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MAIN CONFERENCE DAY ONE
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MAIN CONFERENCE DAY ONE
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7:00am - 8:00am60 mins
Coffee & Registration
8:00am - 8:05am5 mins
Plenary Session
Conference Opening and Welcome
8:00am - 9:15am75 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing
- James Dean Vogel - Founder and Director , The BioProcess Institute
8:05am - 8:40am35 mins
Plenary Session
Innovate to Transform - From Good to Great Biomanufacturing
- Thomas Seewoester, PhD - Vice President Site Operations, Amgen, Inc.
8:40am - 9:15am35 mins
Plenary Session
New Modalities, New Players, New Technologies - How Can We Succeed in an Exponential Future?
- Wolfram Carius - Executive Vice President Pharmaceuticals Product Supply (Chemicals, Pharma, Biotech, Devices), Bayer AG
9:15am - 9:55am40 mins
Networking Break
Networking Refreshment Break
9:15am - 9:55am40 mins
Snack and Learn
Accelerated High Performance Cell Line Development at SBL
- John Gill IV - Director, Cell Line Development, Samsung Biologics
9:55am - 10:00am5 mins
Track 1: Cell Line Development & Engineering
Chairperson's Opening Remarks
- Karthik Balakrishnan - CEO, Nodexus Inc
9:55am - 10:00am5 mins
Track 2: Cell Culture & Upstream Processing
Chairperson's Opening Remarks
- Brian Horvath - Director of Upstream Process Development, NGM Biopharmaceuticals
9:55am - 10:00am5 mins
Track 3: Recovery & Purification
Chairperson’s Opening Remarks
- Susan Dana Jones, Ph.D. - Senior Vice President, Product Development, Harpoon Therapeutics
9:55am - 10:00am5 mins
Track 5: Intensified & Continuous Processing
Chairperson's Opening Remarks
- Brian Horvath - Director of Upstream Process Development, NGM Biopharmaceuticals
9:55am - 10:00am5 mins
Track 6: Cell & Gene Therapy Manufacturing
Chairperson’s Opening Remarks
- Ali Mohamed - VP, CMC, Immatics, USA
9:55am - 10:00am5 mins
Track 7: Analytical & Quality
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 8: Phase-Appropriate Process Development
Chairperson’s Opening Remarks
- Susan Dana Jones, Ph.D. - Senior Vice President, Product Development, Harpoon Therapeutics
9:55am - 11:30am95 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing - Cont'd
- James Dean Vogel - Founder and Director , The BioProcess Institute
10:00am - 10:30am30 mins
Track 1: Cell Line Development & Engineering
Rapid Generation of Production Cell Lines with Superior Titers and 99% Monoclonality for Complex Antibody Molecules
- Anupam Singhal, PhD - Product Manager, Antibody Therapeutics, Berkeley Lights, Inc.
10:00am - 10:30am30 mins
Track 2: Cell Culture & Upstream Processing
Controlling Glucose concentration in the Bioreactor using Soft Sensors
- Kenneth Lee, PhD - Scientist II, MedImmune
10:00am - 10:30am30 mins
Track 3: Recovery & Purification
What Data is Being Captured in Research? How do They Communicate it to Development?
- David Kahn, Ph.D. - Vice President of Biopharmaceutical Development, Macrogenics
10:00am - 10:30am30 mins
Track 5: Intensified & Continuous Processing
Controlling Glucose concentration in the Bioreactor using Soft Sensors
- Kenneth Lee, PhD - Scientist II, MedImmune
10:00am - 10:30am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Update on Validation Considerations for Rapid Mycoplasma Detection using qPCR: Regulatory Queries and Responses
- Mike Brewer - Director, Global Principal Consultant, Regulatory, Thermo Fisher Scientific
10:00am - 10:30am30 mins
Track 7: Analytical & Quality
Update on Validation Considerations for Rapid Mycoplasma Detection using qPCR: Regulatory Queries and Responses
- Mike Brewer - Director, Global Principal Consultant, Regulatory, Thermo Fisher Scientific
10:00am - 10:30am30 mins
Track 8: Phase-Appropriate Process Development
What Data is Being Captured in Research? How do They Communicate it to Development?
- David Kahn, Ph.D. - Vice President of Biopharmaceutical Development, Macrogenics
10:25am - 10:30am5 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Chairperson's Opening Remarks
- Craig Curless - Senior Director of Manufacturing, Macrogenics, Inc.
