Unlocking Genetic Potential: CordenPharma's LNP Starter Kits Safeguard High-Value Payloads on the Road to Market

CordenPharma is pleased to announce the recent launch our latest offering in the field of Lipid NanoParticle (LNP) manufacturing and development: Lipid NanoParticle (LNP) Starter Kits. These kits are designed to facilitate the formulation of mRNA in the development of cutting-edge therapeutics, including mRNA vaccines and gene therapies. Packed with essential lipid components, the starter kits empower researchers and developers to craft and fine-tune their own LNPs for efficient mRNA delivery.

Leveraging over three decades of expertise in aiding customers with lipid excipient CMC preparation, along with recent accomplishments in scaling up critical formulation aspects of a commercialized COVID-19 vaccine, our scientific experts have mastered specialized chemical processes and purification techniques. This ensures top-tier lipid quality and exceptional batch-to-batch consistency. To pre-empt potential setbacks and safeguard against compromised payload integrity stemming from inferior lipid quality, our newly introduced LNP kits feature a meticulously selected array of four essential lipids – ionizable lipids, helper lipids, sterols, and PEGylated lipids. These kits are strategically assembled using representative lipids sourced from commercial-scale material produced in-house at our CordenPharma Switzerland and CordenPharma Chenôve sites, effectively averting risks associated with transitioning lipid sources from research to clinical phases.

The LNP starter kits are meant to facilitate easy formulation screening, enabling the generation of LNPs capable of providing efficient transfection in different cell types, including immortalized 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 in our LNP manufacturing site with GFP-mRNA as cargo, and successfully implemented for synthetic RNAs (such as siRNA) and DNA as well.

With easy-to-follow 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 characterized formulations in a preclinical and clinical setting, (e.g. 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 recognized 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. As a result, our kits also feature a new highly-pure sterol, β-sitosterol, which enhances gene transfection when incorporated into LNPs, according to recent structure-activity analysis^[1} of cholesterol analogues. By leveraging years of extensive expertise gained in the process development of CordenPharma’s Botanichol^® (plant origin cholesterol), we are proud to introduce this new highly pure sterol into some of our LNP Starter kits.

[1] https://doi.org/10.1038/s41467-020-14527-2 | www.nature.com

 

Click here to place an order for CordenPharma’s LNP Starter Kits

Take advantage of our launch offer: all kit orders placed before 30 April 2024 will automatically receive a 25% discount.