RNA Formulation Resources

1. Developing A Scalable RNA-LNP Drug Product For Clinical Translation 9/22/2022

   Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.

2. mRNA: Challenges And Strategies Related To The DNA Template Process 2/15/2023

   Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore insights on DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.

3. Harnessing Chemistry For Scalable Manufacture Of Lipids Used In mRNA Delivery 1/28/2025

   Discover how scalable lipid nanoparticle (LNP) technology is revolutionizing mRNA-based therapies and shaping the future of treatment innovation.

4. Understanding The Microfluidic Platforms For Scaling Nanoparticle Production 10/13/2022

   Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.

5. Engineering The Next Generation Of Lipid Nanoparticles For Advanced Therapeutics 6/10/2025

   Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.

6. The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine 2/18/2025

   The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

7. Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility 3/24/2023

   As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

8. LNP Formulation For mRNA Delivery 2/15/2023

   Microfluidic mixing is one of the most effective means to formulate LNPs for its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.

9. Development And Optimization Of LNP Formulations 12/6/2024

   The production of lipid nanoparticles (LNPs) is a process that demands robustness, scalability, and reproducibility. Examine the impact of key operational parameters on the efficacy of LNPs.

10. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.