From Bench to Scale: Scaling Biodegradable mRNA Lipid Nanoparticle for Clinical Success

This webinar will introduce participants to the challenges and considerations in development and scale-up of mRNA lipid nanoparticles (LNPs) composed of biodegradable lipids. Attendees will learn the role of individual lipid components in formulation design and strategies to maximize impact on potency, tolerability and scalability for commercial success. Subsequently, a case study will be presented highlighting the scale-up of an LNP formulation, including upstream microfluidic mixing optimization and downstream processing via tangential flow filtration (TFF).

Lipid nanoparticles (LNPs) are the leading non-viral delivery system and are being developed for the treatment of a wide range of diseases and genetic conditions. During the preclinical development phase, LNP formulations are optimized for potency and safety based on the target disease indication and route of administration. To support the early stages of development, small-scale LNP batches are often fabricated using microfluidics and downstream processing via dialysis and ultrafiltration. These small-scale unit operations are material sparing, efficient and yield high-quality LNPs.

Upon selection of a lead formulation, a critical next step towards investigational new drug (IND)-enabling studies involves scaling up the LNP fabrication process, including upstream mixing and downstream purification processes. Microfluidic and turbulent mixing options are available for the upstream unit operation, whereas TFF is commonly utilized for downstream purification and product concentration. During scale-up, the LNP critical quality attributes must be maintained, including particle size, PDI and cargo encapsulation efficiency.

Register for the webinar to gain practical insights into the formulation and scale-up of biodegradable lipid nanoparticles for mRNA delivery.

Speakers

Syed Reza, MD-PhD, Licensing and External Innovation Alliance Management, Drug Delivery Solutions, NOF Corporation

Syed Reza brings twenty years of experience in biopharma and specializes in nanomedicine technology. Syed currently leads the External Innovation and Alliance activities at NOF Corporation for the Drug Delivery Solutions business unit. Recently, Syed has consulted for various CDMOs on commercial strategy in the manufacturing of complex biologics, including for Octoplus B.V, a Dutch nanomedicines company.

At Octoplus, Syed was responsible for securing partnerships on platforms for protein microspheres and lipid nanoparticles. These efforts led to the successful acquisition of Octoplus by Dr Reddys Laboratories in 2012. Prior to joining Ootoplus, Syed was part of the large-scale peptide manufacturing team at Hoffman LaRoche and led efforts to launch the CDMO business and acquire two Phase III manufacturing contracts.

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Nicholas Boylan, PhD, Sr. Director, Scientific Services, Phosphorex

Nicholas Boylan is the Senior Director of Scientific Services at Phosphorex, where he plays a pivotal role in advancing the company’s mission to be a customer-centric, technically driven contract development and manufacturing organization (CDMO) specializing in particle-based drug delivery systems. With deep expertise in the development of lipidic and polymeric formulations, he is instrumental in shaping Phosphorex’s innovative approaches to drug delivery.

Before joining Phosphorex, Dr. Boylan led the analytical and formulation development of a novel soft-mist pulmonary inhaler at Molecular Infusions. He also made significant contributions to the encapsulation of diverse payloads within a proprietary nanomedicine platform at BIND Therapeutics. He holds a Bachelor’s Degree in Chemical and Biomolecular Engineering from Cornell University and a PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.

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