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9月04日
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12:00pm - 1:00pm

Pre-Conference Symposia Registration

Showing of Streams
Showing of Streams
12:00pm - 1:00pm 60 mins
Pre-Conference Symposia Registration
1:00pm - 1:10pm 10 mins
Cell Line Development & Engineering
Chairperson's Opening Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
1:00pm - 1:15pm 15 mins
New Technologies for Viral Inactivation/Clearance
Chairperson's Opening Remarks
1:00pm - 1:15pm 15 mins
Continuous Bioprocessing
Chairperson's Remarks
1:00pm - 1:15pm 15 mins
PAT in Biologics and Advanced Process Controls
Chairperson's Remarks and Short Presentation: Managing Biologics Process Analytical Technology in Pfizer
  • Keith Davis - Principle Scientist, Analytical R&D, Pfizer
more

Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.

1:00pm - 2:00pm 60 mins
Process Intensification & Connected Processing
The Transformation to Excellence - How to Leverage Lean Principles to Improve Single-Use Assembly Product Quality and Supply Security
  • William Faria - Head of Danvers Operations Sara Bell, Senior Marketing Manager, Single-Use Solutions, Millipore Sigma
more
1:00pm - 1:15pm 15 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Opening Remarks
  • Thomas Bollenbach - Chief Technology Officer, Advanced Regenerative Manufacturing Institute
more
1:00pm - 1:15pm 15 mins
Raw Materials
Chairperson's Opening Remarks
1:00pm - 1:15pm 15 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Chairperson's Opening Remarks
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more

"Non-communicable diseases are a slow-motion disaster...these are the diseases that break the bank. Left unchecked, they had the power to devour the benefits of economic gains." This 2011 statement by former WHO Director General Margret Chan points directly at the need and the opportunity for biomedical advancements and the demand for affordable biotherapeutics enabled among other aspects by efficient manufacturing of those products for patients around the globe. The seminar will discuss healthcare priorities and provide selected reviews of technology: cells, the drivers of productivity; harvesting step improvements fixing the weakest link in the process chain; intensification of the whole integrated process including the outlook on continuous processing; not the least, an insight in the regulatory maze upon process changes will call for the need to, finally, address local administrative obstacles that hardly add any value to the spread of most powerful therapies in our fight of non-communicable disease. Join the authors of "Biopharmaceutical Processing" to get an update on the key opportunities and challenges in our industry. And get a copy of the book in the process...

1:00pm - 1:15pm 15 mins
3M Pre-Conference Symposia
Chairperson's Opening Remarks
1:10pm - 1:40pm 30 mins
Cell Line Development & Engineering
Effect of RNA Epigenetics on Recombinant Protein Production
  • Niall Barron, PhD - Director, National Institute for Cellular Biotechnology
more
1:15pm - 1:45pm 30 mins
New Technologies for Viral Inactivation/Clearance
Virus Inactivation with Non Eco-Toxic Sugar-Based Detergents
  • Shawn Liu, PhD - Chief Scientist & Department Head, Bayer Healthcare LLC
more
1:15pm - 2:00pm 45 mins
Continuous Bioprocessing
Multi-clone Evaluation of Product Quality Attributes in an Integrated Continuous Biomanufacturing Platform: Upstream Intensification and Downstream Performance
  • Wenqin He, PhD - Bioprocess Development Scientist, Continuous Manufacturing Skill Center, Sanofi Genzyme
more
1:15pm - 1:45pm 30 mins
PAT in Biologics and Advanced Process Controls
PAT for Biologics: Monitoring and Control of Continuous Processing
  • Bhumit Patel - Associate Principal Scientist, Bioprocess Development, Analytics & Automation, Merck
more

Continuous processing for biologics is the way to overcome production challenges in addition to generating consistent product quality.  Process analytics is key for the characterization of complex biologics such as mAbs as well as providing proper process control.  Some PAT tools that will be highlighted are on-line U/HPLC and in-line MALS.  In addition, MAM via peptide mapping provides critical information on product quality at a molecular level.

