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Manufacturing Platform
COVID-19 Vaccines & Genetic Medicines
PNI has had one clear mission; To accelerate the creation of transformative medicine that significantly impacts human well-being. Today our mission is more important than ever as we work together to combat COVID-19. PNI offers an integrated suite of proprietary technology, nanomedicine expertise and custom services to empower you to accelerate your work at the pace the world demands.
Manufacturing Workflow for Genetic Vaccines and Therapeutics
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Validated NanoAssemblr GMP System for centralized or in-country manufacturing of nanoparticle-based therapeutics at different scales
Modular and configurable design with experience in integrating with other technology components to build an end-to-end manufacturing solution
Clinical Solutions team with expertise to support formulation development, scale-up and tech transfer for rapid and successful GMP manufacturing
Self-Amplifying RNA Vaccine
Synthetic vaccine without the complications of a packaging cell line, contamination with replication competent virus and anti-vector immunity formulations offer a desirable alternative to viral delivery and with NanoAssemblr® technology,
these formulations can be prepared on demand in seconds.
Projections are to be able to produce 5 million human doses per liter via enzymatic synthesis
Requires an LNP delivery system specifically design for gene vaccine applications
Requires a scalable nanoparticle manufacturing platform
Once established, concept can be applied to future pandemics, raw material are generic and can be stockpiled
| Challenges with Conventional Methods | Benefits of NanoAssemblr® Technology | |
| Limited control over particle size |  | Fine-tune particle size by changing formulation parameters |
| Significant batch-to-batch variability | | Laminar conditions lead to highly reproducible mRNA lipid nanoparticles |
| Substantial material loss from low encapsulation efficiency | | Achieve high mRNA encapsulation efficacy and potency |
| A labor-intensive production process that is difficult to scale-up | | Rapidly produce formulations for screening and optimization with a straightforward path to scale-up for clinical applications |
1) An organic solvent containing dissolved lipids and an aqueous solution containing nucleic acids are injected into the two inlet channels of the NanoAssemblr® cartridge.
2) Under laminar flow, the two solutions do not immediately mix, but microscopic features engineered into the channel cause the two fluids to intermingle in a controlled and reproducible way.
3) Within a millisecond, the two fluids are completely mixed, causing a change in solvent polarity that triggers the self-assembly of lipid nanoparticles loaded with nucleic acids.
4) Changing the speed and ratio of fluid injection controls the size of the lipid nanoparticles.
5) Lipid nanoparticles mimic low-density lipoproteins, which allows them to be taken up by an endogenous cellular transport pathway to deliver nucleic acids to cells.
6) Using pH-sensitive lipids allow lipid nanoparticles to release encapsulated nucleic acids into the cytoplasm when vesicle pH decreases.
mRNA Resources
Application Note
March 15, 2022
Publication - Abstract
July 01, 2020
Journal of Controlled Release
Publication - Abstract
May 08, 2020
Vaccines
Publication - Abstract
May 31, 2019
Vaccine
Publication - Summary
May 17, 2019
Science Immunology
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