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.
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.
Clinical Stage Programs
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.
Technology Transfer & Manufacturing
Chemistry Manufacturing & Controls (CMC) Support
Bioassay Development and Screening
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 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.
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.
*Available through third-party
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.
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.
mRNA, siRNA, saRNA, Replicon RNA
Publication - Abstract
July 01, 2020
Journal of Controlled Release
June 11, 2018
Publication - Summary
May 17, 2019
January 02, 2018
September 14, 2016