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Biopharmaceutical

Services

Combining disruptive technology platforms with unparalleled genomic medicine development expertise, Precision NanoSystems’ Biopharmaceutical Services accelerates the development of lipid nanoparticle (LNP) formulations and drug products. 

Expertise to Accelerate Preclinical and Clinical Drug Development 

 

Partner with Biopharmaceutical Services to accelerate formulation development, optimization and process scale-up. Our Biopharmaceutical Services can aid in design of payload and offer analytical development, bioassay development and QC (analytical) support throughout your research program. Our expert team of scientists optimizes the use of limited materials in scaling drug products from discovery to large-scale manufacturing for a broad range of payloads and carriers with the NanoAssemblr® and GenVoy™  technology platforms. Get started with a well-defined project plan and milestones, deliverables, timeline and budget customized to your needs. 

 

 

26*


Clinical Stage Programs

>44*


GMP Batches

2*


Approved Drugs

*Precision NanoSystem’s Biopharmaceutical Services team is made up of experts that bring in their cumulative experience of working with 26 clinical stage programs producing over 44 GMP batches and have contributed to two approved drug products.
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Complete Solutions for Every Step of Pharmaceutical Development 

Partner with Biopharmaceutical Services on projects that span the entire drug development process, including proof-of-concept studies in early discovery, lead candidate development in scale-up and optimization and technology transfer of manufacturing processes for cGMP production. 

 

 

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Formulation Development  

  • Optimize physicochemical properties and biological activity 
  • Identify critical quality attributes (CQAs) and draft drug product specifications 

Process Development icon

Process Development 

  • Establish critical process parameters (CPPs) for downstream processing, including tangential flow filtration (TFF) and sterile filtration 

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Scale-Up  

  • Confirm equivalency with demonstration batches   
  • Prepare and test batches to support GLP-Tox studies

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Technology Transfer & Manufacturing 

  • Transfer equipment, materials and analytical methods to GMP manufacturing site 
  • Prepare GMP Master Batch Records
  • Manufacture GMP batches for Phase I and II clinical trials 

CMC

Chemistry Manufacturing & Controls (CMC) Support 

  • Provide oversight for the manufacture and testing of engineering and GMP batches  
  • Assist with CMC Regulatory Submissions

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Bioassay Development and Screening 

  • Develop robust bioassays to evaluate the potency and in vitro gene expression of any drug payload  
  • Develop a workflow to screen large numbers of variables to support formulation and process development  

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Analytical Services 

  • Develop analytical methods for nanoparticle formulations and raw materials 

 

Analytical Services

 

Developing the right analytical assays for each stage of your project is critical to ensure success in the path from preclinical to clinical drug development. With deep expertise and technical knowledge of genomic medicines, Biopharmaceutical Services develops and applies advanced analytical methodologies to support the characterization of the drug substance, raw materials and/or nanoparticle formulation. Our analytical development team works across the preclinical, clinical, process development, manufacturing and quality teams from selecting lead candidates during formulation development to ensuring specifications of the drug product remain consistent as production is scaled.

 

 

Analytical Capabilities

Analytical services for non-viral genomic medicines include drug product identity confirmation, physical characterization, acceptance testing, stability studies, GMP release testing, toxicology testing and raw material testing.

 

Lipid Nanoparticles

 

  • Particle Size Distribution (PDI)
  • Osmolality
  • Zeta-Potential
  • pH
  • Encapsulation Efficiency
  • Total Drug Substance Content
  • In Vitro Potency

 

Lipids

 

  • Multi-Lipid Content
  • Multi-Lipid Identity/Integrity
  • Raw Material Testing
  • Stability/Forced Degradation
  • Residual Solvents
  • Solubility
  • Trace Impurity Analysis

 

Nucleic Acids

 

  • Capping Efficiency
  • PolyAdenylation
  • Residual DNA/Protein
  • dsRNA
  • Unnatural Ribonucleotides
  • Identify & Integrity 
  • Large RNA or saRNA Characterization

 

 

 

 

Analytical Instrumentation

Analytical instrumentation and technologies to assess drug substances and products include particle size analyzers, bioanalyzers, mass spectrometers, liquid chromatographic systems, cryogenic electron microscopes and flow cytometers.

