has been focused on making single-use systems successful in biologics and cell therapy manufacturing from the end user perspective.  He joined Northwest Fluid Solutions in 2022 and is now focused on applying his experience to the supplier side of the industry and providing robust bioprocessing solutions to serve customers and their patients.

Session “Agile”

One of the many benefits of single-use technology is the potential to adjust quickly to changes in market demands and operational requirements. Single-use technology can provide simplified and flexible production with less time, energy, labor, resources and capital. It is an agile technology that can allow patients around the world better access to new and existing medicines by enabling manufacturers to deliver these therapies faster.

Some of the questions we seek to discuss in this session are: How do you enable agility in a GMP facility? How do suppliers enable agility in their own technologies, products, and operations? What are the regulatory considerations that may support or limit agility? What are the fundamental concepts required to enable agility? What does agility mean to you?

Session Chairs:

Andrea Rayat (UCL)
Andrea Rayat is Associate Professor in Bioseparations and DSP at University College London (UCL). She holds Biochemical and Chemical Engineering degrees from UCL (PhD), TU Delft (MS), and UPLB (BS). She leads a research group that studies and develops scale-down methods to investigate primary recovery and membrane processes in the manufacture of biotech products. Her work interfaces with technology translation and knowledge exchange having previously secured an EPSRC Impact Acceleration award and Innovate UK’s Knowledge Transfer Partnership. The latter won for their team an Institution of Chemical Engineers (IChemE) global award in 2020. Currently, she is PI in a BBSRC project where she studies single use/re-usable membrane materials and the yield of vector production for gene therapy. At UCL, Andrea is the head of the department teaching committee and is director of the BEng/MEng Biochemical Engineering programs.

Christian Wood (Moderna)
Christian Wood is a Director of Critical Materials MS&T at Moderna, where he leads a group that supports the life cycle of single use consumables and raw materials. He’s worked in various process development and manufacturing support roles for over 18 years in biologics, cell therapy, and vaccine manufacturing. His work in process and technology development, capital projects, and manufacturing support has consistently had a strong emphasis on single use consumable design and optimization. He has BS and MEng degrees in Chemical Engineering from Cornell University.

Jeffrey Carter (Cytiva)
Jeff Carter has been a supplier to the bio/pharmaceutical manufacturing industry for over twenty-five years, and he has been with Cytiva/GE Healthcare since 2005, serving in R&D and Marketing capacities. His present role as Consumables Strategic Projects Leader is to lead initiatives that focus on augmenting quality and supply of our single use portfolio. He is active in organizations such as ASTM E55, ASME-BPE, and BioPhorum. He is Chairman Emeritus of the Board of BPSA. Dr. Carter holds a PhD degree from Penn State University in molecular microbiology.

Session “Sustainable”

This session will focus on the integration of environmental sustainability priorities and circularity opportunities in bioprocesses using single-use technology (SUT) and lifecycle analysis (LCA). It will include case studies along the product life cycle: raw material, design, manufacturing, use, end-of life (including recycling), transport, and systems analysis. Key questions that will be addressed in this session include: How to reduce environmental impact of SUTs? What are the levers and approaches to environmental impact reduction? What are the barriers and how can we overcome them as an industry? What does environmental sustainability mean to you?

Session Chairs:

Margaret Sobkowicz-Kline (UMLowell)
Meg Sobkowicz-Kline is a Professor of Plastics Engineering at UMass Lowell. She holds a B.S. and Ph.D. in Chemical Engineering from Columbia University and Colorado School of Mines, respectively. In 2010 she was awarded a National Research Council postdoctoral fellowship to study polymeric materials for photovoltaic applications at National Institute of Standards and Technology, and she joined UMass Lowell in 2011. Her research interests include renewable polymers, blends and composites, plastics processing and recycling, rheology, green chemistry, and climate change. At UMass Lowell she serves on the leadership team for the Office for Faculty Equity, aimed at increasing the participation and advancement of underrepresented groups in academic STEM careers. She is also the PI of an NSF research traineeship project focused on convergent graduate education in water and materials sustainability.

Philip Smith (GSK)

Nelly Montenay (Sartorius)
Nelly Montenay is Head of Material & Science for the Product development group in BPS Sartorius. Nelly is specialized in polymer sciences and polymer transformation with a strong background in film & tube extrusion. She received an Engineering degree in Polymer Sciences from the French ITECH Lyon Engineering School in 2003. With 20 years of experience in Polymer science, film development and product qualification testing, Nelly and her group are advocating Material sciences within Sartorius. With a strong interest in communication skills and people, Nelly plays also a key role in supporting projects & exchange within international groups.

