The steady adoption of single-use technologies and subsequent move toward continuous processing (CP) for clinical and commercial manufacture has created a great need to evaluate the risks, challenges, opportunities and strategies for implementing these
types of technologies into modern day bioprocessing.
Cambridge Healthtech Institute’s Fifth Annual Single-Use Technologies and Continuous Processing conference will once again gather technology and equipment providers, end users, and regulators to discuss innovative approaches to
current challenges, update companies on the trends in technology, share case studies on successful implementation, and ultimately identify how to derive as much value as possible from these technological advances.
Final Agenda
SUNDAY, JANUARY 7
4:00 - 6:00 pm Pre-Conference Registration
MONDAY, JANUARY 8
7:00 am Registration and Morning Coffee
9:00 Welcome by Conference Organizer
Kip Harry, Senior Conference Director, Cambridge Healthtech Institute
9:05 Chairperson’s Opening Remarks
Dennis Powers, Director, Sales Engineering, G-CON Manufacturing
9:10 A Fully Automated Biopharmaceutical Manufacturing Plant: Process Design, Modeling, and Control
Richard D. Braatz, Ph.D., Edwin R. Gilliland Professor of Chemical Engineering, Massachusetts
Institute of Technology
This presentation describes the strategy used in the design of a fully automated small-footprint biopharmaceutical manufacturing plant that produces multiple biologics. Dynamic models are constructed for the design of the equipment for the unit operations
and their operations including the real-time control of biologic drug production. An opportunity is the use of a “virtual” plant for the dynamic operations of the entire end-to-end biomanufacturing process. The virtual plant can guide
the selection of a control strategy for each critical quality attribute (CQA), design of startup and shutdown operations, and control systems design.
9:50 Challenges and Limitations of Continuous Processing and Use of Disposables
Berthold Boedeker, Ph.D., Chief Scientist, Global Biologics Development,
Bayer Pharma AG
Continuous processing in combination with use of disposables has made significant advances in the past years. However, despite many advantages to standard processing, there are still many hurdles ahead of us, before these technologies will be suitable
for routine production. This talk will summarize several aspects of necessary improvements as well as some risks associated with these technologies, which are often underestimated in their impact, such as process validation, process characterization
and scale-down models.
10:20 Networking Coffee Break
10:45 A Single-Use Strategy to Enable Manufacturing of Affordable Biologics
Renaud Jacquemart, Ph.D., BioPharma Downstream Process Specialist, Natrix
Separations
Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production. This case study summarizes how a single-use strategy including a holistic process approach, continuous operation, full
utilization of media life (up to 100 cycles per batch) and high-throughput chromatography (residence time ≤6s and loads in kg/L media) can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for
affordable biologics.
11:15 Integrated Continuous Manufacturing Progress and the Life Sciences Industry “Fad or Reality”
Robert Dream, Ph.D., Managing Director, HDR Company LLC
11:45 Flexible Facility Designs Complementing Continuous Processing
Dennis Powers, Director, Sales Engineering, G-CON Manufacturing
In the future, traditional cleanroom environments and facilities will need to be more agile to adapt with manufacturers’ product portfolio and throughput needs, and will require faster implementation in order to respond to new opportunities
and demand around the world. The discussion will focus on advancements in single-use technologies and continuous manufacturing, future manufacturing and facility needs, and innovative cleanroom and facility designs being developed to address
these needs.
12:15 pm Enjoy Lunch on Your Own
2:00 Chairperson’s Remarks
Adam Goldstein, MSc, Principal Scientist, Global Technology, Roche/Genentech
2:05 Technology Advances in Single-Use Technologies
Adam Goldstein, MSc, Principal Scientist, Global Technology, Roche/Genentech
This presentation will focus on challenges single-use applications currently have and may have in the future of biomanufacturing. I will also discuss advances in single-use technologies, with particular emphasis on bulk freeze applications.
2:35 Challenges Faced by the End Users during the Qualification of SUS
Ben Jeyaretnam, E&L Analytical Lead, Sanofi
Recently the pharmaceutical industry has been increasingly using single-use systems (SUS). Before a SUS can be used in the manufacturing process, it needs to be qualified for use by a predetermined process. This presentation will
discuss a variety of challenges that the end user faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, E&L study execution,
analytical challenges, and the potential impact of unexpected E&L study results will be presented.
