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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

& Optimization

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Starting with formulation development to optimize your product’s physico-chemical properties and biological activity. Let us help you identify critical quality attributes and draft drug product specifications.

Stage 2

Process Development

for Mid-scale volume

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We have broad expertise in transferring GMP nanoparticle-based drug formulations. We optimize the Tangential Flow Filtration (TFF) and Sterile Filtration process to develop nanoparticle formulations at an intermediate scale. Our team will develop required analytical methods resulting in easier scale up. Including, install of the Blaze System at your site.

Stage 3

Process Development

for At-scale Volume

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The Clinical Solutions team can help you build your custom GMP platform to match your specifications. Formulations are transferred from the Blaze to the GMP System and a demonstration batch will be prepared at scale. Prepare GLP-Tox batch & perform release and stability testing.

Stage 4

Technology Transfer for GMP Manufacturing

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We transfer all equipment, materials, analytical methods  and provide relevant documentation and on-site training. We work with you to draft the GMP Master Batch Record and utilize IQ/OQ of GMP Manufacturing Systems at the GMP Manufacturing Site.

Stage 5

Support GMP Manufacturing , Quality

and Regulation

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To help you overcome key challenges in manufacturing nanoparticle-based formulations, we provide oversight for Engineering & GMP batches, quality and regulatory support and assist with Chemistry Manufacturing & Controls (CMC) regulatory submissions and feedback.


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

Path to 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
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

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

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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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Poster

July 01, 2018

Robust low-volume production of nanoparticles for genetic manipulation of cells

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Publication - Summary

February 27, 2018

Cell Reports

A Single Administration of CRISPR/Cas9 Lipid Nanoparticles Achieves Robust and Persistent In Vivo Genome Editing

J. Finn, A. Smith, M. Patel, L. Shaw, M. Youniss, J. Heteren, T. Dirstine, C. Ciullo, R. Lescarbeau, J. Seitzer, R. Shah...

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