10:30am - 11:00am30 mins
Track 1: Cell Line Development & Engineering
Accelerating Cell Line Development With Rapid Single Cell and Population Level Discovery
- Kim Le - Senior Scientist & Group Leader, Amgen
10:30am - 11:00am30 mins
Track 2: Cell Culture & Upstream Processing
Monitoring Cell Populations and Tunable Promoters for Robust Continuous Upstream Processing
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
10:30am - 11:00am30 mins
Track 3: Recovery & Purification
Physics-based Modeling: Going from Sequence to Predicting Developability Characteristics
- Saeed Izadi, Ph.D. - Scientist, Pharmaceutical Development, Genentech
10:30am - 11:00am30 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Technology Road Map Implementation in a Multi Product Facility – Challenges and Lessons Learned
- Padmadhar Madupu - Technical Manager, Pfizer
10:30am - 11:00am30 mins
Track 5: Intensified & Continuous Processing
Monitoring Cell Populations and Tunable Promoters for Robust Continuous Upstream Processing
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
10:30am - 11:00am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Augmenting Automated Analytics for Cell & Gene Therapy Manufacture
- Veeren Chauhan - Nottingham Research Fellow in Bio-inspired Therapeutics, University of Nottingham, USA
10:30am - 11:00am30 mins
Track 7: Analytical & Quality
Augmenting Automated Analytics for Cell & Gene Therapy Manufacture
- Veeren Chauhan - Nottingham Research Fellow in Bio-inspired Therapeutics, University of Nottingham, USA
10:30am - 11:00am30 mins
Track 8: Phase-Appropriate Process Development
Physics-based Modeling: Going from Sequence to Predicting Developability Characteristics
- Saeed Izadi, Ph.D. - Scientist, Pharmaceutical Development, Genentech
11:00am - 11:30am30 mins
Track 1: Cell Line Development & Engineering
Introducing BioPAT® Spectro - Raman spectroscopy meets high throughput bioprocessing and SU manufacturing
- Svea Cheesman - Product Manager PAT, Sartorius
11:00am - 11:30am30 mins
Track 2: Cell Culture & Upstream Processing
Four Steps Toward Connected Biomanufacturing: A Pragmatic Approach to Start to Finish Processing
- Avril Vermunt - Connected Biomanufacturing Program Manager, GE
11:00am - 11:30am30 mins
Track 3: Recovery & Purification
Minimizing Resources in Developing Commercial Virus Filtration Processes with Planova™ BioEX
- Mike Bobbie - Senior Field Applications Specialist, Asahi Kasei Bioprocess America
11:00am - 11:30am30 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Building a robust Single-Use System Integrity (SUSI) assurance strategy to enhance product quality, patient and operator safety for both BDS Frozen & Liquid Shipping.
- Marc Hogreve - Principal Engineer Integrity Testing, Sartorius Stedim Biotech
- Elisabeth Vachette - Head of PM Bags/Mixing/Tanks, Sartorius Stedim Biotech
11:00am - 11:30am30 mins
Track 5: Intensified & Continuous Processing
Four Steps Toward Connected Biomanufacturing: A Pragmatic Approach to Start to Finish Processing
- Avril Vermunt - Connected Biomanufacturing Program Manager, GE
11:00am - 11:30am30 mins
Track 6: Cell & Gene Therapy Manufacturing
KUBio™ box – Filling the Current Gap in Viral Vector Manufacturing
- Ellen Johnson - Enterprise Solutions Technology Leader, GE Healthcare Life Sciences
11:00am - 11:30am30 mins
Track 7: Analytical & Quality
KUBio™ box – Filling the Current Gap in Viral Vector Manufacturing
- Ellen Johnson - Enterprise Solutions Technology Leader, GE Healthcare Life Sciences
11:00am - 11:30am30 mins
Track 8: Phase-Appropriate Process Development
Minimizing Resources in Developing Commercial Virus Filtration Processes with Planova™ BioEX
- Mike Bobbie - Senior Field Applications Specialist, Asahi Kasei Bioprocess America
11:30am - 12:00pm30 mins
Track 1: Cell Line Development & Engineering
Cell Line Development: A Case Study from Merck
- Bo Jiang - Principal Scientist, Merck
11:30am - 12:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Mechanistic investigation and characterization of product quality variability in a cell culture process
- Yelena Ilin - Scientist II, Upstream Process Science, Sanofi
11:30am - 12:00pm30 mins
Track 3: Recovery & Purification
Prediction of Monoclonal Antibodies with Drug-Like Biophysical Properties
- Yulei Zang, Ph.D. - Student, Chemical Engineering, University of Michigan
11:30am - 12:00pm30 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Sourcing Safe and Sustainable Single-Use Technology
- Mark Petrich - Director, Single-Use Systems Engineering, Merck & Co., Inc.
