CordenPharma International has announced the launch of new lipid nanoparticle starter kits for effective mRNA formulation in the development of mRNA-based therapeutics such as mRNA vaccines or gene therapies.
The starter kits provide researchers and developers with the essential components needed to create and optimise their own LNPs for mRNA delivery.
Drawing from experience spanning over three decades in supporting customers with lipid excipient CMC preparation, and more recently in scaling up key formulation elements of Spikevax to commercialisation, CordenPharma’s scientific experts have mastered chemical processes and purification steps to ensure the highest quality lipids, with good batch-to-batch reproducibility.
To mitigate potentially negative outcomes and loss of valuable payload due to subpar lipid quality, the new LNP kits, which include four key lipids (ionisable lipids, helper lipids / sterols / PEGylated lipids), are meticulously curated using representative materials from commercial-scale sources. This approach eliminates the risk associated with changing lipid sources from the R&D phase to clinical phases.
CordenPharma lipid experts designed the LNP starter kits to facilitate easy formulation screening, enabling the generation of LNPs capable of providing efficient transfection in different cell types, including immortalised and/or primary cell cultures.
The kits, which can be used for animal in-vivo applications including PK/PD studies and mRNA transfection efficacy POC/studies, have been tested with GFP-mRNA as cargo and successfully implemented for synthetic RNAs (such as siRNA) and DNA as well.
With instructions included, users can fine tune the LNP formulation process to achieve the production of nanoparticles with the desired physicochemical characteristics, such as PDI ≤0.2 and a size range between 30-150 nm (depending on the specific LNP reaction conditions, lipid composition and cargo used).
The LNP Kits consist of both well-known and characterised formulations in a preclinical and clinical setting, (e.g., Comirnaty® and Spikevax® COVID-19 Vaccines), with various combinations available to benchmark / compare LNP formulations or create completely novel compositions that elevate formulations to the next level during screening phases.
Since transfection efficiency is now being recognised as one of the next challenges in LNP formulation, a tremendous diversity of structural cholesterol analogues exist as natural products. (e.g., phytosterols that are plant-based sterols, which provide stability to the plant cell wall)
In addition, endosomal sequestration of LNPs remains a formidable barrier to delivery. Recent structure-activity analysis of cholesterol analogues reveals that incorporation of b-sitosterol into LNPs enhances gene transfection. CordenPharma’s Botanichol (plant origin Cholesterol) offers this benefit, and it can be found in some LNP Starter kits.
Dr. Matthieu Giraud, CordenPharma’s Senior Director, Global Lipids & Carbohydrates Platform, commented: “CordenPharma is proud to introduce this new LNP Starter Kit concept, as it represents a great synergy between our Lipid and LNP expertise that helps accelerate time to market and provide access to the most efficient compositions of the LNP-based drug development field for the delivery of RNA, DNA and gene therapy payloads across various important therapeutic indications, with an ultimately profound effect on saving the lives of patients.”
