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Pre Conference Workshops - PT (Pacific Time, GMT-08:00)
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Pre Conference Workshops - PT (Pacific Time, GMT-08:00)
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8:00am - 8:55am
Coffee and Registration
Showing 3 of 3 Streams
RNA-based Process Development & Manufacturing
Intensifed and Continuous Manufacturing
CDMO Oversight in Biomanufacturing - Thomas Chattaway
8:55am - 9:00am
Chairperson's Opening Remarks
- Aravindan Rajendran - Associate Research Fellow, Pfizer
9:00am - 9:30am
Towards Developing mRNA Platform Process: Lessons from Other Modalities
- John Li - Director - RNA Drug Substance, Capstan Therapeutics
9:30am - 10:00am
Continuous Manufacturing for mRNA-based Therapeutics and Vaccines
- Zoltán Kis - Senior Lecturer (Associate Professor), Department of Chemical & Biological Engineering, University of Sheffield
10:00am - 10:30am
Immunostimulatory Nucleic Acid Nanoparticles for Biomedical Applications
- Kirill Afonin, PhD - Vice President | Professor, International Society of RNA Nanotechnology and Nanomedicine (ISRNN) | UNC Charlotte
10:30am - 11:00am
Please move to another track
8:55am - 9:00am
Chairperson's Opening Remarks
- Ken Lee - Director, Bioprocess Technologies and Engineering, BioPharmaceuticals Development, R&D, AstraZeneca
9:00am - 9:30am
Metabolomics Improving Continuous Titers
- Christina Fiaschetti - Associate Director of Upstream Process Development, BioFactura
9:30am - 10:00am
Process Control of Continuous Bioprocesses
- Anurag Rathore, Ph.D. - Professor, Indian Institute of Technology
10:00am - 10:30am
From Traditional to Continuous: Advancing Manufacturing through Process Improvements and Automation
- Flaka Radoniqi - Process Development Scientist, Amgen
10:30am - 11:00am
Opportunities and Challenges in Developing a Fully Connected Continuous Manufacturing Process for Biologics
- Shilpa Gadgil - AVP, Head of CDMO development, Head of Advanced Analytical Techniques, Enzene Biosciences Ltd.
8:55am - 10:55am
CDMO Oversight in Biomanufacturing
•Introduction to CDMO Management with 3 sessions throughout the day.
•CDMOs in our industry
•Main difficulties to consider
•Session 1: Selecting and contracting a CDMO
•CDMO selection model
•Different contractual documents
•Batch pricing
- Thomas Chattaway - Senior Life Science Consultant, Independent
11:00am - 11:30am
Morning Coffee Break
Showing 4 of 4 Streams
Next Generation Manufacturing for Emerging CGTs
RNA-based Process Development & Manufacturing
Intensifed and Continuous Manufacturing
CDMO Oversight in Biomanufacturing - Thomas Chattaway
11:30am - 11:35am
Chairperson's Opening Remarks
- Amish Patel - SVP, Technical Activity Committee at NIIMBL, Calidi Biotherapeutics
11:35am - 12:00pm
COGS Under $15K for Cell Therapies via Improved Expansion
- Jeff Liter - CEO & Co-Founder, Luminary Therapeutics
12:00pm - 12:30pm
Integration of Automation and Closed Processing in Cell Therapy
- Semsi Ensari - Senior Director, Process Development, Kite Pharma, a Gilead Company
12:30pm - 1:00pm
Allogeneic Cell Therapies Case Study: Overcoming Manufacturing Hurdles for “Off the Shelf” Therapies
- Max Sidorov - Sr. Manager, Process Development, Caribou Biosciences
11:30am - 12:00pm
Development of Analytical Methods for Endless RNA™
- Francis Poulin, Ph.D. - Vice President, Analytical Sciences, Sail Biomedicines
12:00pm - 12:30pm
Navigating the Complexity of mRNA-LNP Manufacturing
- Padmadhar Madupu, MS - Director, Manufacturing, Omega Therapeutics
12:30pm - 1:00pm
Please move to another track
11:30am - 12:00pm
Impact of Shear Stress on Cell Culture during an N-1 Perfusion Process
- Neal Stroud - Principal Biologist, Bioproduct Research and Development, Eli Lilly and Company
12:00pm - 12:30pm
Biomanufacturing Readiness Levels (BRL): Navigating Hurdles & Advancing Technology Adoption in Biopharmaceuticals
- Sandeep Kedia - Senior Technology Fellow, The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
12:30pm - 1:00pm
