The Early Advantage for mRNA: From ideation to in vivo application – with Lonza mRNA Research Services
With our new mRNA Research Services offer you can come to us with just the protein that you want to encode as mRNA.
An end-to-end offering: From pre-clinical to clinical development through to commercialization
Once you have nominated your lead compound for development, we support you with CMC activities throughout the full lifecycle of your lead candidate. Our end-to-end CMC services enable you to focus on your core activities in non-clinical and clinical development, while we deliver the required material with the essential quality.
Utilize our experts to resolve your challenges
Manufacturing a successful mRNA formulation requires seamless integration of multiple elements. It requires a smart choice and a reliable sourcing strategy for the DNA template, a stable and efficient mRNA in vitro transcription process with a smart capping approach, a stable encapsulation of mRNA in lipid nanoparticles (LNP), as well as a reliable partner for the sterile filling of vials. Lonza has the capabilities to bring all these processes together with extensive experience in managing complex manufacturing set-ups and supply chains. We provide this for mRNA/LNP manufacturing in one network at cGMP quality.
New Offering
Next generation encapsulation of nucleic acids with FDmiX
FDmiX, which was developed by FDX Fluid Dynamix and Fraunhofer IPK, utilizes a unique oscillating flow. This technology results not only in considerable process advantages (e.g. fast processing times) but also in high stability and homogeneity of LNPs, while maintaining favorable Critical Quality Attributes.
Learn more製造サイト
オランダ、Geleen - 新たなmRNA/LNPサービスと製造
Lonzaはすでに、Geleen （ヘリーン）の拠点で、細胞・遺伝子治療や商用のmRNA/LNP製造など、様々なモダリティを運用しています。将来的には、こちらの製造施設は、mRNA/LNPのプロセスおよび分析法の開発ラボ、さらに臨床cGMPの機能を備える予定です。この製造施設には、30,000平方フィート以上のラボ、cGMP製造、オフィススペースが含まれる予定です。この拡張により、製剤開発や毒性試験に適した非GMP製品や、初期および後期臨床試験用のcGMP製品の製造が可能になります。Geleen の拠点における開発サービスの拡張は、2023年初頭に開始され、cGMP対応開始は2024年第1四半期に予定されています。