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Clinical Solutions

 

An integrated suite of proprietary technology, custom services, and nanomedicine expertise to empower our clients to create transformative medicines that significantly improve human well being. 

We Offer a Complete Solution

An integrated suite of products, services and expertise to support you through every stage.

Stage 1

 

Formulation Development

(Benchtop)

 

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We can help develop and optimize your nanoparticle’s physicochemical properties and biological activity. Let us help you identify critical quality attributes and draft drug product specifications. Our team can also help develop custom analytical methods for your nanoparticle formulations and raw materials.

Stage 2

 

Process Development

(Blaze System)

 

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The Blaze System is next used either at PNI or installed at your site to develop and establish the process parameters for preparing your nanoparticle formulations. This development work is performed at an intermediate scale, to conserve your valuable therapeutic agents. We can also assist with optimizing the downstream processing steps of your products, such as Tangential Flow Filtration (TFF) and Sterile Filtration.

Stage 3

Process Translation to GMP System

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The Clinical Solutions team can configure a GMP NanoAssemblr® System to meet your requirements. Formulations are translated from the Blaze to the GMP System confirming equivalency with demonstration batches. We can also assist with preparing and testing batches to support GLP-Tox studies.

Stage 4

Technology Transfer to GMP Drug Product Facility

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We can help you transfer equipment, materials and analytical methods to your GMP manufacturing site along with the required documentation. We can also assist with the Qualification of the GMP NanoAssemblr® System, provide on-site training and prepare product-specific GMP Master Batch Records.

Stage 5

CMC Support for GMP Manufacturing

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PNI can support your Chemistry Manufacturing & Controls (CMC) needs by providing oversight for the manufacture and testing of your Engineering & GMP batches.


Talk to a Clinical Solutions Team Member

The Clinical Solutions Team is ready for your transformative drug candidates.

Contact Us

NanoAssemblrⓇ Systems: Path to the Clinic


Quality Management System

Every customer and project is unique, requiring a tailored approach with an eye for quality and efficiency. We pride ourselves on our ability to bring our collective knowledge and expertise in Quality Management to all of our partners. PNI has developed a Quality Management System (QMS) that aligns with the requirements of 21 CFR Parts 210 and 211 such that PNI’s customers receive Scale-Up system components that are in full compliance for cGMP manufacturing.


Dedicated Team to Support Your Commercialization Needs

Precision NanoSystems has strategically placed global team members who specialize in nanomedicine development, microfluidics and instrument engineering to provide the critical bridge from clinical effectiveness to a commercially viable brand. At Precision NanoSystems, clinical and commercial disciplines work together, sharing insights and knowledge.

Padma
Padma Kodukula
VP Business Development

Dr.Kodukula previously spent 20 years in business development and program management roles at Life Technologies, Prometheus Laboratories, Biosite, Pfizer and BD Biosciences managing collaborative partnerships with molecular diagnostics and pharmaceutical companies. At PNI, Dr. Kodukula is responsible for global business development, including strategic commercial deals and alliance management.

 

She received her PhD in viral immunology from the University of Illinois in Chicago and MBA from San Diego State University.

Lloyd Jeffs
Director of Clinical Manufacturing Solutions

Dr. Jeffs brings 20 years of experience in the Biotechnology industry working Lipid-based drug delivery systems. He has expertise in formulation and process development and has played key roles in the Technology Transfer and GMP manufacture of RNA-based Lipid Nanoparticles to support multiple clinical stage product candidates.

 

He received a PhD in Applied Microbiology from the University of Saskatchewan and has previously worked for Northern Lipids Inc. and Arbutus Biopharma Corporation.


Clinical Partners
Ajinomoto
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  • "As an Evonik affiliate specialized in liposomal drug delivery systems, we are pleased to offer our clients access to the NanoAssemblr GMP System, which will aid in the translation of drug candidates to clinical testing and ideally to commercial use." 
    - Don Enns, Vice President of Evonik Vancouver Laboratories
  • "We are excited about this promising collaboration and hope that it will propel our work forward as the ncRNA Core Facility focuses on the non-coding RNA portions of the genome for [the] discovery of novel biomarkers and targets for therapeutics from human disease tissue and clinical trial specimens."
    - Frank Slack, Director of the Harvard Medical School Initiative for RNA Medicine (HIRM) at BIDMC
  • "Ajinomoto Bio-Pharma Services has audited the PNI facilities in Vancouver and has qualified PNI's NanoAssemblr® GMP System and its components. We are excited to work with PNI to offer their purpose-designed manufacturing technology and unique nanomedicine expertise to our clients for the manufacture of nanoparticle-based medicines" 
    - Kristin DeFife, Ph.D., Vice President and Head of US Operations of Ajinomoto Bio-Pharma Services
>

Get Started

To learn how Precision NanoSystems accelerates nanomedicine development from an idea to clinical applications, contact our Technical Sales Team.

Get in Touch

Resource Center

Publication - Summary

May 18, 2019

Annals of Hematology

Lipid nanoparticle-mediated siRNA delivery for safe targeting of human CML in vivo

N. Jyotsana, A. Sharma, A. Chaturvedi, et al.

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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

April 04, 2019

The Journal of Neuroscience

PTCD1 is required for mitochondrial oxidative-phosphorylation: possible genetic association with Alzheimer's disease

D. Fleck, L. Phu, E. Verschueren, T. Hinkle, M. Reichelt, T. Bhangale, B. Haley, Y. Wang, R. Graham, D.S. Kirkpatrick, M...

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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 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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