3:05 Transition to BuzZ Sessions
3:15 BuzZ Sessions with Refreshments
Join your peers and colleagues for interactive roundtable discussions.
5:00 Intensified mAb Polishing: Linking single pass TFF with Anion Exchange Chromotography
April Wheeler, PhD, Technology Manager, TFF and Clarification, Process Solutions, Millipore Sigma
5:30 Single-Use Considerations for the High-Yield Production of Glyco-Optimized Biopharmaceuticals with Human Cells in Perfusion Bioreactors
Steffen Kreye, Ph.D., Associate Director, USP, Glycotope GmbH
The GlycoExpress® (GEX®) technology displays a set of human cell lines for the production of glyco-optimized human biopharmaceuticals. Case studies for GEX® processes will be highlighted with special focus on single-use applicability,
continuous processing and product quality. In a first section, data of a process transfer from a 200 L stainless steel to a 1000 L single-use bioreactor for a continuous cell culture application will be discussed. As a second part,
a 10 mL down-scale system for perfusion cultivation in a single-use microbioreactor will be introduced and its application for process development evaluated.
6:
00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing
7:15 Close of Day
TUESDAY, JANUARY 9
8:00 am Registration and Morning Coffee
8:30 Chairperson’s Remarks
Jonathan Bones, Ph.D., Principal Investigator, Characterisation and Comparability Laboratory, National Institute for Bioprocessing Research and Training
8:35 SU Sensors on FlexAct UD, a SU platform for UF/DF: In-Process Testing and Evaluation of Robustness
Nikhil Ramsubramaniam, Ph.D, Senior Scientist, Merck
Robust single-use sensors could not only enable initiation of continuous monitoring and process control in a time effective manner but also but also enable establishment of an end-to-end single use bioprocess when coupled with other
disposable technologies for different unit operations. This presentation will focus on robustness evaluation of single-use sensors for pH, flow, pressure and conductivity used in conjunction with the Sartorius FlexACT UD platform.
Results obtained from robustness evaluation, performed under wide variety of process conditions using single-pass, flow-in-loop and offline experiments indicate that SU sensor performance was well within the tolerance acceptable
for bioprocess. Various opportunities for integrating the SU sensors onto continuous bioprocess platform with integrated upstream and downstream unit operations at scale will be discussed.
9:05 Continuous Chromatography for the Improvement of the Purification of Proteins and Peptides
Thomas Müller-Späth, Ph.D., Senior Scientist, Institute for Chemical and Bioengineering, ETH Zürich
Continuous chromatography processes allow a number of improvements in the downstream processing of biomolecules including increase in throughput, improved stationary phase utilization, improved yield and reduced buffer consumption.
In this talk a brief overview of the different process concepts including CaptureSMB and MCSGP is presented and their strengths and weaknesses with respect to different applications is discussed. The concepts are also reviewed
in the context of integration into continuous downstream manufacturing. The application examples of monoclonal antibody Protein A capture using a twin-column countercurrent CaptureSMB process and polishing using a twin-column MCSGP
process are discussed in greater detail.
9:35 SELECTED POSTER PRESENTATION: The Utilization of a Novel Online Cell Quantitation Microscopic Technology in Cell Culture Process Development
Jianxin Sun, Ph.D., Senior Scientist, Boehringer Ingelheim
9:50 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Large-Scale Extractable and Leachable Analysis of Single-Use Bioreactors for Biopharmaceutical Manufacture
Jonathan Bones, Ph.D., Principal Investigator, Characterisation
and Comparability Laboratory, National Institute for Bioprocessing Research and Training
This presentation will describe the characterization of extractables and leachables from disposable bioreactors within a public-private partnership.
11:30 Presentation to be Announced
12:00 pm PANEL DISCUSSION: Advances in Bioprocess Technologies and Analytics
Moderator:
Jonathan Bones, Ph.D., Principal Investigator, Characterisation and Comparability Laboratory, National Institute for Bioprocessing Research and Training
Panelists:
Nikhil Ramsubramaniam, Ph.D., Senior Scientist, Merck
Thomas Müller-Späth, Ph.D., Senior Scientist, Institute for Chemical and Bioengineering, ETH Zürich
12:30 Close of Single-Use Technologies and Continuous Processing Conference