Poster Committee

Caitlin Morris (UMLowell)

Stephanie Ketcham (BMS)
Stephanie Ketcham is a Principal Scientist for Bristol Myer’s Squibb’s BioProcess Technology Manufacturing Sciences and Technology team. She leads the upstream lab-based manufacturing support team for the single-use facility (SUF). The expanding scope of commercial and clinical molecules within the SUF brings new PAT technologies and innovative process strategies for biologics manufacturing. Stephanie has a Ph.D. in biology from Johns Hopkins University, where she trained as a cell biologist and biochemist. She transitioned from basic research science to bioprocessing while a post-doc at the FDA, focusing on common process changes and their impact to product quality.

Joy Xiaohui Chen (Entegris)
Joy Xiaohui Chen is a senior application engineer at Entegris, Life Sciences. She has over 15 years of life sciences industry experience, with expertise in single-use bioprocessing solutions such as single-use bag assemblies, membrane filters, and bioreactors for different biopharmaceutical applications. In her current role, she leads the conceptualization and development of application design and execution throughout the life cycle of new products in filtration. She establishes and maintains a network of technical collaborators to generate quality application content for Entegris’ Life Sciences platform. She has previously worked at GE Life Sciences (now Cytiva) and GE Global Research in a broad spectrum of areas including bioprocessing filtration, physiological monitoring, disease diagnostics and cell & gene therapy. She is an active member of BPSA and BPOG. She earned her B.S. in Electrical Engineering and Ph.D. in Biological Engineering.

Abstract Submissions

One-page abstracts should be submitted as soon as possible and no later than the deadlines noted below. 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 most relevant session topic for which you are submitting your abstract and whether the abstract should be considered for an oral or poster presentation.

The specific topics are (sessions are described above):
Session “Established”
Session “Emergent”
Session “Agile”
Session “Sustainable”

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

All abstracts should be submitted electronically HERE.

Please prepare your abstract according to this template: docx or doc.

Oral Presentation Abstract Deadline: January 15, 2023
Poster Presentation Abstract Deadline: June 30, 2023

Corporate Sponsors

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Boston, Massachusetts

Surrounded by the Atlantic Ocean and the Charles River, Boston offers an astounding number of activities to you to enjoy prior and post conference. These range from harbor cruises, exploring the U.S.S. Constitution, following the Freedom Trail, visiting museums and university campuses, taking in a game at Fenway Field, or just relaxing at the Boston Commons.

Boston Tea Party Ships & Museum

This floating museum features live actors and interactive exhibits, as well as a chance to dump tea overboard.

Freedom Trail

This 2.5-mile, self-guided tour of American Revolution sites starts at Boston Common and ends at the Bunker Hill Monument.

John F. Kennedy Presidential Museum & Library

Explore exhibits about pivotal moments such as the Kennedy-Nixon debate, the Cuban Missile Crisis, and the space program.

Samuel Adams Brewery

Taste limited-release pints and locally-made snacks in the brewery’s beer garden.

Museum of Fine Arts

Boston’s oldest, largest, and best-known art institution, this museum is renowned for its Impressionist paintings.

Fenway Park

This famous baseball park includes the 37-foot-tall left field wall known as the “Green Monster.”

Isabella Stewart Gardner Museum

A Venetian palace in the middle of Boston, this museum displays a collection of European, American, and Asian art.

Boston Common

Boston’s oldest public park offers a peaceful escape from the busyness of the city.

Boston weather: September is one of the best times of the year to be in Boston as summer shifts into fall. Expect pleasant temperatures and low precipitation.

Previous Conferences

Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
October 18-21, 2015 – Leesburg, VA, USA
Conference Chairs:
Ekta Mahajan, Genentech Inc., USA
Gary Lye, University College London, UK
Digital Archives

Single-Use Technologies II: Bridging Polymer Science to Biotechnology Applications
May 7-10, 2017 – Tomar, Portugal
Conference Chairs:
Ekta Mahajan, Genentech Inc., USA
Gary Lye, University College London, UK
Regine Eibl, Zurich University of Applied Science, Switzerland
Digital Archives

Single-Use Technologies III: Scientific and Technical Advancements
September 23-26, 2018 – Snowbird, Utah, USA
Conference Chairs:
Weibing Ding, Amgen, USA
Martina Micheletti, University College London, UK
Robert Repetto, Pfizer, USA
Digital Archives

Single-Use Technologies IV: Building the Future Webinar
May 20, May 25, June 1, 2021 – Webinar
Conference Chairs:
Magali Barbaroux, Sartorius, France
Weibing Ding, GSK, USA
Martina Micheletti, University College London, UK
Digital Archives

Single-Use Technologies V: Building the Future
March 20-23, 2022 – Marseille, France
Conference Chairs:
Magali Barbaroux, Sartorius, France
Martina Micheletti, University College London, UK
Digital Archives

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.

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