Formulation White Papers & Case Studies

1. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/21/2024

   Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

2. PEG In LNP Formulations: Addressing Challenges And Seeking Solutions 2/8/2024

   Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.

3. The Heroes Of Vaccine Development: Lipid Nanoparticles 2/8/2024

   Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.

4. How To Make The Best LNPs 1/22/2024

   There are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation.

5. Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development 12/27/2023

   Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.

6. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

   The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

7. Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges 7/21/2023

   Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.

8. Lipid Nanoparticle Compositional Analysis By UHPLC-CAD 6/30/2023

   Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

9. Expectations On The Pathway To GMP For Gene-Modified Cell Therapies 6/21/2023

   Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

10. Establishing Analytical Methods For mRNA-Based Therapies 6/13/2023

    Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.