GMP Manufacturing
One operation—from mRNA manufacturing to fill/finish—coordinated by a single project management team
Overview
Fujifilm operates as a one-stop mRNA-to-LNP CDMO service provider, offering in vitro transcription (IVT) to LNP fill-finish production. Fujifilm also offers one-stop development and manufacturing support for small molecule liposomes, from formulation development to GMP manufacturing.
Laboratories and factories for mRNA and LNP production at our single campus in Toyama, Japan, are operated in a fully integrated fashion, closely linked and controlled by a single project management unit to mitigate logistical risks and shorten turnaround times.
701 Factory at Toyama site in Japan
Products: LNP and liposomal products
Total floor space: 3,359 m2
Construction completed: December 2019
GMP Manufacturing
Fujifilm’s 701 factory is a GMP-compliant manufacturing plant exclusively focused on the sterile production of liposome and LNP formulations. It has an isolated compounding room dedicated to handling highly potent APIs. In addition to microfluidic mixers for LNP and a high-speed stirring dispersion system for liposome particle preparation, the facility is equipped with tangential flow filtration (TFF), a sterile filtration system, and a vial filling machine in an isolator.
Our GMP facility offers:
- GMP production of LNPs and liposomes
- 35-L and 350-L scale liposome manufacturing equipment
- Highly potent APIs handling area
- NanoAssembler IgniteTM, BlazeTM, and GMP range of microfluidic mixers for LNP manufacturing, from benchtop to commercial scale GMP production.
- Kros Flo® TFF and Mobius Flex Ready® systems for mL to 100-L production scales.
- Aseptic vial filling system
- Filling Speed: 50 vials/min (3,000 vials/h）
- Vial Size: ISO 2R, 4R, 6R, 10R, 20R
- Filling Amounts: 0.5 mL – 20 mL
- Washing and sterilization of empty vials
- Vial filling and rubber stopper
- External wash of filled vials
- Vial accumulator
*Millipore Logo and Mobius are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.
**Made by Shibuya Corporation
Liposome Manufacturing
Our proprietary high-speed stirring liposome dispersion method produces homogeneous liposome particles with a sharp size distribution. This process allows for production scale-up and has good repeatability.
mRNA Manufacturing and Encapsulation
Fujifilm carries out mRNA IVT to LNP fill-finish production at its campus in Toyama, Japan, where mRNA and LNP production, scale-up, and analysis are operated in a fully integrated fashion to provide a one-stop mRNA-LNP CDMO service.
LNP Manufacturing
Fujifilm offers seamless scale-up LNP manufacturing using the NanoAssemblr® microfluidics system, providing LNP manufacturing services with demonstrated small, consistent particle size and high mRNA encapsulation rates at small laboratory to commercial GMP production scales.
GMP Batch Release
Our team of analytical chemists experienced in LNPs and liposome analytical method development and analytical equipment enable LNP batch release 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
- Spectroscopy (UV, IR, Fluorescence, NMR)
- Particulate matter (Accusizer®)
- Sterility and endotoxin testing
- Karl Fischer, polarimeter
- Capillary electrophoresis
- Fluorescence/UV microplate reader
- Sanger sequencer