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 cGMP manufacturing. 

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 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

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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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GMP Manufacturing

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, 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, 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

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