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Delivered as a Hybrid Event
September 27-30, 2022Boston Convention and Exhibition Centerkeyboard_arrow_right
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Day Four - EST/EDT (Eastern Daylight, GMT-4)
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Day Four - EST/EDT (Eastern Daylight, GMT-4)
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8:00am - 8:25am25 mins
Coffee and Registration
8:25am - 8:30am5 mins
Cell Culture & Upstream Processing
Chairperson's Opening Remarks
8:25am - 8:30am5 mins
Recovery & Purification
Chairperson's Opening Remarks
8:25am - 8:30am5 mins
Manufacturing Strategy & Bioprocessing 4.0
Chairperson's Opening Remarks
8:25am - 8:30am5 mins
Intensified & Continuous Processing
Chairperson's Remarks
8:25am - 10:00am95 mins
"SBR -1 Workshop (developed and run by Jeff Baker)"
It has been well posited that adults learn best through memorable experiences. Effective blended learning programs provide relevant experiences in low risk environments and can be used to anticipate and frame learning needs rather than scavenging learning opportunities from unplanned events. This course is intended as an example of using interactive simulation gaming as a tool for blended learning, specifically introducing participants to the routine and unanticipated elements of operating a biopharmaceutical manufacturing facility. In this session we will touch on elements of capacity and throughput management, statistical process control, quality culture, assignment of roles and responsibilities, and examples of the cost vs value conundrum confronted by manufacturing site governance. Attendees will be participating in a Learning Laboratory experience that is not compatible with coming and going during the session, doing email on your phone, or bailing out when an in control and capable process with fully gaussian outputs, little if any special cause variability, and a very accommodating and flexible management team suddenly goes awry!
- Jeffrey Baker - Senior Fellow, NIIMBL, Senior Strategy Advisor of CBI, MIT, (former Deputy Director, Office of Biotechnology Products, CDER, US FDA)
8:25am - 8:30am5 mins
Cell and Gene Therapy - Partnering Track
Chairperson's Opening Remarks
8:25am - 8:30am5 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Chairperson's Opening Remarks
8:25am - 10:00am95 mins
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
8:30am - 9:00am30 mins
Cell Culture & Upstream Processing
Controlling Product Quality Using In-Process Control Strategies
- Cindy Chelius, Ph.D. - Senior Scientist, Upstream Bioprocess Development, Global Product Development & Supply, Bristol Myers Squibb
8:30am - 9:00am30 mins
Recovery & Purification
Evaluation of the CARR® Unifuge in Establishing a Robust Cell Expansion Platform
- Kanaka Bhere - Senior Scientist, Merck
8:30am - 9:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
How AI, ML and continuous manufacturing technologies can drive flexible biomanufacturing: the J.POD® facility example
- Randal Bass, Ph.D. - Senior Vice President, Biotherapeutic Process & Product Design, Just - Evotec Biologics
8:30am - 9:00am30 mins
Intensified & Continuous Processing
Improving Perfusion Productivity Using a Toolbox of Cell Line Characterization, Media Design and High Throughput Scale-Down Models
- Kurtis Denny - Engineer I, Cell Culture Development, Biogen
8:30am - 8:50am20 mins
Cell and Gene Therapy - Partnering Track
Navigating the Global Regulatory Landscape for Cell and Gene Therapies to Accelerate Worldwide Product Launches
8:30am - 9:00am30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Opening Remarks and New Frontiers in Manufacturing Biofabrication with ARMI
- Mary Clare McCorry - Director, Technology and Process Development, Advanced Regenerative Manufacturing Institute (ARMI)
8:50am - 9:20am30 mins
Cell and Gene Therapy - Partnering Track
How Non-EEA ATMP Pharma/Biotech Can Leverage Compliance to the New Revision of EU Annex 1 to Achieve Cross Border Manufacturing Compliance with a Simple Approach
- Francesco Cicirello - Director, Quality Assurance, Evelo Biosciences
9:00am - 9:30am30 mins
Cell Culture & Upstream Processing
Defining Upstream Process Design Space Using QbD Methodology
- Santosh Pande, Ph.D. - Senior Scientist I, Process Sciences, BioMarin
