Conference Day Two- Thursday, September 19

8.00 Morning Networking Coffee

8.50 Chair’s Opening Remarks

  • Jim Nolan Vice President Head Of Technical Operations, Senda Biosciences

Implementing Quality by Design Principles to Optimize mRNA Drug Manufacturing for Cost, Speed & Effectiveness

9.00 Leveraging Quality by Digital Design for Flexible Continuous mRNA Manufacturing

  • Zoltán Kis Senior Lecturer (Associate Professor), University of Sheffield

Synopsis

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10.00 Exploring the Innovation Journey & Real-World Application of NtensifyTM Technology

Synopsis

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10.30 Morning Networking Break

Research Scale Track
Chair: Travis McQuiston, Senior Director, Scientific Research, Turn Biotechnologies

Enhancing mRNA-LNP Stability: Scaling Up Drug Product Manufacturing Through Lyophilization

10:45 mRNA-LNP Drug Product Stability: Leveraging Freeze Drying for Thermostability Improvement & Stability Kinetics Modelling as a Decision Tool For Formulation Selection

Synopsis

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11.15 Development & Qualification of Small-Scale mRNA Lipid Nanoparticle Manufacture

  • Brenda Clemente Associate Director, Head of Formulation and Process Development, Arcturus Therapeutics

Synopsis

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11.45 Roundtable Discussion: Enhancing mRNA-LNP Stability: Scaling Up Drug Product Manufacturing Through Lyophilization & More

Synopsis

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IND-Enabling & Clinical Scale Track
Chair: Craig Martin, Professor, University of Massachusetts Amherst

Accelerating Scale Out into the Clinic for Personalized mRNA Therapeutics & Vaccines to Ensure Cost Effectiveness & Speed

10.45 Development of an End-to-End Manufacturing Process for mRNA-Based Personalized Cancer Vaccines

  • Hang Yuan Chief Technology Officer, Innovac Therapeutics

Synopsis

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11.15 Comprehensive Characterization of mRNA Vaccines & Therapeutics with eMERGE

  • Wayne Doyle Head of Platform, Eclipse BioInnovations, Inc.

Synopsis

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11.45 Scalable Microfluidic Factories to Manufacture mRNA Personalized Cancer Vaccines

  • Babak Sanii Associate Director Biochip R&D, Nutcracker Therapeutics

Synopsis

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12.15 Development of a Continuous Manufacturing Solution for All-Scale mRNA-LNP Production

Synopsis

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12.25 Lunch Break & Networking

Accelerating the Development of Novel mRNA Vaccine Platforms to Combat Infectious & Oncological Diseases

1.25 Setting Up a Faster, More Cost-Efficient & Effective Platform to Manufacture Personalized Cancer Vaccines

Synopsis

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1.55 Toward the Development of a Broad-Spectrum Multi-Antigen Next Generation SARS-CoV-2 Vaccine

Synopsis

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Scaling Up Drug Product Manufacturing: Improving Formulations Through Novel Mixing Systems

1.25 Untangling How RNA Quality Affects Safety & Immunogenicity in In Vitro & In Vivo Models

Synopsis

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1.55 Roundtable Discussion: Evaluating Formulation Feasibility and Optimization Strategies for mRNA-LNP Therapies: Key Considerations for Clinical Advancement

Synopsis

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2.25 Afternoon Networking Break

Transitioning from Early Phase Clinical to Commercial Scale: Planning for the Future of Successful mRNA Manufacturing

3.10 Looking Ahead to a Commercial Ready Process: Beyond the IND

  • Ami Jo Associate Director, Process Development, Omega Therapeutics, Inc.

Synopsis

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3.40 Tech Transfer of Late Phase & Commercial mRNA Manufacturing

Synopsis

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4.10 Chair’s Closing Remarks

  • Jim Nolan Vice President, Head of Technical Operations, Sail Biomedicines

4.15 End of 3rd mRNA Process Development & Manufacturing Summit

EVENT GUIDE
DAY ONE