1:15pm - 1:45pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Keynote Address - Engineered Tissue Manufacturing: Lessons Learned from Large Scale Commercialization
  • Katie Faria - Director, Product and Process Development, Organogenesis Inc., USA
more
1:15pm - 3:15pm 120 mins
Raw Materials
Session One
  • Omer Butt - Director, CMC Regulatory Affairs, Athersys, Inc, USA
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
more
  • Elimination of variations, especially in starting and raw materials/ ancillary materials and manual manufacturing steps
  • GMP-grade raw materials
  • Regulatory guidance surrounding raw materials -  USP Chapter <1043>, <92> and EMA's Ph. Eur. General Chapter 5.2.12
  • Automated systems linked to the removal of variation in raw materials
  • Developments in manufacturing augmenting a greater need for higher quality raw materials and customised raw materials
  • Assessment of origin and impurity profiles
  • Best practise for providing documented evidence of purity, potency, consistency and stability
  • Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing
  • Analytical testing
1:15pm - 1:45pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Disease and Healthcare Priorities Around the Globe
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
1:15pm - 2:00pm 45 mins
3M Pre-Conference Symposia
TBD
1:40pm - 2:10pm 30 mins
Cell Line Development & Engineering
Assessment of Edited CHO Cell Performance and Target Identification Through Transcriptomic Profiling
  • Philip Probert, PhD - Senior Upstream Scientist, National Biologics Manufacturing Centre, Center for Process Innovation
more
1:45pm - 2:45pm 60 mins
New Technologies for Viral Inactivation/Clearance
The Use of Detergents in Viral Inactivation - Case Study on a Patented ECO Alternative
  • Alexis Henry, MSc. - Senior Associate Scientist, Biogen
more
1:45pm - 2:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Advanced Process Analytics and Predictive Modelling for Process Performance Monitoring and Control
  • Julian Morris - Technical Director, University of Strathcylde
more

The presentation will address the analytical and production and quality assurance challenges, Quality and will set the scene through a series of highlighted themes: (i) pharmaceuticals development and production - a Systems view; (ii) challenges for data analytics and informatics systems and the impact of process and product variability, "where is the Variability, the cost of variability and impact on quality"; calibration maintenance and transfer, with case studies highlighting coping with multiplexed instruments, different probes and temperature-disturbed spectra using UV spectroscopy; calibration transfer between Lab and production plant; predictive modelling in fermentation scale-up; and the use of software / virtual sensors (Predictive Analytics) as an opportunity for Bio-processing.

1:45pm - 2:15pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Regulatory Considerations for Tissue Engineered Product Development
  • Yong Fan - Senior Consultant, A2Z Reg Solutions, USA
more
1:45pm - 2:15pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Cell Line Development
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
2:00pm - 2:45pm 45 mins
Continuous Bioprocessing
Challenges in Mid and Late Phase Downstream Process Development of Complex Glycoproteins and Impact of Implementing Continuous Processing Concepts
  • Paul Langevin - Associate Director, Amicus Therapeutics
more
2:00pm - 2:45pm 45 mins
3M Pre-Conference Symposia
TBD
2:10pm - 2:40pm 30 mins
Cell Line Development & Engineering
Stable Cell Line Development Using CRISPR and TARGATT™ Technologies
  • Ling-Jie Kong, PhD - Vice President, Applied StemCell Inc
more
2:15pm - 2:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Real Time Online Chromatography Monitoring of Product Quality Attributes for Biologics Continuous Manufacturing Process
  • Gang Xue - Scientific Director, Process Analytics, Amgen
more
2:15pm - 2:45pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Multi-platform-based Characterization of Cell Products and Processes: Identification of CQAs and Application of QbD Principles
  • Carolyn Yeago - Associate Director of Research, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, USA
more
2:15pm - 2:45pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Cell Separation and Product Harvesting Methods
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
2:40pm - 3:10pm 30 mins
Cell Line Development & Engineering
Optimizing ZFN-mediated Glutamine Synthetase Gene Knockout in CHO Cell Line Generation
  • Yang Ou, PhD - Post Doc Fellow, Merck & Co., Inc
more
2:45pm - 3:15pm 30 mins
New Technologies for Viral Inactivation/Clearance
Minimizing Resources in Developing Commercial Virus Filtration Processes
  • Daniel Strauss, Ph.D. - Senior Scientist, Asahi Kasei Bioprocess America, Inc.
more
2:45pm - 3:15pm 30 mins
Continuous Bioprocessing
Holistic Development of Intensified Mab Processes for Higher Productivity and Improved Economics
  • Michael Felo - Director, Downstream Process Integration, MilliporeSigma
more
2:45pm - 3:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Mapping Future Technology Needs for Real Time Release Testing
  • Udayanath Aich, Ph.D. - Principal Scientist, Bioanalytics, Sanofi-Genzyme
more

Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG's ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA's and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.

2:45pm - 3:15pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Role of Data Management and Artificial Intelligence in Automation of Biomanufacturing Process Development
2:45pm - 3:15pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Networking Refreshment Break
2:45pm - 3:30pm 45 mins
3M Pre-Conference Symposia
TBD
3:10pm - 3:40pm 30 mins
Cell Line Development & Engineering
Networking Refreshment Break
3:15pm - 4:00pm 45 mins
New Technologies for Viral Inactivation/Clearance
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
Continuous Bioprocessing
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
Raw Materials
Afternoon Coffee Break
3:15pm - 3:45pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Navigating the Regulatory Maze Upon Process Changes
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
3:30pm - 4:30pm 60 mins
3M Pre-Conference Symposia
TBD
3:40pm - 4:10pm 30 mins
Cell Line Development & Engineering
Rethinking Clonality Using Modeling Approaches
  • Huong Le, PhD - Process Development Senior Scientist, Amgen, Inc
more
3:45pm - 4:15pm 30 mins
Continuous Bioprocessing
High Cell Density Perfusion Process of HEK 293 Cells
  • Veronique Chotteau, PhD - Director of VINNOVA Competence Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO and Principal Investigator, KTH - Royal Institute of Technology
more

Continuous bioprocess operated at high cell density has the potential to be a highly effective production system. We have developed a fully integrated process, including high cell density cultivation and purification, for CHO cells within our new competence center AdBIOPRO, a collaboration between several Swedish and international academia and industries. The system is based on a bioreactor volume of 200 mL, which considerably alleviates process development. CHO cells are the workhorses of the biopharmaceutical field however human cells, such as HEK293 cells, might bring important advantages, such as the production of more human-like posttranslational modifications and potentially alleviate the production of difficult-to-produce molecules. This potential was evaluated within the Wallenberg Centre for Protein Research in collaboration with MedImmune. To evaluate the ability of these cells to express difficult-to-produce proteins, we have benchmarked them against CHO cells for 30 selected proteins, revealing a higher success rate in HEK 293 system. A high cell density perfusion process for HEK 293 cells using Alternating Tangential Flow filtration was developed for the production of the model protein erythropoietin (EPO). In this process, the cells were stably maintained at a density of 80 to 100 x 106 cells/mL while the EPO cell specific productivity was comparable to lower cell density (e.g. 20 x106 cells/ml). The perfusion rate could be reduced down to 1 reactor volume per day alleviating the manufacturing and a systematic feeding strategy for perfusion was developed. HEK293 cells are more shear sensitive than CHO cells, and can be affected by the shear stress from the hollow fiber filter-based cell separation system. This effect was deciphered from a mechanistic study and by transcriptomics analysis. The ability to express difficult-to-produce proteins and to achieve very high cell densities with productivity comparable to low density processes make HEK293 cells an attractive system for the production of biopharmaceuticals which are challenging for CHO cells.