9:00am - 9:30am30 mins
Recovery & Purification
Next Generation Depth Filter for Harvest
- Sanjay Nilapwar, Ph.D. - Principal Scientist I, Purification Development, BioProcess Development, Abbvie
9:00am - 9:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Modelling Case Study
- Christian Airiau, Ph.D - Global Head, Data Sciences - Biologics Development, Sanofi
9:00am - 9:30am30 mins
Intensified & Continuous Processing
Using Computational Fluid Dynamics Modeling and Subvisible Particles Analysis to Evaluate the Performance of Hollow Fiber Membrane Filters in Tangential Flow Filtration for N-1 Perfusion Cell Culture
- Caitlin Kurtz - Engineer I, Biogen
9:00am - 9:30am30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Raw Materials/ Starting Materials
- Mike Morgan - Vice President of Sales, Nucleus Biologics
9:20am - 10:00am40 mins
Cell and Gene Therapy - Partnering Track
Panel Discussion: Investment View on Innovation in Cell & Gene Therapy: Trends, Technologies, and Early-Stage Success
- Shaan Gandhi - Director, Northpond Ventures
- Bryan Poltilove - Operating Partner, BroadOak Capital Partners
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
Scientific Track Presentation
9:30am - 10:00am30 mins
Recovery & Purification
Scientific Track Presentation
9:30am - 10:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
9:30am - 10:00am30 mins
Intensified & Continuous Processing
Scientific Track Presentation
9:30am - 10:00am30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Cell Culture and Expansion
10:00am - 11:00am60 mins
Networking Refreshment Break in the Exhibit & Exhibit Hall
11:00am - 11:30am30 mins
Cell Culture & Upstream Processing
Enabling Robust Biomanufacturing Through Systematic Understanding of Single-Use Systems and Stringent Process and Raw Material Controls
- Jun Tian - Executive Director, Biologics Process Development, WuXi Biologics
11:00am - 11:30am30 mins
Recovery & Purification
Rightsizing Continuous Processing for ADCs
- James Patch, Ph.D. - Associate Director, Seagen
11:00am - 11:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Opportunities and Challenges of Process Analytical Technology (PAT) in Bioprocessing 4.0
- Dhanuka Wasalathanthri, PhD - Senior Principal Scientist, Bristol Myers Squibb
11:00am - 11:30am30 mins
Intensified & Continuous Processing
Defining a Next-Generation Platform Process: Production-Stage Intensification with Higher Titer and Sustained Product Quality
- Jake Kim - Scientist I/Project Leader, Upstream Process Development, KBI Biopharma
11:00am - 12:00pm60 mins
"SBR -1 Workshop (developed and run by Jeff Baker)"
SBR-1 Workshop Continued
- Jeffrey Baker - Senior Fellow, NIIMBL, Senior Strategy Advisor of CBI, MIT, (former Deputy Director, Office of Biotechnology Products, CDER, US FDA)
11:00am - 12:00pm60 mins
"Inbound Supply Chain and Manufacturing Strategy (co-developed with BioPhorum)"
Session
11:00am - 11:45am45 mins
Cell and Gene Therapy - Partnering Track
Panel Discussion: Market Access, Pricing and Reimbursement Strategies for Cell and Gene Therapies
- Kristin Wolff - Vice President, Access, Value, and Evidence Strategy (AVES), bluebird bio
- A Representative from Bayer - ., Bayer
11:00am - 11:30am30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Cell Harvest or Label-free Cell Selection and Purification
11:00am - 12:30pm90 mins
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
11:30am - 12:00pm30 mins
Cell Culture & Upstream Processing
Unique Process Scale-Up Challenges in a Stainless Steel Bioreactor: A Case Study
- Pritam Sinha Roy - Scientist I, Upstream Process Development, Biologics CMC, Teva Pharmaceuticals
11:30am - 12:00pm30 mins
Recovery & Purification
Chromatographic Method Development for Enrichment of Full Capsids
- Paul Greback-Clarke - AAV Process Development Scientist, AskBio
11:30am - 12:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Think Big, Start Small – Capability Implementation on the Path to Smart Manufacturing and Intelligent Development within Industry 4.0
- Daniel Hill - Digital Delivery Leader, Pharmaceutical Operations & Technology, Biogen
11:30am - 12:00pm30 mins
Intensified & Continuous Processing
Continuous Processing for Reducing Costs in Production of Recombinant Proteins
- Scott Wheelwright, PhD - Chief Operating Officer, BioInno Bioscience Co., Ltd.