11:30am - 12:00pm30 mins
Track 5: Intensified & Continuous Processing
Implementing Continuous Processing for Novel Modalities from Small to Large Scale – Lessons Learned from Recent Progress
- Xuejun (Sherry) Gu, PhD - Vice President, CMC Management, WuXi Biologics
11:30am - 12:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Holistic Characterization of AAV Capsid Particle Using Advanced Analytical Tools
- Qin Zou, Ph.D. - Associate Research Fellow, Pfizer
11:30am - 12:00pm30 mins
Track 7: Analytical & Quality
Holistic Characterization of AAV Capsid Particle Using Advanced Analytical Tools
- Qin Zou, Ph.D. - Associate Research Fellow, Pfizer
11:30am - 12:00pm30 mins
Track 8: Phase-Appropriate Process Development
KEYNOTE ADDRESS: Progress Towards Achieving Single-Cycle Process Development
- Randal Bass, Ph.D. - Vice President of Process Design, Just - Evotec Biologics
11:30am - 12:30pm60 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
12:00pm - 12:30pm30 mins
Track 1: Cell Line Development & Engineering
A Multi-Omics Platform to Guide Rational Process Development for Recombinant Protein Expression
- Yizhou Zhou, PhD - Scientist II, Protein Cell Line Development, Biogen
12:00pm - 12:30pm30 mins
Track 2: Cell Culture & Upstream Processing
Optimizing Product Quality Attributes Using A Chemically Defined Media System
- David Lee - Research Associate III, Seattle Genetics
12:00pm - 12:30pm30 mins
Track 3: Recovery & Purification
Mechanistic Modeling of Filter Fouling during the Cell Culture Clarification Process
- Zizhao Liu, Ph.D. - Process Scientist, Process Sciences, Regeneron
12:00pm - 12:30pm30 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
A Playbook to Fully Utilise Closed Systems in Modern BioPharma Facilities
- Yongchun Zhang - Lead Engineer, SUT Platform, Bayer
12:00pm - 12:30pm30 mins
Track 5: Intensified & Continuous Processing
Developing a fully automated, flexible and integrated continuous downstream purification platform and demonstration of the production of three legacy batch processes
- Philip Probert, PhD - Senior Upstream Scientist, Centre for Process Innovation Limited
- Bethany Kerr - Scientist – Upstream Biologics, Centre for Process Innovation Limited
12:00pm - 12:30pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Commercial Manufacturing Requirements for Gene and Cell Therapies based on GMP
- Richard Denk - Senior Consultant Aseptic Processing & Containment., SKAN AG
12:00pm - 12:30pm30 mins
Track 7: Analytical & Quality
Commercial Manufacturing Requirements for Gene and Cell Therapies based on GMP
- Richard Denk - Senior Consultant Aseptic Processing & Containment., SKAN AG
12:00pm - 12:30pm30 mins
Track 8: Phase-Appropriate Process Development
KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies
- Shawn Lawrence, Ph.D. - Senior Director, Cell Culture Development, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc.