 

Nanoparticles 


  • Dynamic Light Scattering (DLS) 
  • Osmometer 
  • Endotoxin* 
  • Bioburden* 
  • Cryo-TEM* 

 

 

 

 

Lipids

 

  • LC-MS/MS 
  • UHPLC-UV 
  • HPLC-ELSD 
  • UHPLC-CAD 

 

 

 

 

 

Payloads 

 

  • LC-MS/MS 
  • UHPLC-UV 
  • UHPLC-FLR 
  • CE-UV/LIF 
  • Bioanalyzer 

 

 

 

 

Bioassays 

 

  • Cytation 7 cell imaging multi-mode reader, Biospa, and MultiFlo Fx  
  • SDS-PAGE and Jess Automated Western blot  
  • Biotek plate readers (Colorimetric + Luminescence-based assays)  
  • Ella automated ELISA  
  • CytoFLEX Flow Cytometer  
  • RT-qPCR 

     

    *Available through third-party 

    Our Biopharmaceutical Services Team

    Experienced: Leverage comprehensive knowledge, insights and expertise in formulation development, process development, analytical development, quality, technology transfer and GMP manufacturing.

    Transparent: Prioritize direct communication and access to protocols and processes during the development of your drug product. 

    Integrated: Optimize the use of limited materials with NanoAssemblr and GenVoy technology platforms, enabling seamless scaling of drug products from preclinical to clinical development. 

    Flexible: Continue development and manufacturing through the late stages of drug development or transfer protocols to continue development in-house. 

    Streamlined: Collaborate across functional teams from proof-of-concept studies to cGMP manufacturing for Phase I and II clinical trials for an end-to-end workflow. 

    Drug Payloads, Drug Carriers and Research Applications

     

     

    Biopharmaceutical Services has broad technical expertise in payload design and lipid-based delivery systems, including lipid nanoparticle and lipopolymeric formulations, for a wide range of disease applications.

     

     

     

    Drug Payloads

    RNA Icon

     

    mRNA, siRNA, saRNA, Replicon RNA 

     

     

    pDNA Icon

     

    pDNA, dsDNA 

     

     

     

    Small Molecule Icon

     

    Small Molecule 

     

     

     

    Peptide icon

     

    Peptide 

     

     

     

    Virus icon

     

    Virus

     

     

     

    Drug Carriers

    LNP

     

    Lipid Nanoparticles

     

     

     

    LIPOSOME

     

    Liposomes

     

     

     

    POLYMER

     

    Polymer Nanoparticles

     

     

     

    EMULSION

     

    Emulsions

     

     

     

    Exosome

     

    Exosomes

     

     

     

    Research Applications 

    Vaccine icon

     

    Vaccine Development 

     

     

     

    Oncology icon

     

    Oncology 

     

     

     

    Liver Delivery

     

    Liver Delivery

     

     

     

    Cardiovascular Disease icon

     

    Cardiovascular Disease

     

     

     

    Lung Delivery icon

     

    Lung Delivery

     

     

     

    Partner with Biopharmaceutical Services
    Learn how our team can help accelerate your project
    Contact Us
    Clinical Partners
    evonik
    Ajinomoto-Bio-Pharma-Services
    ‹
    • "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
    ›

    Formulations Solutions Brochure
    Formulation Solutions BrochureRead more about Biopharmaceutical Services’ capabilities and offerings

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    Resource Center

    Webinar

    April 26, 2016

    Formulating Nanomedicines: Current Challenges and Solutions

    Read More 阅读更多

    Publication - Abstract

    December 16, 2020

    pharmaceutics

    Applying Microfluidics for the Production of the Cationic Liposome-Based Vaccine Adjuvant CAF09b

    S.T. Schmidt, D. Christensen and Y. Perrie

    Read More 阅读更多

    Webinar

    July 15, 2017

    Nanoparticle Manufacturing: Strategies for De-Risking Early Clinical Manufacture- Ray Lockard, Precision NanoS...

    Read More 阅读更多

    Publication - Abstract

    July 08, 2020

    Advanced Drug Delivery Reviews

    Liposomes: Advancements and Innovation in the Manufacturing Process

    S. Shah, V. Dhawan, R. Holm, M.S. Nagarsenker and Y. Perrie

    Read More 阅读更多

    Publication - Abstract

    December 05, 2018

    Journal of Drug Delivery Science and Technology

    Microfluidic Manufacturing Improves Polydispersity of Multicomponent Polymeric Nanoparticles

    K. Abstiens and A.M. Goepferich

    Read More 阅读更多

    Application Note

    March 15, 2022

    Genome Editing of Human Primary T Cells with Lipid Nanoparticles

    Read More 阅读更多 PDF
    Resource Center 资源中心