BioPharma

Services

Precision NanoSystems’ BioPharma Services accelerates the development of mRNA-lipid nanoparticle (LNP) formulations to create genomic medicines by using NanoAssemblr® instruments, ionizable lipids and off-the-shelf reagents offering, end-to-end LNP Formulation Services and technology transfer of manufacturing processes for cGMP production. 

Leverage Deep Expertise to Expedite Preclinical and Clinical RNA-LNP Manufacturing

Accelerate formulation development, optimization, and process scale-up by collaborating with our BioPharma Services team that includes payload design, analytical development services, quality control and quality assay (QA/QC) services. If you are looking for a reliable CDMO partner, our contract services team is here to deliver customized solutions for successful LNP drug manufacturing.

Our experienced team of scientists specializes in optimizing the use of limited materials in scaling drug products from discovery to cGMP manufacturing for a broad range of drug carriers such as Lipid Nanoparticles, Liposomes, and Polymeric Nanoparticles (poly(lactic-co-glycolic acid) PLGA). We have the expertise in handling a wide range of drug payloads, including mRNA, siRNA, saRNA, Replicon RNA, Peptides, Small Molecules, and Viruses with the NanoAssemblr® and GenVoy™ technology platforms. Collaborate with us to develop a comprehensive project plan with customized milestones, deliverables, timeline and budget that aligns with your goals.

Clinical Stage Programs

>44

GMP Batches

Approved Drugs

*Precision NanoSystem’s BioPharma 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.

Get in Touch with an Expert

Complete Solutions for Every Step of Pharmaceutical Development

Partner with BioPharma 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.

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

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

Screening Icon

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

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, BioPharma 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 BioPharma 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

BioPharma 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 BioPharma Services

Learn how our team can help accelerate your project

Clinical Partners

‹

"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

›

BioPharma Services Brochure

Read more about BioPharma Services’ capabilities and offerings

Download Brochure

Resource Center

Publication - Abstract

May 31, 2019

Vaccine

mRNA Vaccines Against H10N8 and H7N9 Influenza Viruses of Pandemic Potential Are Immunogenic and Well Tolerate...

R.A. Feldman, R. Fuhr, I. Smolenov, A. Ribeiro, L. Panther, M. Watson, J.J. Senn, M. Smith...

Read More 阅读更多

Video

August 04, 2017

Seamless Development of Nano-Sized Delivery Systems for Lipophilic Drugs

Read More 阅读更多

Poster

November 09, 2021

Novel Lipid Nanoparticle Delivery Reagent and Rapid Manufacturing Workflow to Accelerate Preclinical Developme...

PTCD1 is Required for Mitochondrial Oxidative-phosphorylation: Possible Genetic Association with Alzheimer's D...

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

Read More 阅读更多

Publication - Summary

February 27, 2018

Cell Reports

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

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

Read More 阅读更多

Video

August 10, 2017

Nanoparticle Manufacturing – Strategies for De-Risking Early Clinical Manufacture | Ray Lockard

Read More 阅读更多

Resource Center 资源中心