12:30pm - 1:40pm70 mins
Sponsored Luncheon Presentations
- Andreas Castan, PhD - Strategic Technology Partnerships Leader, GE Healthcare
- Jens Rupprecht - Project Manager, Sartorius Stedim Biotech
- Burkhard Joksch - Product Manager, Sartorius Stedim Biotech
- Melisa Carpio - Application Professional, Cell Culture Technologies, Sartorius Stedim NA
1:40pm - 1:45pm5 mins
Track 1: Cell Line Development & Engineering
Chairperson's Opening Remarks
1:40pm - 1:45pm5 mins
Track 2: Cell Culture & Upstream Processing
Chairperson's Opening Remarks
- Ali Mohamed - VP, CMC, Immatics, USA
1:40pm - 1:45pm5 mins
Track 3: Recovery & Purification
Chairperson's Opening Remarks
1:40pm - 1:45pm5 mins
Track 4: BioProcessing 4.0
Chairperson's Opening Remarks
1:40pm - 1:45pm5 mins
Track 5: Intensified & Continuous Processing
Chairperson's Opening Remarks
- Susan Dexter - Managing Director, Latham BioPharm Group
1:40pm - 1:45pm5 mins
Track 6: Cell & Gene Therapy Manufacturing
Chairperson's Opening Remarks
- Ali Mohamed - VP, CMC, Immatics, USA
1:40pm - 1:45pm5 mins
Track 7: Analytical & Quality
Chairperson's Opening Remarks
1:40pm - 1:45pm5 mins
Track 8: Phase-Appropriate Process Development
Chairperson’s Opening Remarks
1:40pm - 2:50pm70 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
1:45pm - 2:15pm30 mins
Track 1: Cell Line Development & Engineering
Role of Next Generation Sequencing in Clone Selection
- Marieke Zhao - Director, Cell Line Development, Mersana Therapeutics
1:45pm - 2:15pm30 mins
Track 2: Cell Culture & Upstream Processing
Closed, automated and controlled upstream processing for iPSC-derived cell therapies
- Mustafa Munye - Lead Scientist, Cell and Gene Therapy Catapult
1:45pm - 2:15pm30 mins
Track 3: Recovery & Purification
Challenges and Approaches to Virus Inactivation and Nanofiltration of Hydrophobic Monoclonal Antibodies
- Green Zhang, PhD - Associate Director, Large Molecule Purification, Incyte Corporation
1:45pm - 2:15pm30 mins
Track 4: BioProcessing 4.0
Manufacturing Facility Design and Operating Strategy at a Growing Biopharmaceutical Company
- Craig Curless - Senior Director of Manufacturing, Macrogenics, Inc.
1:45pm - 2:15pm30 mins
Track 5: Intensified & Continuous Processing
Opportunities and Challenges in Developing a Fully-Connected Continuous Manufacturing Process for Biologics
- Himanshu Gadgil, Ph.D - CSO and Whole-Time Director, Enzene Biosciences Ltd.
1:45pm - 2:15pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Closed, automated and controlled upstream processing for iPSC-derived cell therapies
- Mustafa Munye - Lead Scientist, Cell and Gene Therapy Catapult
1:45pm - 2:15pm30 mins
Track 7: Analytical & Quality
Setting Release Specifications to Ensure Product Quality
- Renuka Sivendran - Director, Analytical Development, Five Prime Therapeutics
1:45pm - 2:15pm30 mins
Track 8: Phase-Appropriate Process Development
Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?
- Susan Dana Jones, Ph.D. - Senior Vice President, Product Development, Harpoon Therapeutics
2:15pm - 2:45pm30 mins
Track 1: Cell Line Development & Engineering
Understanding Biopharmaceutical Manufacturing At Single Cell Resolution
- Colin Clarke, Ph.D. - Principal Investigator, National Institute for Bioprocessing
2:15pm - 2:45pm30 mins
Track 2: Cell Culture & Upstream Processing
Upstream Raw Material Variation Monitoring and Control Strategies
- David Kolwyck, M.S., MBA - Director, Manufacturing Sciences, Biogen
2:15pm - 2:30pm15 mins
Track 3: Recovery & Purification
European Continuous Downstream Processing Consortium (Located in Room 209/210)
- Alois Jungbauer - Professor and Chair, Laboratory of Protein Technology and Downstream Processing, Austrian Center of Biotechnology, Department of Biotechnology, University of Natural Resources and Life Sciences Vienna
2:15pm - 2:45pm30 mins
Track 4: BioProcessing 4.0
Organizing the Organizations of Single-Use Manufacturing Equipment
- James Dean Vogel - Founder and Director , The BioProcess Institute
2:15pm - 2:30pm15 mins
Track 5: Intensified & Continuous Processing
European Continuous Downstream Processing Consortium (Located in Room 209/210)
- Alois Jungbauer - Professor and Chair, Laboratory of Protein Technology and Downstream Processing, Austrian Center of Biotechnology, Department of Biotechnology, University of Natural Resources and Life Sciences Vienna
2:15pm - 2:45pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Upstream Raw Material Variation Monitoring and Control Strategies