Please move to another track
11:30am - 1:00pm
CDMO Oversight in Biomanufacturing
Session 2: Project Work vs Campaign Work
•Key points on Tech transfer
•Managing regular production
•Activities in the Product Life Cycle
- Thomas Chattaway - Senior Life Science Consultant, Independent
1:00pm - 2:00pm
Lunch
Showing 4 of 4 Streams
Next Generation Manufacturing for Emerging CGTs
RNA-based Process Development & Manufacturing
Intensifed and Continuous Manufacturing
CDMO Oversight in Biomanufacturing - Thomas Chattaway
2:00pm - 2:30pm
Lunch & Networking
2:30pm - 3:30pm
Workshop Roundup - Evolving Cell & Gene Therapy Manufacturing to the Next Generation
- Key Takeaways from the day's presentations: lessons learnt, strategies to implement new manufacturing techniques, considerations for your manufacturing processes
- Deeper dive into the case study examples shown throughout the workshop
- Hurdles and opportunities to consider
- Building diverse winning teams to ensure success
- Q&A with the day's speakers
- Amish Patel - SVP, Technical Activity Committee at NIIMBL, Calidi Biotherapeutics
- Semsi Ensari - Senior Director, Process Development, Kite Pharma, a Gilead Company
2:00pm - 2:30pm
GMP Considerations for RNA-based Therapeutics and Vaccines
- June Kim - CMC Lead, CEPI
2:30pm - 3:30pm
The Future for RNA-based Therapeutics
- Key takeaways from the day's talks: lessons from other modalities, continuous manufacturing, analytical methods, LNP manufacturing, GMP considerations.
- Emerging challenges and opportunities in RNA therapy development and manufacturing:
- Expanding target applications.
- Delivery system optimization.
- Scalable and cost-effective manufacturing for global accessibility.
- Addressing regulatory hurdles and harmonization.
- Zoltán Kis - Senior Lecturer (Associate Professor), Department of Chemical & Biological Engineering, University of Sheffield
- June Kim - CMC Lead, CEPI
- Francis Poulin, Ph.D. - Vice President, Analytical Sciences, Sail Biomedicines
- Padmadhar Madupu, MS - Director, Manufacturing, Omega Therapeutics
- John Li - Director - RNA Drug Substance, Capstan Therapeutics
2:00pm - 2:30pm
Automated mAb Mass Tracking in Continuous Manufacturing: an Enabler for Advanced Control of Downstream Loadings and Real Time Yield Monitoring
- Adrian Gospodarek - Senior Scientist, Merck
2:30pm - 3:00pm
Real-time Prediction of Critical Quality Attributes Using Raman Spectroscopy: An In-line Monitoring Model
- Yuanpu Wang - Scientist, Bristol-Meyers Squibb
3:00pm - 3:30pm
Development of Temperature-Controlled Batch and 3-Column Counter-Current Chromatography System for Improved Therapeutic Purification
- Alexander Armstrong - Process Development Senior Scientist, Amgen & University College London
2:00pm - 3:30pm
CDMO Oversight in Biomanufacturing
Session 3 :
•Managing the Interface
•Project management and organisation
•Managing Different Interests
•Risk and Conflict Management
- Thomas Chattaway - Senior Life Science Consultant, Independent
Showing 4 of 4 Streams
Next Generation Manufacturing for Emerging CGTs
RNA-based Process Development & Manufacturing
Intensifed and Continuous Manufacturing
CDMO Oversight in Biomanufacturing - Thomas Chattaway
3:30pm - 4:00pm
End of Workshop Networking
3:30pm - 4:00pm
End of Workshop Networking
3:30pm - 4:00pm
Afternoon Break
3:30pm - 4:00pm
Afternoon Break
Showing 2 of 2 Streams
Intensifed and Continuous Manufacturing
CDMO Oversight in Biomanufacturing - Thomas Chattaway
4:00pm - 4:30pm
Residence time distribution of integrated processes, a crucial parameter for characterisation of process performance
- Alois Jungbauer - Professor, Dept. of Biotechnology, University of Natural Resources and Applied Life Sciences
4:30pm - 5:00pm
Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
- Irina Ramos - Director, Bioprocess Technology and Engineering, AstraZeneca
4:00pm - 5:00pm
CDMO Oversight in Biomanufacturing
- Conclusions
- Q & A
5:00pm - 5:05pm
End of Pre Conference
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