CHAIR - Sanyogitta Puri, Senior Director, Head, Non-Viral Delivery, Novo Nordisk

Showcasing Successful Strategies to Reduce Liver Clearance & Involve Endogenous Mechanisms for Optimizing Extrahepatic Targeting

11:00am: Endogenous Mechanisms for Targeted Delivery of Nucleic Acid Therapy with Lipid Nanoparticles

• Showcasing strategies for engineering LNPs to attract proteins to enhance extrahepatic delivery
• Using immune cells to deliver LNPs to the target sites to enable cell-specific targeting
• Enhancing bystander effect by delivering LNPs and encouraging production of exosomes to increase density of delivery to cells in the area

Mansoor Amiji, University Distinguished Professor, Northeastern University

11:30am: Biodegradable Lipid Nanoparticles with Tunable Immunogenicity

• COATSOME® SS Series consist of a library of biodegradable lipids with increased in vivo potency and tolerability
• Immunogenic and Non-immunogenic lipids were developed for vaccine and gene therapy applications respectively
• High throughput screening methods will be employed to generate novel LNP compositions for new applications

Syed Reza, Drug Delivery Consultant, NOF Corporation

12.00pm: Improving Formulation & Design of Targeted LNPs to Unlock the Potential of Extrahepatic Delivery

• Delving into strategies for reducing liver tropism and toxicity of targeted LNPs
• Uncovering improved formulations for better stability and greater shelf life
• Optimizing and characterizing tLNPs for enabling cell specific delivery

Bo Ying, Chief Executive Officer, Abogen Biosciences

12.30pm: Lunch Break & Networking

Achieving Muscle-Selective Delivery Through Customized Ionizable Lipids to Develop Vaccines Against More Diseases

1:30pm: Discovery of Novel Ionizable Lipids for the Intramuscular Delivery of mRNA Vaccines

• A general overview on LNP based mRNA delivery system for the development of mRNA vaccine platform
• Design and synthesis of novel ionizable lipids for the efficient delivery of mRNA vaccines
• Focus on building Structure Activity Relationship (SAR) of novel ionizable lipids with improved immunogenicity and reduced reactogenicity towards the development of effective mRNA vaccines

Saswata Karmakar, Director, Chemistry, Sanofi

2:00pm: Novel Design of Ionizable Lipids & LNP Formulations for Nucleic Acid Delivery Leading to CAR Knock-In

• Introduction of our proprietary ionizable lipid library in vivo
• Ready-to-use LNP for ex vivo studies
• Ex vivo Application-1:  knock-out in human primary T cell
• Ex vivo Application-2:  pDNA delivery to human primary T cell
• In vivo Application: extra-hepatic lipids which were found from ex vivo studies

Shinichi Hashimoto, Head, LNP Formulation Discovery, FUJIFILM Corporation

2:30pm: Muscle-Selective Ionizable Lipid-Based mRNA-LNP & their Applications in Novel Vaccine Development

• Muscle-selective gene delivery by novel ionizable lipidbased LNP
• Enhanced safety through minimized systemic exposure
• Promising vaccination efficacy against various infectious diseases

Jee-Young Park, Executive Director, MediciBIO

3:00pm: Afternoon Networking Break & Scientific Poster Session

Contribute to the conversation and share your cutting-edge research with your fellow LNP community to showcase your breakthrough discoveries to a vast audience of experts. Register your place to submit an abstract for review to showcase your poster*

Exploring LNP Formulations with Improved Translation Potential for Prevention & Treatment of Cancer, Infection & Beyond

4:00pm: Optimizing Tissue Distribution & Safety of LNPMediated Prophylactic Vaccines to Accelerate Prevention of Infection & Disease

• Preclinical immunogenicity and efficacy of prophylactic vaccines
• Tissue distribution and safety profile of prophylactic vaccines
• Preclinical efficacy study of mRNA-based protein replacement therapy for rare disease(s)

Jingsong Cao, Senior Research Fellow, Innorna

4:30pm: Phospholipids for LNP Applications

• Safety and efficacy of phospholipids make them ideal excipients
• The composition and purpose of phospholipids in LNP vaccines, from enhancing endosomal escape to targeting specific tissues
• Phospholipids and their role in adjuvanted liposomal vaccines

Alexander Aydt, Senior Manager, Business Development, Lipoid

5.00pm: Nanolipid Innovations: Revolutionizing Cancer Prevention & Treatment

• Overview of in-house developed combination drug lipid nanoformulations for cancer treatment
• The landscape of formulation patents and translational potential
• Exploring targeted and bioenhancer lipid nanocarriers across the cancer spectrum

Preshita Desai, Assistant Professor, Biotechnology & Pharmaceutical Sciences, Western University of Health Sciences