- David Kolwyck, M.S., MBA - Director, Manufacturing Sciences, Biogen
2:15pm - 2:45pm30 mins
Track 7: Analytical & Quality
Traversing the pyramid: Data -> Information -> Knowledge -> Wisdom
- Richa Sarin - Scientist, Analytical Development, Biogen
2:15pm - 2:45pm30 mins
Track 8: Phase-Appropriate Process Development
Partnering with Research to Accelerate CMC Timelines
- Dot Reilly, MS - Senior Technical Development Leader, Genentech
2:30pm - 2:45pm15 mins
Track 3: Recovery & Purification
Update from Continuous Processing BPOG Workstream (Located in Room 209/210)
- Kristina Pleitt - Senior Scientist, Downstream Process Development, Patheon
2:30pm - 2:45pm15 mins
Track 5: Intensified & Continuous Processing
Update from Continuous Processing BPOG Workstream (Located in Room 209/210)
- Kristina Pleitt - Senior Scientist, Downstream Process Development, Patheon
2:45pm - 2:50pm5 mins
Track 1: Cell Line Development & Engineering
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 2: Cell Culture & Upstream Processing
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 3: Recovery & Purification
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 4: BioProcessing 4.0
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 5: Intensified & Continuous Processing
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 6: Cell & Gene Therapy Manufacturing
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 7: Analytical & Quality
Transition to Technology Workshops
2:45pm - 2:50pm5 mins
Track 8: Phase-Appropriate Process Development
Transition to Technology Workshops
2:50pm - 3:20pm30 mins
Technology Workshop 1
CHOgro High Yield Expression System - A New and Improved System for Transient Transfection of Suspension CHO Cells to Achieve Higher Protein Titers Faster
- Miguel Dominguez - Director, Sales & Support, Mirus Bio LLC
2:50pm - 3:20pm30 mins
Technology Workshop 2
Media Development for Producing Antibodies with Specific Quality Attributes
- Thomas Fletcher - Scientific Director, Fujifilm Irvine Scientific
2:50pm - 3:20pm30 mins
Technology Workshop 3
CaptureSelect™ CH1-XL as an Alternative to Protein A for Capture of Bispecific Antibodies
- Brett Jorgensen - Director, Teneobio, Inc.
2:50pm - 3:20pm30 mins
Technology Workshop 4
Leap-In Transposase® Mediated Stable Cell Line Development: More, Better, Faster
2:50pm - 3:20pm30 mins
Technology Workshop 5
Enabling Successful Technology Transfers: A CDMO Perspective
- Madhav Paranandi - Sr. Director, MSAT, Kemwell Biopharm
2:50pm - 3:20pm30 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
3:20pm - 4:00pm40 mins
Networking Refreshment Break in Exhibit & Poster Hall
4:00pm - 4:30pm30 mins
Track 1: Cell Line Development & Engineering
CHO Cell Engineering Targets: Reducing Cell-Cell Aggregate Formation and Insulin Degradation in Culture Media, Two Case Studies
- Shahram Misaghi, PhD - Senior Scientist, Genentech, Inc
4:00pm - 4:30pm30 mins
Track 2: Cell Culture & Upstream Processing
Development and Optimisation of a Scalable Suspension Process for AAV Production
- Bethany Kerr - Scientist, CPI
4:00pm - 4:30pm30 mins
Track 3: Recovery & Purification
Integration of Analytical with Downstream Processing to Enable Continuous Processing
- Amos Lu, Ph.D. - Postdoctoral Associate, Department of Chemical Engineering, MIT
4:00pm - 4:30pm30 mins
Track 4: BioProcessing 4.0
Leveraging Smart and Digital Technologies in Bioprocessing
- Samet Yildirim - Technology Innovation Manager, Boehringer Ingelheim Fremont, Inc.
4:00pm - 4:30pm30 mins
Track 5: Intensified & Continuous Processing
Integration of Analytical with Downstream Processing to Enable Continuous Processing
- Amos Lu, Ph.D. - Postdoctoral Associate, Department of Chemical Engineering, MIT
4:00pm - 4:30pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Manufacturing Process & Product Development Efforts for Producing Capricor’s Cardiosphere Derived Cells and Exosomes
- Luis Rodriguez-Borlado - Vice President of Regenerative Therapies, Capricor
4:00pm - 4:30pm30 mins
Track 7: Analytical & Quality
NMR as a Quantitative Universal Proton Detector in Biopharmaceutical Manufacturing and R&D: Applications to Process Component and Trace Impurity Analysis in Complex Matrices
- Gennady Khirich, PhD - Scientist, Genentech
4:00pm - 4:30pm30 mins
Track 8: Phase-Appropriate Process Development
Achieve Integrated Process Development and Manufacturing Through Outsourcing
- Ying Zhu, Ph.D. - Head of CMC, Ankasa Regenerative Therapeutics, Inc.
