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 design a payload based on your target gene of interest and develop the formulation, processes, analytics and manufacturing protocols for preclinical to clinical drug development. Our 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.

Clinical Stage Programs

>44

GMP Batches

Approved Drugs

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.

Screening Icon

Screening

Identify and validate drug targets in vitro

Formulation Development Icon

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

Scale Up Icon

Scale-Up

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

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Tech Transfer Icon

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

Analytical Services Icon

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 both viral and 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
Pharmacokinetic/ADME Studies

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

Viral Vectors

Viral Sizing & Polydispersity
Total Genomic DNA
Viral Titre
Capsid Protein Analysis
AAV Chromatographic Separation
BSC2 Handling & Formulation
Empty/Filled Analysis

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
SDS-PAGE & Automated Western Blot
ELISA Plate Readers
Flow Cytometry
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

Cardiovascular Disease icon

Cardiovascular Disease

Lung Delivery icon

Lung Delivery

Partner with Biopharmaceutical Services

Learn how our team can help accelerate your project

Clinical Partners

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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

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Formulations Solutions Brochure

Read more about Biopharmaceutical Services’ capabilities and offerings

Download Brochure

Resource Center

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

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Publication - Abstract

October 01, 2020

Viral Immunology

Coronavirus Disease 2019 Vaccine Development: An Overview

R. Sumirtanurdin and M.I. Barliana

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Webinar

July 15, 2017

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

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Poster

September 20, 2021

Scale Up and Manufacturing of Self-amplifying RNA-LNPs for a COVID-19 Vaccine Using the NanoAssemblr® GMP Syst...

A Scalable Microfluidics Platform for the Development of Nanoparticles

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

R. Jain, J.P. Frederick, E.Y. Huang, K.E. Burke, D.M. Mauger, E.A. Andrianova, S.J. Farlow...

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Resource Center 资源中心

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