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DAY THREE - PST/PDT (Pacific Daylight, GMT-7)
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DAY THREE - PST/PDT (Pacific Daylight, GMT-7)
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10:00am - 10:05am5 mins
Conference Opening and Welcome
10:05am - 11:00am55 mins
Plenary Session
Fireside Chat with Novartis Gene Therapies - Scaling of a Gene Therapy Manufacturing Process: From Clinical to Commercial
- Robert Hodge - VP, Technical Development, Novartis Gene Therapies, USA
- Anthony Davies, Ph.D. - Founder & CEO, Dark Horse Consulting
11:05am - 11:25am20 mins
Track 1: Cell Line Development & Engineering
KEYNOTE: Comparison of CHO and mastocytoma cells for production of a bioengineered heparin
- Susan Sharfstein, PhD - Professor of Nanobioscience, SUNY Polytechnic Institute
11:05am - 11:25am20 mins
Track 2: Cell Culture
Challenges and Solutions in Upstream Production of Conditionally Active Therapeutic Products
- Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
11:05am - 11:25am20 mins
Track 3: Recovery & Purification
Advancement of Integrated Continuous Bioprocessing with Next Generation Continuous Countercurrent Tangential Chromatography (CCTC)
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair and Professor of Chemical Engineering, The Pennsylvania State University
11:05am - 11:25am20 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Best Practices for Streamlining Technology Transfer and Manufacturing for Early Stage Clinical Products
- Alpana Naresh, Ph.D. - Director, CMC Operations, Harpoon Therapeutics Inc.
11:05am - 11:25am20 mins
Track 5: Intensified & Continuous Processing
Advancement of Integrated Continuous Bioprocessing with Next Generation Continuous Countercurrent Tangential Chromatography (CCTC)
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair and Professor of Chemical Engineering, The Pennsylvania State University
11:05am - 11:25am20 mins
Track 6: Cell & Gene Therapies
Development and Optimisation of Scalable Manufacturing Processes For AAV
- Bethany Kerr - Team Leader, Upstream Development, Centre for Process Innovation Limited
11:05am - 11:15am10 mins
Live Labs
UP.SIGHT: Changing the World of Single Cell Technologies
- Fabian Stumpf - CMO, Cytena (A Cellink Company)
11:15am - 11:25am10 mins
Live Labs
Get More Molecules to the Clinic Faster with Automated OptoTM Cell Line Development by Berkeley Lights
- Renee Tobias - Director CLD Product Management, Berkeley Lights
11:30am - 11:50am20 mins
Track 1: Cell Line Development & Engineering
Advancing the rAAV Producer Cell Line Platform with Process Improvements to High-Throughput Screening and Automation
- Jennifer Lin - Scientist II, Gene Therapy, Biogen
11:30am - 11:50am20 mins
Track 2: Cell Culture
Hydrocyclones as a cell retention device for an N-1 perfusion linked to a production CSTR
- Anita Kundu - Scientist, Pfizer
11:30am - 11:50am20 mins
Track 3: Recovery & Purification
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, CPI Biologics
11:30am - 11:50am20 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Accelerated Tech Transfer from Development to Manufacturing for a COVID-19 Program
- Andrew Kim - Associate Director, Downstream MSAT, Samsung Biologics
11:30am - 11:50am20 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, CPI Biologics
11:30am - 11:50am20 mins
Track 6: Cell & Gene Therapies
Development of a next generation AAV manufacturing platform
- Michael Delahaye - Head of Viral Vector Industralisation, Cell & Gene Therapy Catapult
11:55am - 12:15pm20 mins
Track 1: Cell Line Development & Engineering
High-Throughput Image Cytometry for Cellular Analysis and Optimized Workflows
- Henry Qazi, PhD - Field Applications Scientist, Nexcelom Bioscience
11:55am - 12:15pm20 mins
Track 2: Cell Culture
Ready for Biopharma 4.0? Accelerating your cell culture development with biopharma lifecycle management
- Unjulie Bhanot - Solution Owner, IDBS
11:55am - 12:15pm20 mins
Track 3: Recovery & Purification
Tools to Enable Smart Data Management and Advanced Analytics in Biopharmaceutical Manufacturing
- Hemant Garg - Product Manager Analytics, MilliporeSigma
11:55am - 12:15pm20 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Enabling Successful Technology Transfers: A CDMO Perspective
- Madhav Paranandi - Sr. Director, Process Development & MSAT, Kemwell Biopharm
11:55am - 12:15pm20 mins
Track 5: Intensified & Continuous Processing
Tools to Enable Smart Data Management and Advanced Analytics in Biopharmaceutical Manufacturing
- Hemant Garg - Product Manager Analytics, MilliporeSigma
11:55am - 12:15pm20 mins
Track 6: Cell & Gene Therapies
Quantify CQAs of gene vectors by SEC-MALS and FFF-MALS
- Michelle Chen, Ph.D. - Vice President of Analytical Services, Wyatt Technology
12:20pm - 12:40pm20 mins
Track 1: Cell Line Development & Engineering
Sponsored Luncheon Presentations
12:20pm - 12:40pm20 mins
Track 2: Cell Culture
Sponsored Luncheon Presentations
12:20pm - 12:40pm20 mins
Track 3: Recovery & Purification
