Liquids in Dishes in a Lab

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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GMP process

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Blaze + GMP Framework 3_1

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.

Screen Shot 2020-04-13 at 7.53.38 AM

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 sizeorangeRightArrowFine-tune particle size by changing formulation parameters
Significant batch-to-batch variabilityorangeRightArrowLaminar conditions lead to highly reproducible mRNA lipid nanoparticles
Substantial material loss from low encapsulation efficiencyorangeRightArrowAchieve high mRNA encapsulation efficacy and potency
A labor-intensive production process that is difficult to scale-uporangeRightArrowRapidly produce formulations for screening and optimization with a straightforward path to scale-up for clinical applications

How It Works

mRNA Production and Delivery



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

Publication - Abstract

May 08, 2020

Vaccines

Investigating the Impact of Delivery System Design on the Efficacy of Self-Amplifying RNA Vaccines

G. Anderluzzi, G. Lou, S. Gallorini, M. Brazzoli, R. Johnson, D.T. O'Hagan, B.C. Baudner and Y. Perrie

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Publication - Abstract

May 31, 2019

Vaccine

mRNA Vaccines Against H10N8 and H7N9 Influenza Viruses of Pandemic Potential Are Immunogenic and Well Tolerated in Healthy Adults ...

R.A. Feldman, R. Fuhr, I. Smolenov, A. Ribeiro, L. Panther, M. Watson, J.J. Senn, M. Smith, Ö. Almarsson, H.S. Pujar, M....

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Publication - Summary

May 17, 2019

Science Immunology

A lipid-encapsulated mRNA encoding a potently neutralizing human monoclonal antibody protects against chikungunya infection

N. Kose, J.M. Fox, G. Sapparapu, et al.

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Publication - Summary

February 07, 2019

Nano Research

Chemotherapy drugs derived nanoparticles encapsulating mRNA encoding tumor suppressor proteins to treat triple-negative breast can...

C. Zhang, X. Zhang, W. Zhao, C. Zeng, W. Li, B. Li, X. Luo, J. Li, J. Jiang, B. Deng, D.W. McComb, Y. Dong

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Application Note

January 16, 2019

mRNA Lipid Nanoparticles: Robust low-volume production for screening high-value nanoparticle materials

Read More 阅读更多 PDF

Publication - Summary

September 24, 2018

Nucleic Acid Therapeutics

MicroRNAs Enable mRNA Therapeutics to Selectively Program Cancer Cells to Self-Destruct

R. Jain, JP. Frederick, EY. Huang, KE. Burke, DM. Mauger, EA. Andrianova, SJ. Farlow, S. Siddiqui, J. Pimentel, K. Cheun...

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Resource Center 资源中心

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