4:00pm - 5:30pm90 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
- James Dean Vogel - Founder and Director , The BioProcess Institute
4:30pm - 5:00pm30 mins
Track 1: Cell Line Development & Engineering
Influencing Protein Production Utilizing Metabolomics and Reducing Bottlenecks
- Nathan Lewis, PhD - Associate Professor, Department of Pediatrics, University of California, San Diego
4:30pm - 5:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Applications Of Next-Generation Single-Use Bioreactor
- Marshall Bowden III - Engineer, Upstream and Pilot Development, Biogen
4:30pm - 5:00pm30 mins
Track 3: Recovery & Purification
Continuous and Integrated Bioprocess Development for Novel Modalities
- Ricardo Silva - Downstream Process Development , iBET - Instituto de Biologia Experimental e Tecnológica, Portugal
4:30pm - 5:00pm30 mins
Track 4: BioProcessing 4.0
What Does Digitalization Really Mean to DS Manufacturing? A Case Study
- Bonnie Shum - Senior Engineer, Genentech
4:30pm - 5:00pm30 mins
Track 5: Intensified & Continuous Processing
Continuous and Integrated Bioprocess Development for Novel Modalities
- Ricardo Silva - Downstream Process Development , iBET - Instituto de Biologia Experimental e Tecnológica, Portugal
4:30pm - 5:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Process Validation and CPV for Cell and Gene Therapy
- Vijay Patel - Process Validation, bluebird bio
4:30pm - 5:00pm30 mins
Track 7: Analytical & Quality
Application of a Multi-Attribute Method (MAM) to Support Process Development of an Antibody Drug Conjugate (ADC)
- Joshua Woods - Principal Scientist, Analytical Research and Development, Pfizer
4:30pm - 5:00pm30 mins
Track 8: Phase-Appropriate Process Development
Speed to Clinic: Vector Supply Strategy for Early-Stage Cellular Therapy
- Sarah Lee - Associate Director, Early stage vector CMC lead, Juno Therapeutics
5:00pm - 5:30pm30 mins
Track 1: Cell Line Development & Engineering
Improvement of therapeutic protein production and quality: Coping with ER stress
- Tae Kwang Ha - Specialist, Novo Nordisk Foundation Center for Biosustainability, DTU
5:00pm - 5:30pm30 mins
Track 2: Cell Culture & Upstream Processing
Raman Spectroscopy for Process Monitoring and Lessons Learned in Development & Manufacturing
- Nobel Vale - Research Scientist II, Bristol-Myers Squibb
5:00pm - 5:30pm30 mins
Track 3: Recovery & Purification
Case Study: Robust Continuous/Integrated Process Enabled by Tankless Mixing
- Joelle Khouri - Scientist I, Protein Science, Process Science, Boehringer Ingelheim
5:00pm - 5:30pm30 mins
Track 4: BioProcessing 4.0
Accelerating Pipeline Progression: Challenges and Opportunities of Bioprocessing 4.0 in Process Development
- Christoph Pistek - Global Head, Technology Sciences, Takeda - R&D
5:00pm - 5:30pm30 mins
Track 5: Intensified & Continuous Processing
Case Study: Robust Continuous/Integrated Process Enabled by Tankless Mixing
- Joelle Khouri - Scientist I, Protein Science, Process Science, Boehringer Ingelheim
5:00pm - 5:30pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Implementation of “off the shelf” Closed Systems fit for every purpose
- Ali Mohamed - VP, CMC, Immatics, USA
5:00pm - 5:30pm30 mins
Track 7: Analytical & Quality
Implementing MAM Into A QC Environment
- Ting Song - QC Specialist, Amgen
5:00pm - 5:30pm30 mins
Track 8: Phase-Appropriate Process Development
Full Scale Production of a Therapeutic Neurotoxic Protein by Cell-Free Expression
- Philip Probert, PhD - Senior Upstream Scientist, Centre for Process Innovation Limited
5:30pm - 6:30pm60 mins
Cocktail Reception in Exhibit & Poster Hall
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