Sponsored Luncheon Presentations
12:20pm - 12:40pm20 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Sponsored Luncheon Presentations
12:20pm - 12:40pm20 mins
Track 5: Intensified & Continuous Processing
Sponsored Luncheon Presentations
12:20pm - 12:40pm20 mins
Track 6: Cell & Gene Therapies
Sponsored Luncheon Presentations
12:45pm - 1:10pm25 mins
Track 1: Cell Line Development & Engineering
Roundtable Discussions
12:45pm - 1:10pm25 mins
Track 2: Cell Culture
Roundtable Discussions
12:45pm - 1:10pm25 mins
Track 3: Recovery & Purification
Roundtable Discussions
12:45pm - 1:10pm25 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Roundtable Discussions
12:45pm - 1:10pm25 mins
Track 5: Intensified & Continuous Processing
Roundtable Discussions
12:45pm - 1:10pm25 mins
Track 6: Cell & Gene Therapies
Roundtable Discussions
1:15pm - 1:35pm20 mins
Track 1: Cell Line Development & Engineering
Cell line development platform for asymmetric bispecific antibodies
- YenRu Pan, Ph.D. - Senior Research Scientist I, Process Development, Gilead Sciences
1:15pm - 1:35pm20 mins
Track 2: Cell Culture
SUT innovations – Bridging the Next Generation of Enabling Operations
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
1:15pm - 1:35pm20 mins
Track 3: Recovery & Purification
SUT innovations – Bridging the Next Generation of Enabling Operations
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
1:15pm - 1:35pm20 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Viral Safety for Gene Therapy Vector Production
- Shengjiang "Shawn" Liu, Ph.D. - President and CEO, Avirmax Inc
1:15pm - 1:35pm20 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.
1:15pm - 1:35pm20 mins
Track 6: Cell & Gene Therapies
Viral Safety for Gene Therapy Vector Production
- Shengjiang "Shawn" Liu, Ph.D. - President and CEO, Avirmax Inc
1:15pm - 2:35pm80 mins
Live Labs
5-10 minute live demos and presentations focusing on the most innovative technologies, equipment and services to hit today's biopharmaceutical market
1:40pm - 2:00pm20 mins
Track 1: Cell Line Development & Engineering
Identification and Remediation of Expression Liabilities in an Asymmetric Four-Chain Bispecific Molecule
- Cai Guo, PhD - Scientist, Cell Line Development, Amgen
1:40pm - 2:00pm20 mins
Track 2: Cell Culture
3D imaging for structural evaluation of bioseparations materials to inform design decisions
- Thomas Johnson - Ph.D., Post-Doctoral Research Associate, Biochemical Engineering, UCL
1:40pm - 2:00pm20 mins
Track 3: Recovery & Purification
3D imaging for structural evaluation of bioseparations materials to inform design decisions
- Thomas Johnson - Ph.D., Post-Doctoral Research Associate, Biochemical Engineering, UCL
1:40pm - 2:00pm20 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
ddPCR for Genomic Titre Assays & Vector Integrity
- David Dobnik - Senior Research Associate, National Institute of Biology, Slovenia
1:40pm - 2:00pm20 mins
Track 5: Intensified & Continuous Processing
How continuous bioprocessing can transform future of biomanufacturing to provide speed, affordability and high quality medicines to patients in need?
- Christopher Hwang, Ph.D. - Chief Technology Officer, Transcenta Holdings
1:40pm - 2:00pm20 mins
Track 6: Cell & Gene Therapies
ddPCR for Genomic Titre Assays & Vector Integrity
- David Dobnik - Senior Research Associate, National Institute of Biology, Slovenia
2:05pm - 2:25pm20 mins
Track 1: Cell Line Development & Engineering
What to consider in selecting the best cell line to accelerate the timeline to IND
- Seahee Kim - Head of Cell Line Development, Samsung Biologics
2:05pm - 2:35pm30 mins
Track 2: Cell Culture
PANEL: Integrating New Technologies and Processes within Established Workflows and Facilities
- Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
2:05pm - 2:35pm30 mins
Track 3: Recovery & Purification
PANEL: Integrating New Technologies and Processes within Established Workflows and Facilities
- Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
2:05pm - 2:35pm30 mins
Track 4: Manufacturing Strategy & Bioprocessing 4.0
Panel: Cell & Gene Therapy Analytics
- Jeffrey Hung - Chief Commercial Officer, Vigene Biosciences, Inc., USA
2:05pm - 2:35pm30 mins
Track 5: Intensified & Continuous Processing
Panel: Integrating New Technologies and Processes within Established Workflows and Facilities
- Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
- Adam Goldstein - Senior Director, R+D SUT, Thermo Fisher Scientific
2:05pm - 2:35pm30 mins
Track 6: Cell & Gene Therapies
Panel: Cell & Gene Therapy Analytics
- Jeffrey Hung - Chief Commercial Officer, Vigene Biosciences, Inc., USA
2:30pm - 3:00pm30 mins
Track 1: Cell Line Development & Engineering
PANEL: Speeding Up Cell Line Development via Workflow Optimisation Techniques and Technologies
- Cai Guo, PhD - Scientist, Cell Line Development, Amgen
- YenRu Pan, Ph.D. - Senior Research Scientist I, Process Development, Gilead Sciences
- Yashas Rajendra - Senior Scientist, Denali Therapeutics
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