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Pre-Conference Workshops - PST/PDT (Pacific Daylight, GMT-7)
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Pre-Conference Workshops - PST/PDT (Pacific Daylight, GMT-7)
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8:00am - 8:55am55 mins
Coffee and Registration
8:55am - 9:00am5 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Chairperson's Opening Remarks
8:55am - 9:00am5 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Chairperson's Opening Remarks
9:00am - 9:30am30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Challenges and Opportunities for mRNA Replace Therapeutics
- Jin Zhou - Executive Director, Process Development, mRNA and Protein biologics, Ultragenyx Pharmaceutical Inc
9:00am - 10:00am60 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Enabling an End-to-End Continuous Platform and Pilot Pant
- Tom Ransohoff - Technical Lead, National Resilience, Inc.
9:00am - 10:30am90 mins
Pre-Conference Workshop: Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Venkat Balakrishnan - Senior Business Solutions Consultant, Körber Pharma
9:00am - 10:30am90 mins
Pre-Conference Workshop: Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
9:00am - 10:30am90 mins
Pre-Conference Workshop: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
9:30am - 10:00am30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Quality by Digital Design and Techno-Economic Modelling of RNA Vaccine Production
- Zoltán Kis - Research Associate, Imperial College London
10:00am - 10:30am30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Flocculation of a Virus-like nanoparticle using a cationic polymer and evaluation with a particle analyzer probe
- John Taylor - Sr. Process Development Scientist, MilliporeSigma
10:00am - 10:30am30 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Consensus Standard E3326-22 Facilitates Acceptance of Continuous Biomanufacture
- Duncan Low - President, Claymore Biopharm
10:30am - 11:00am30 mins
Morning Networking Break
11:00am - 11:30am30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Development of Automated High Throughput Method for In Vitro Transcription of mRNA
- Karenna Smith - Senior Associate Scientist, Pfizer
11:00am - 12:00pm60 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Coping with High Cell Densities in End-to-End Processing
- Irina Ramos - Director, AstraZeneca
- Ken Lee - Associate Director, AstraZeneca
11:00am - 12:30pm90 mins
Pre-Conference Workshop: Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Venkat Balakrishnan - Senior Business Solutions Consultant, Körber Pharma
11:00am - 12:30pm90 mins
Pre-Conference Workshop: Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
11:00am - 12:30pm90 mins
Pre-Conference Workshop: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
11:30am - 12:00pm30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Redefining the definition of “compendial method”
- Elena Smith - Analytical CMC Leader - Vaccine, Sanofi
12:00pm - 12:30pm30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Understanding mRNA Degradation in LNP Delivery Systems
- Dipendra Gyawali - Sr. Scientist, Team lead, Process development Characterization, Moderna
12:00pm - 12:30pm30 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Applications to Further Intensify Perfusion Processes to Have High Volumetric Productivity
12:30pm - 1:30pm60 mins
Lunch
1:30pm - 2:00pm30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
De-risk mRNA Adduct Formation in Lipid Nanoparticle Formulation Intended for Glycogen Storage Disease Type-1a Using Base Editing
- Siddharth Bhoraskar - PhD Scientist II, Analytical Research & Development, Beam Therapeutics
1:30pm - 2:30pm60 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Process Intensification and Perfusion Technologies for Greater Productivity
1:30pm - 2:30pm60 mins
Pre-Conference Workshop: Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
Towards QbD guided Model-based process development
- Michael Sokolov - COO, DataHow
1:30pm - 2:30pm60 mins
Pre-Conference Workshop: Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
1:30pm - 2:30pm60 mins
Pre-Conference Workshop: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
2:00pm - 2:30pm30 mins
Pre-Conference Workshop: Future of mRNA-based Therapeutics/Vaccines
Regulatory Landscape of mRNA
2:30pm - 3:00pm30 mins
Afternoon Networking Break
3:00pm - 3:30pm30 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Flexible Process Intensification & Modification of Downstream mAb Processes for Increased Productivity
- Debola Banerjee - Associate Director, Protein Science, Boehringer Ingelheim
3:00pm - 3:30pm30 mins
Pre-Conference Workshop: Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
Constraint-based reconstruction and analysis (COBRA) Toolbox for mechanistic modelling
- Nathan Lewis, PhD - Professor, Departments of Pediatrics and Bioengineering, University of California, San Diego
3:00pm - 5:00pm120 mins
Pre-Conference Workshop: Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
Principles and Practices of CMC Analytics for Cell and Gene Therapy Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
3:00pm - 5:00pm120 mins
Pre-Conference Workshop: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
3:30pm - 4:00pm30 mins
Pre-Conference Workshop: Intensified & Continuous Processing
Interactive Panel Discussion - What do the Vendors Need to do Regarding Continuous? Picking Up the Slack and Filling in the Gaps
3:30pm - 4:00pm30 mins
Pre-Conference Workshop: Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding / Analytical & Quality Case Studies
Documents, Requirements and Validation of Software To Support Manufacturing
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