Formation & Refinement of LNP

Formation & Refinement of LNP

The formation of lipid nanoparticles (LNPs) is a critical phase in developing mRNA therapeutics. Finishing this step indicates that you are ready to proceed with a selected formulation that shows promise for your clinical target. This stage also requires further in vitro and in vivo demonstrations of your drug substance (mRNA) and drug product (LNP-mRNA) to fully characterize the safety and efficacy of your therapeutic.

Depending on your stage of development and scale, mixing lipid components and mRNA can be done with liquid handlers or microfluidic devices. A Beckman Coulter Life Sciences Optima AUC can help assess payload copy numbers.

During the demonstration phase, you must understand how your therapeutic performs in vitro and in vivo. The bioanalysis of lipids, lipid impurities and metabolites, mRNA poly(A) tails and 5’-caps can be performed using a SCIEX ZenoTOF 7600+ system for data-driven decision-making. The SCIEX BioPhase 8800 system and PA 800 Plus system utilize capillary electrophoresis to test mRNA integrity and purity and estimate size and encapsulation efficiency. The protein levels in functional in vitro assays can be quantitatively determined using the SCIEX 7500+ system and the SCIEX ZenoTOF 7600+ system with SCIEX OS software. Cell-based assays for evaluating the toxicity and potency of LNP formulations can leverage the Molecular Devices SpectraMax iD3 Multi-Mode Microplate Reader.

Robust data management supports the standardization of LNP formation protocols and the documentation of demonstration results. This ensures that the formation process can be consistently replicated and validated. Consolidating, organizing and analyzing drug substances and drug products is essential. Genedata and IDBS provide scalable, enterprise-level cloud software products from R&D through manufacturing for assured confidence in both GxP and non-GxP environments.

Out-of-the-box, the Genedata Biopharma Platform enables highly sensitive MS-based characterization and monitoring of critical quality attributes (CQAs) during the LNP formation process. The Genedata platform also automates the analysis of plate-based and imaging assays that inform on safety, toxicity, cell trafficking, and protein expression. Furthermore, it provides a domain-specific structured data backbone to capture, track, and integrate data from LNP formation workflows, including raw materials, process parameters, and results for efficient decision-making. By leveraging numerous APIs, the system connects directly to instruments and facilitates maximum workflow automation.

IDBS Polar is a fully configurable drug development workflow and data management software platform. IDBS Polar enables scientists to capture experiment, inventory, analysis, equipment and operational data at the point of execution in a sophisticated data backbone that enables actionable insights and drives data-driven decision-making.

Alongside IDBS Polar’s structured data capture capabilities, it offers numerous APIs and instrument connectors to seamlessly move data in and out of Polar with ease. Combined with inventory management and genealogical tracking capabilities, scientists can consistently characterize safety and efficacy product data and gain reliable actionable insights

If your laboratory lacks the necessary safeguards and personnel—requirements that often require significant investments—or if you prefer not to manage multiple partnerships, consider outsourcing your LNP work to a reliable partner like Aldevron. Aldevron can support you throughout the entire mRNA-LNP therapeutic process, from creating plasmids and in vitro transcription of mRNA to analytical development and validation to process development and manufacturing.