3:45pm - 4:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Inline Amidite Identification Using FTIR For Antisense Oligonuclueotide (ASO) Manufacturing
  • Elliott Schmitt, PhD - Scientist II, Analytical Development, Biogen
more

Nucleotide phosphoramidites (amidites) are used as building blocks during antisense oligonucleotide (ASO) synthesis. Synthesis of ASO drug substance is performed by flowing the correct sequence of amidite solution through the synthesis column one amidite at a time. Identification of the incoming amidite solution is required to confirm the synthetic sequence in real time and to quickly notify operators of non-conformance if one occurs. This work presents a method for identifying starting material amidites for ASO drug substance manufacturing. The method utilizes Fourier transform infrared spectroscopy combined with multivariate classification method for online identification. PLS-DA was implemented to successfully classify different amidite solutions prior to entering the synthesis column. Discussion will present this method as a platform technology solution for quality control of antisense oligonucleotide manufacturing for pharmaceutical industry.

3:45pm - 4:15pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Integrated, Closed System PAT Analytics for Advanced Auto Feedback Control of CPPs in Single Use Bioreactors - Reactive Analytics
3:45pm - 5:50pm 125 mins
Raw Materials
Session Two
  • Mithu Majumder - Project Manager, RoosterBio Inc., USA
more
  • Elimination of variations, especially in starting and raw materials/ ancillary materials and manual manufacturing steps
  • GMP-grade raw materials
  • Regulatory guidance surrounding raw materials -  USP Chapter <1043>, <92> and EMA's Ph. Eur. General Chapter 5.2.12
  • Automated systems linked to the removal of variation in raw materials
  • Developments in manufacturing augmenting a greater need for higher quality raw materials and customised raw materials
  • Assessment of origin and impurity profiles
  • Best practise for providing documented evidence of purity, potency, consistency and stability
  • Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing
  • Analytical testing
3:45pm - 4:15pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Search for Process Intensification and Simplification
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
4:00pm - 4:30pm 30 mins
New Technologies for Viral Inactivation/Clearance
Viral Clearance Validation Across Continuous Capture Chromatography
  • Srinivas Chollangi, PhD - Manager, Bristol-Myers Squibb
more
4:10pm - 4:40pm 30 mins
Cell Line Development & Engineering
HT-NIC, a Novel High-Throughput Nanowell-Based Image-Verified Cloning Platform for Fast Generation of Clonal Production Cell Lines with Integrated Monoclonality Proof
  • Volker Sandig, PhD - Chief Scientific Officer, ProBioGen GmbH
more
4:15pm - 4:45pm 30 mins
Continuous Bioprocessing
Development of a Continuous Polishing Step for a Monoclonal Antibody Using Size-Exclusion Simulated Moving Bed Chromataography
  • George Weeden Jr. - Process Engineer III, Sanofi
more

The simulated moving bed (SMB) mode of operation can increase resin productivity by an order of magnitude compared to the standard batch mode of operation. It can also achieve higher monomer yield and higher purity with lower solvent consumption than batch operation. SMB operating parameters (flowrates and step time) are designed only using parameters obtained from batch mode operation.

4:15pm - 4:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Integrating Raman Spectroscopy in the Manufacturing of Biotherapeutics
  • Peter Slade - Senior Principal Scientist, Bioprocess R&D, Pfizer
more

Chemometric models were developed to quantitate in real-time both glucose and lactate concentrations during IgG manufacturing. A feedback loop was developed, in which glucose and lactate concentrations were used to control glucose feeds. High-lactate process conditions were run with this two factor feedback control, results demonstrated that a culture could be shifted from lactate production to lactate consumption. For downstream processing, Raman spectroscopy was integrated into a continuous manufacturing skid. Models were developed to accurately measure titer at various points in the purification process.

