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Lipid Nanoparticles

Next-generation drug delivery fine-tuned for improved efficacy and safety

Illustration of a lipid nanoparticle LNP.

Overview

Fujifilm’s longstanding expertise in fine chemistry, synthesis and production technologies can be fully utilized in the field of lipid nanoparticles (LNP). Our outstanding team of synthetic chemists has developed a proprietary library of ionizable lipids—essential LNP components directly related to safety and efficacy—for partners in search of advanced LNP formulations. Experienced formulation and analytical scientists can provide early-stage lipid-based formulation development, manufacturing scale-up, and quality assessment development.

Fujifilm’s LNP CDMO service provides end-to-end GMP operations for mRNA production, LNP formulation, and fill-finish at a single-location site in Toyama, Japan. This one-stop CDMO service provides start-up companies and other R&D organizations with a fast and low-risk CMC development timetable.

We look forward to collaborating with LNP development partners around the world.

LNP Formulation

Fujifilm’s “one-stop” service supports customers with LNP formulation development, optimization, and manufacturing, from discovery to commercialization phases:

Seamless scale-up manufacturing using NanoAssemblr® microfluidic technology — supported by Precision NanoSystems through a strategic alliance — results in demonstrated consistent particle size and high mRNA encapsulation rates at small laboratory to commercial GMP production scales.

Fujifilm operates a wide range of NanoAssemblr® microfluidic mixers for LNP manufacturing, providing production services from the 1 to15 mL benchtop scale for discovery studies and 10-1000 mL scale for preclinical phase to GMP production of 100 L or above.
A scale-up study shows that LNPs with particle sizes as small as approximately 80 nm and high encapsulation rates of mRNA can be prepared from small to large scales.
A scale-up study shows that LNPs with particle sizes as small as approximately 80 nm and high encapsulation rates of mRNA can be prepared from small to large scales.
Fujifilm’s proprietary ionizable lipids are amphiphilic molecules with a polar diamine head group, a hydrophobic tail region, and a biodegradable linker between the two. Mixing and matching these different components can fine-tune the lipophilicity, bulkiness, and pKa of the nanoparticle.

Formulation development service with proprietary ionizable lipids

Access to formulation expertise and a well-characterized ionizable lipid library can streamline drug development.

LNP components can be mixed and matched during formulation and optimization to improve target specificity and drug efficacy.

Fujifilm has designed and characterized over 500 compounds, many of which exceed mRNA delivery benchmarks. Learn more about Fujifilm’s CDMO services for LNP formulation development using proprietary ionizable lipids.

Partner with Fujifilm to access our proprietary ionizable lipid library and fast-track scalable drug candidate development.

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Fujifilm has identified novel ionizable lipids through in vivo screening of over 500 compounds, of which more than 30% exceed the mRNA delivery benchmark.
701 Factory at Toyama site in Japan is an essential component to Fujifilm’s LNP GMP Manufacturing.

LNP GMP Manufacturing

Fujifilm’s nanoparticle formulation production facility — Plant 701 at the Toyama site — is equipped with a microfluidic mixer for LNP particle production, a tangential flow filtration system (TFF) for buffer exchange, and aseptic filtration process and filling line.

  • Compliant with US, EU, and JP GMP guidelines
  • Upstream: LNP / Liposome NxGenTM Microfluidic mixer (0.2 – 100 L)
  • Downstream: Kros Flo® TFF systems and Mobius Flex Ready®  (mL to ~100 L scale)
  • Vial filling system in an isolator (3000 vials/h)
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LNP Analytical Services

Fujifilm’s experienced analytical chemists provide LNP-specific analytical method development services for LNP batch analyses:

  • Particle size and distribution
  • Zeta potential, pH, osmolality
  • Lipid & API analysis by HPLC (UV, CAD, TripleQ MS, TOF MS)
  • Residual solvent analysis by GC (FID)
  • Ion analysis (IC)
  • Metal analysis (ICP-MS)
  • Spectroscopy (UV, IR, Fluorescence, NMR)
  • Particulate matter (Accusizer®)
  • Non-GMP cryo-TEM imaging
  • Sterility and endotoxin testing
  • Karl Fischer, polarimeter
  • Capillary electrophoresis
  • Fluorescence/UV microplate reader
  • Sanger sequencer

 

Contact

Have questions about our research or services? Visit our contact page to connect with our experts.

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