Pharma Focus Asia
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Improving the safety of your LNP-mRNA therapeutics and vaccines by utilizing monolithic chromatography

Lipid nanoparticle (LNP) based therapeutics and vaccines have been at the forefront of the non-viral delivery since SARS-CoV-2 vaccines rolled out and proved their worth. LNP’s safety profile is a critical attribute that must be considered during its formulation and manufacturing. Major safety issues can stem from the heterogeneity of LNPs, including the presence of impurities such as empty particles, and fused or aggregated particles. These issues can be addressed by utilizing monolithic chromatography at both, analytical and preparative level.

Lipid nanoparticles enable a high degree of modularity depending on the desired outcomes. Manufacturing of LNPs provides a major advantage over established viral vector therapies due to its easy to formulate and scale characteristics. All that modularity enables large diversity of LNP properties and heterogeneity within the samples. However, LNP formulation typically requires a considerable effort to achieve an optimal outcome.

Commonly, it is very difficult to accurately predict in-vivo LNP activity and immunogenicity. Better, faster and more insightful analytical methods are needed to better predict LNP effectiveness, safety and stability, so that the development of therapeutics can be accelerated at a lower cost.

In this webinar, a novel chromatographic approach utilizing monolithic columns will be presented for determination of crucial LNP parameters such as encapsulation efficiency, particle size, nucleic acid quantity and integrity, all measured without any sample pretreatment. In addition, the webinar will demonstrate monolithic chromatographic analytical methods with applications to monitoring critical quality attributes in mRNA LNP production.

The webinar will cover unique suitability of monolithic columns for LNPs as they are made from one piece with large pores that exhibit minimal shear stress to the nanoparticles and can thus keep particles intact. Various diverse surface modifications of the monoliths can be made to achieve the desired LNP binding selectivity. LNP particles can thus be separated based on their size, charge, hydrophobicity, hydrophilicity, hydrogen bonding or a combination of those. This unique selectivity of monolithic columns offers a powerful insight into the LNP composition and structure.

Participants will learn about

  • Using chromatography to analyze and purify lipid nanoparticle-based therapeutics.
  • Understand your drug product beyond the size and encapsulation efficiency.
  • Innovative methods for analysis that do not require sample pre-treatment for separate component analysis.
  • Characterize in detail you drug substance within your drug product.
  • Purify, concentrate and buffer exchange your LNP-based drug product with monolithic chromatography.

Who should Attend:

LNP formulation specialists, R&D directors, Chromatography experts, Downstream experts, Drug substance experts, Regulatory associates, R&D Project managers

3rd Sept 2024

08:00 CEST

Speaker:

Andreja-speaker

Andreja Gramc Livk

Head of Process Analytics; Sartorius BIA Separations

Andreja Gramc Livk

Andreja is a Head of Process Analytics Development department at Sartorius BIA Separations. She leads process analytics development team that focuses on the further advancement of a chromatographic solutions, involving the development of innovative analytical methods for the analysis of biological molecules, including mRNA, pDNA and viruses. Over the course of career with biotech companies, she gained a wide range experience in protein chemistry, including characterisation of biosimilars and biologics. She holds a Master Science in Biochemistry from the University of Ljubljana, Slovenia.

speaker-tristan

Tristan Kovačič

Scientist; Sartorius BIA Separations

Tristan Kovačič

Tristan Kovačič is a Scientist in the Process analytics development department of Sartorius BIA Separations. He holds an MSci degree in Chemistry from Imperial College London. He has extensive experience in the non-viral delivery field, particularly in the process and analytics development of these therapeutics.