11:30am - 12:00pm30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Sensors
- Naresh Menon - Founder/CEO, ChromoLogic LLC
11:45am - 12:15pm30 mins
Cell and Gene Therapy - Partnering Track
Panel Discussion: Accelerating the Stand-up of a New Cell Therapy Manufacturing Site
- Gwen Hall - Customer Executive, Point B
- Laura McIntyre - Solutions Director, Operational Processes Improvement, Point B
- Jen Newman - Senior Managing Consultant, Life Science, Point B
- Mark Jackson - Managing Principal , Real Estate & Facilities, Point B
12:00pm - 12:30pm30 mins
Cell Culture & Upstream Processing
Scientific Track Presentation
12:00pm - 12:30pm30 mins
Recovery & Purification
Scientific Track Presentation
12:00pm - 12:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
12:00pm - 12:30pm30 mins
Intensified & Continuous Processing
Scientific Track Presentation
12:00pm - 12:30pm30 mins
"Inbound Supply Chain and Manufacturing Strategy (co-developed with BioPhorum)"
Scientific Track Presentation
12:00pm - 12:30pm30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Scaffold Fabrication
- Sharon Ballard - CEO, NuShores Biosciences, LLC
12:30pm - 1:55pm85 mins
Networking Luncheon in the Exhibit & Poster Hall
1:55pm - 2:00pm5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
1:55pm - 2:00pm5 mins
Recovery & Purification
Chairperson's Remarks
1:55pm - 2:00pm5 mins
Manufacturing Strategy & Bioprocessing 4.0
Chairperson's Remarks
1:55pm - 2:00pm5 mins
Intensified & Continuous Processing
Chairperson's Remarks
1:55pm - 2:00pm5 mins
Cell and Gene Therapy - Partnering Track
Chairperson's Remarks
1:55pm - 2:00pm5 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Chairperson's Remarks
1:55pm - 2:00pm5 mins
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
Chairperson's Remarks
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
Engineering CHO Cells to Disrupt Endogenous Retrovirus Production: Towards a New Platform for Manufacturing Enveloped VLPs and Other Biologics
- Matthew Stuible, Ph.D. - Research Officer, Mammalian Cell Expression Section, Team Leader, Cell Engineering, National Research Council Canada
2:00pm - 2:30pm30 mins
Recovery & Purification
Development and Optimization of a Complete Bioprocess for MSC-EV Production and Purification
- Elie Zakhem, Ph.D. - Manager, Process Development, RoosterBio, Inc.
2:00pm - 2:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Data Science for CMC
- Yingying Zheng - Associate Director, Data Science, Gilead
2:00pm - 2:30pm30 mins
Intensified & Continuous Processing
Perspectives from NIIMBL’s Process Intensification Workstream - Innovations Needed to Enable Continuous Processing
- John Erickson - Acting Chief Technology Officer, NIIMBL
2:00pm - 2:45pm45 mins
Cell and Gene Therapy - Partnering Track
Panel Discussion: Relationship Management - Best Practises for Working with CDMO and Suppliers
- Kumar Dhanasekharan - Senior Vice President of Technical Operations, Renovacor
- Daniel Harkins - Associate Director, External Manufacturing and Supply, Cell Therapies, Pharmaceutical Sciences, Takeda
- Shenjiang (Shawn) Liu - President & CEO, Avirmax Inc.
2:00pm - 2:30pm30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Obtaining Commercial Approval for a Tissue Based Regenerative Medicine Product - A CMC Perspective
- Larry Weiner - VP of Pharmaceutical Development & Manufacturing, Enzyvant Therapeutics
2:00pm - 5:00pm180 mins
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
Hands-On Interactive Training Course: Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
Progress with Exosomes
- Scott Estes, PhD - Vice President, Codiak Biosciences
2:30pm - 3:00pm30 mins
Recovery & Purification
NC-VVIRAL: a Novel Bioprocess Toolbox for the Affinity Purification of Therapeutic Viruses
- Stefano Menegatti - Associate Professor, North Carolina State University
2:30pm - 3:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Advanced Manufacturing of Biotherapeutics: Modeling, Data Analytics, and Control
- Richard Braatz, PhD - Edwin R. Gilliland Professor, Massachusetts Institute of Technology
2:30pm - 3:00pm30 mins
Intensified & Continuous Processing
Flexible Process Intensification & Modification of Downstream mAb Processes for Increased Productivity
- Debola Banerjee - Associate Director, Protein Science, Boehringer Ingelheim
2:30pm - 3:00pm30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Tissue Maturation and Bioreactor Culture
2:45pm - 3:30pm45 mins
Cell and Gene Therapy - Partnering Track
Panel Discussion: Lessons Learnt from COVID-19 Pandemic to Enhance Security of Supply Chain
- Shashi Murthy - Founder & Chief Technology Officer, Flaskworks
3:00pm - 3:30pm30 mins
Cell Culture & Upstream Processing
Dream Big, Start Small: Improving Recombinant Adeno-Associated Virus Production Through Plasmid Design and Host Cell Line Optimization
- Yizhou Zhou, PhD - Scientist II, Protein cell line development, Biogen
3:00pm - 3:30pm30 mins
Recovery & Purification
Downstream Process of Lentiviral Vector and Technology Transfer to Manufacturing
- Sofia Moreira - Student, Downstream Processing Lab, iBET
3:00pm - 3:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Topic TBC
- Neeraj Agrawal - Scientist, Group Lead, Amgen
3:00pm - 3:30pm30 mins
Intensified & Continuous Processing
Continuous Precipitation for Antibody Purification
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair and Professor of Chemical Engineering, The Pennsylvania State University
3:00pm - 3:30pm30 mins
New Frontiers for Cell and Tissue Manufacturing: In Collaboration with ARMI
Cultured Meat and Alternative TEMPs
- Brandon Chen - Chief Technology Officer, Finless Foods
5:00pm - 5:05pm5 mins
End of Conference 2022
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