Suzhou, China, 2024 — We meet with MengFei Sun, Director of the Drug Delivery department at CATUG. She is an expert in lipid nanoparticles that has been working with us since 2021.
A bit yes! I lead the drug delivery team at CATUG, where we focus on developing lipid nanoparticles (LNPs) formulations for RNA delivery. Our work includes optimizing LNP drug products and refining the manufacturing process to improve stability, scalability, and efficiency. It's a very active department, we have a lot of projects and requires a lot of collaboration to adapt to research and clinical applications.
Absolutely, after earning my degree from Northeastern University, I spent about six years at Moderna working on LNP formulation development. That experience gave me a deep understanding of LNP preparation and process optimization. In 2021, when I decided to move back to China, I learned about CATUG, a CRDMO specializing in RNA and LNP services. They were looking for someone to build their LNP drug delivery platform, which aligned perfectly with my expertise. I was also curious to experience drug development from a service provider’s perspective, which ultimately led me to join CATUG. I started as an Associate Director and grew from there.
❛❛Our proprietary MutiPlus™ platform encapsulates single and multiple payloads: pDNA, mRNA, sgRNA + mRNA, circRNA, saRNA, siRNA and tRNA❜❜
Most clients come to us with an existing LNP and RNA formulation. We help them optimize formulations and manufacture them. This requires expert hands. Formulation optimization involves studying numerous parameters—such as flow rate, solvent ratios, and lipid composition—to enhance LNP quality and performance. This makes the production more efficient and therefore more economical for our clients.
❛❛We can perform LNP in vivo characterization [...] our development pipeline enables us to deliver results in as fast as one week❜❜
We have synthesized hundreds of LNPs formulations, which makes it easy for us to recommend a product to our customers. These LNPs can be tuned to help them achieve their therapeutics goals. As a CRDMO, we can even perform in vivo characterization if needed. Another great advantage we offer is that our development pipeline enables us to deliver results in as fast as one week. Without a team with a deep expertise in LNPs, it would be much more difficult to carry out projects like this.
One of the biggest challenges is balancing stability, efficiency, and delivery. LNPs need to protect RNA from degradation while ensuring effective cellular uptake and endosomal escape. At CATUG, we can provide 95% encapsulation efficiency, which is higher than the industry standards. This helps save costs.
Another challenge is optimizing lipid composition for different payloads, whether it’s mRNA, siRNA, or other nucleic acids. This requires extensive formulation expertise and analytical testing. For this reason, we work very closely with Dr. Zhang's team from the analytical development department.
Targeted delivery is a major focus in mRNA therapeutics, researchers are exploring ligand-modified LNPs for tissue-specific delivery. Targeted LNP (tLNP) can arrive to specific tissues and organs and lead to more effective transfection and translation and fewer side effects. Our LNP bioconjugation technique helps clients direct LNPs to specific tissues and avoid hepatic accumulation.
There’s also growing interest in saRNA and circRNA, which could further enhance therapeutic efficacy. We're currently receiving a lot of projects on saRNA-LNP.
I’m especially proud of the proprietary technologies we’ve developed at CATUG. Thanks to these platforms we can provide precise, scalable, and highly efficient LNP formulations.
For example, SizeSmart™ is a technology to have precise control over LNP size (60–100 nm), we can even produce LNPs with exact target sizes for specific applications. For RNA-LNP projects, we use MaxMix™, which allows us to achieve encapsulation efficiencies of over 95% while maintaining flexibility in scalability.MultiPlus™ helps us encapsulate several RNAs in the same LNP. These innovations are what make us stand out and drive better results for our clients.
One of our key research focuses this year is targeted LNPs. We’re working on refining our bioconjugation techniques and optimizing the process to improve tissue-specific delivery. Next year, I hope to see even more promising results from both our internal research and the industry as a whole.
On a personal level, I’m always excited to see how the field evolves, especially as new discoveries push the boundaries of what’s possible with RNA-LNP therapeutics.
CATUG is a CRDMO for RNA therapeutics. We help academia and biotech companies to develop their projects efficiently, offering research support, CMC services, and GMP manufacturing. We work with labs of all sizes and stages, from research & discovery and clinical trials to product manufacturing for commercial use.