RNA Formulation Resources

1. Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing 6/12/2023

   Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.

2. Where Can Novel Non-Viral Polymeric Delivery Agents Take Us? 1/18/2023

   Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.

3. A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy 4/14/2022

   We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.

4. Translation Of RNA Medicines From Design To Clinic 3/2/2022

   Understand the advantages and challenges of lipid-based delivery systems for successful translation of RNA into clinical development.

5. Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier 8/21/2023

   Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.

6. Optimized And Scalable LNP Composition For RNA Vaccine Delivery 12/20/2023

   Explore results from a study screening novel LNP formulations for physicochemical attributes, in vitro potency, and in vivo immunogenicity in both SARS-CoV-2 and influenza vaccine applications.

7. Avoiding The Pitfalls Of LNPs And Complex Formulations

   Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

8. Lipid Nanoparticle Library For Non-Viral Delivery Of mRNA And saRNA Towards Vaccine And Cell & Gene Therapy Applications 4/18/2022

   Explore this proprietary ionizable lipid library which has shown promising potency towards various applications involving cell therapy, protein replacement therapy and RNA-based Vaccines.

9. Scale-Up And Manufacturing Of Self-Amplifying RNA-LNPs 4/18/2022

   This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.

10. 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.