5:30pm: Chairs Closing Remarks

CHAIR - Sanyogitta Puri, Senior Director, Non-Viral Delivery, Novo Nordisk

CHAIR - Alexey Popov, Vice President, Head, Process Development, Sail Biomedicines

Leveraging Robust Process Strategies to Optimize LNP Purification & Manufacturing for Streamlined Translation

11:00am: Developing a Successful Phase 1 Manufacturing Strategy for an mRNA-Based Cancer Vaccine

• Developing novel lipids and LNPs for mRNA cancer vaccines
• Development of drug product
• Tech transfer and scale-up of lipids, mRNA and mRNALNPs

Rajesh Krishnan, Senior Director, Formulation, Providence Therapeutics

11:30am: Development & Optimization of TFF Purification for Lipid Nanoparticles: Advancing Yield & Purity

• The development of an efficient tangential flow filtration (TFF) purification process for lipid nanoparticles (LNPs) is critical for advancing the production of biopharmaceuticals, particularly in the context of xRNA/xDNA-based therapies
• This presentation will focus on the early-stage application of TFF purification at CordenPharma, a global Contract Development and Manufacturing Organization (CDMO) recognized for its expertise in complex modalities and advanced medical therapies. CordenPharma is at the forefront of providing end-to-end solutions for the development and manufacturing of drug products, including cutting-edge LNP formulation and in general Nanomedicine services
• The presentation will highlight strategies used to optimize the purification of LNPs during the initial stages of development. Key challenges such maintaining the desired Quality Target Product Profile (QTPP) including particle integrity, scaling up processes, and ensuring high purity will be addressed, alongside innovative approaches implemented to streamline purification workflowsUmberto Romeo, Global Head of Development, Injectables & Nanomedicines, Corden Pharma

12:00pm: Roundtable Discussion: Evaluating Key Considerations & Platforms for Designing a Robust Process to Achieve Large Scale Production

• Discussing key considerations and parameters in the process understanding assessment to avoid expensive mistakes.
• How to predict robustness and scalability early on to design a more efficient process later on?
• How to optimize, improve and implement platforms to accelerate better process design and development?

Ami Jo, Associate Director, Process Development, Omega Therapeutics

12:30pm: Lunch Break & Networking

Identifying Key Considerations to Scale-Up LNP Manufacturing with Reduced Variation Across Batches

1:30pm: Optimizing Formulation & Early Process Development Strategies to Enable Scale-Up of Novel LNPs

• Sharing new and innovative formulations for novel LNPs which are thermostable and PEG free
• Translating these new LNP formulations to early process development with optimized manufacturing and scalability
• Showcasing a proof of concept of scaling-up a proprietary LNP platform

George Dakwar, Director, Formulation Platform, CureVac

2:00pm: Session Details to be Revealed

2:30pm: Identifying Critical Parameters & Considerations for Successful Scale-Up of LNPs

• Discussing key parameters and variables which need to be considered when scaling-up LNP production and optimizing process development
• Evaluating how in vitro testing and animal study results change when you go from small scale LNP production to large scale
• Uncovering how equipment selection impacts formulation

Alexey Popov, Vice President, Head, Process Development, Sail Biomedicines

3.00pm: Afternoon Networking Break & Scientific Poster Session

Contribute to the conversation and share your cutting-edge research with your fellow LNP community to showcase your breakthrough discoveries to a vast audience of experts. Register your place to submit an abstract for review to showcase your poster*

Accelerating LNP Production with Optimized Process & Advanced Manufacturing Strategies

4.00pm: Process Optimization for Gene Therapy LNP Production Via Design of Experiment

• Identification of Critical Process Parameters via DoE (Design of Experiment)
• Filling the gap between processability and biological potency
• Scaling-up tech transfer, small scale to large scale

Qook Lee, Research Advisor, Eli Lilly & Co

4.30pm: Parallelization of Microvortex Mixers Enables Scalable Manufacturing of mRNA-LNPs While Preventing mRNAs from Being Truncated Under Controlled Shear Rates

• Controlled shear rates deliver intact mRNAs into LNPs for the scalable manufacturing
• Advanced microvortex mixers made of stainless steel enables cost-effective discovery in good translation to manufacturing
• Feedback controlled operation secures high-quality production of LNPs

YongTae Kim, Chief Executive Officer, Mepsgen

5.00pm: Uncovering Advanced Strategies for Continuous Manufacturing to Accelerate Production of LNPs

• Showcasing what continuous manufacturing is for LNPs to fast-track their production
• Unleashing the advantages of continuous advanced manufacturing over traditional manufacturing processes
• Uncovering the impact of continuous manufacturing on stability and real-time analysis of the LNPs

Diane Burgess, Distinguished Professor, University of Connecticut

5:30pm: Chairs Closing Remarks

CHAIR - Alexey Popov, Vice President, Head, Process Development, Sail Biomedicines