4:15pm - 4:45pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Automation and Robotics in Large-Scale Engineered Tissue Manufacturing
4:15pm - 5:15pm 60 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Current Achievements, Future Opportunities and Challenges with Integrated Continuous Bioprocessing
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
4:30pm - 5:00pm 30 mins
New Technologies for Viral Inactivation/Clearance
Demonstrating Viral Clearance for a Novel Approach to Continuous Viral Filtration
  • Tarl Vetter, PhD - Senior Scientist, Sanofi
more
4:30pm - 6:00pm 90 mins
3M Pre-Conference Symposia
Round table
4:40pm - 5:10pm 30 mins
Cell Line Development & Engineering
Implementing a Cell Line Development Platform in End-to-End Automation Fashion
  • Xiaoyan Tang, MD - Senior Scientist, Cell Line Development, Merck & Co., Inc.
more
4:45pm - 5:15pm 30 mins
Continuous Bioprocessing
Late Breaking Presentation
4:45pm - 5:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Late Breaking Presentation
4:45pm - 5:15pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Adherent Cell Manufacturing Matters: Production Platform and Media Strategies Drives Cell Production Economics
  • Jon A. Rowley, Ph.D. - Chief Executive & Technology Officer, RoosterBio Inc.
more
5:00pm - 5:30pm 30 mins
New Technologies for Viral Inactivation/Clearance
Continuous Low Ph Viral Inactivation for mAb Production Processes
5:10pm - 5:40pm 30 mins
Cell Line Development & Engineering
Panel Discussion
5:15pm - 6:00pm 45 mins
Continuous Bioprocessing
Panel Discussion
5:15pm - 6:00pm 45 mins
PAT in Biologics and Advanced Process Controls
PANEL DISCUSSION: Control Strategies and PAT Implementation in Biomanufacturing
  • Jeff Doyle - Manager, PAT Projects, Pfizer
  • Myra Coufal, PhD - Principal Scientist, Process Analytics, Digital Integration and Predictive Technologies, Amgen
  • Rob Guenard, PhD - Senior Director, Global Manufacturing Science, Biogen
more
5:15pm - 5:50pm 35 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Panel Discussion - Title TBD
  • Jon A. Rowley, Ph.D. - Chief Executive & Technology Officer, RoosterBio Inc.
more
5:15pm - 5:45pm 30 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Panel Discussion - What are the Major Pain Points Driving Biopharma Manufacturing Approaches for the Next Decade?
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
5:30pm - 6:00pm 30 mins
New Technologies for Viral Inactivation/Clearance
Panel Discussion
5:45pm - 6:00pm 15 mins
Pre-Conference Symposium #8 - The Future Demand and Opportunity for Biotherapeutic Development - How Advanced Approaches to Process Intensification Can Help the Case!
Chairperson's Recap and Closing Remarks
  • Gunter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
5:50pm - 6:00pm 10 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Closing Remarks and Look Ahead
  • Thomas Bollenbach - Chief Technology Officer, Advanced Regenerative Manufacturing Institute
more
5:50pm - 6:00pm 10 mins
Raw Materials
Chairperson's Closing Remarks and Look Ahead
6:00pm - 7:00pm 60 mins
Main Conference
Drinks Reception
6:00pm - 8:00pm 120 mins
An Evening of Diversity and Inclusion
PANEL DISCUSSION: Lead the Way: How to Champion Diversity and Inclusion in Life Sciences
more

We all agree that diversity and inclusion is an integral part of a successful organization's culture. What can you do to make sure that diversity of race, gender, sexual orientation, backgrounds and perspectives is part of your company's DNA? Hear from industry executives who are leading the way by implementing diversity and inclusion programs at their companies and organizations. Panelists will discuss what it takes to be a leader that drives diversity throughout an organization, and other actionable takeaways to get conversations about inclusion moving throughout your organization.


Roundtable Reception

Following the panel, join attendees for cocktails and conversation at an interactive networking reception. Members of the life science community who are forging the path for diversity will lead roundtable discussions throughout the room. Meet a potential mentor, connect with other attendees, and have substantive conversations about diversity and inclusion.


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