Facilities

Features of YBIRD

YBIRD consists of the GMP controlled facility (745m²) and the Manufacturing Technology Research Laboratory(MTRL)(130m²). The GMP controlled facility is a pilot-scale manufacturing facility for manufacturing of non-sterile investigational drug substances. We also run non-GMP grade pilot-scale manufacturing. Process development, bench-scale sample preparation, and any other bench-scale experiments are performed in MTRL. We handle mammalian cells and microbial cells in separated areas to protect contamination both in the GMP controlled facility and in MTRL.

Special
feature

manufacturing of recombinant proteins both with mammalian cells and with microbial cells

Special feature

In the GMP controlled facility, cross contamination risks are minimized by separating the two areas by the waste transfer hallway, non-sharing apparatuses in both upstream and downstream processes, and controlling air current.

Special
feature

maximum culture volume is 200L for microbial cell lines, 500L for mammalian cell lines

Special feature

In the GMP controlled facility, the maximum working culture volume is 200L for microbial cell lines with a stainless-steel bioreactor, and 500L for mammalian cell lines with a single-use bioreactor.

Special
feature

Reduction of cleaning validation
burden

In the GMP controlled facility, all tanks except the microbial bioreactors are single-use types. Adoption of single-use tanks for media/ buffer preparation and mammalian cell culture reduces cross contamination risks, resulting in the reduction of cleaning validation burden.

Special feature

Details of the facilities

GMP controlled facility

Each operational room is in both microbial and mammalian cell areas arranged simply in the order of actual process, that is, starting with media/ buffer preparation room, culture room, purification room and a filling room (only the filling room is shared but not-simultaneously used).

In the microbial culture room, a bioreactor, disk type continuous centrifuge, and high pressure homogenizer (French press) are connected as a series to build a system that enables cleaning and sterilization of all connected apparatuses after use by the CIP and SIP program.
In the mammalian cell culture room, all bioreactors are single-use bag types. Culture in 0.1~25L volume range is run by a WAVE bioreactor, and cultures in 50L~100L volume range and 250~500L volume range are run by tank type bioreactors. The WAVE bioreactor is compatible with perfusion culture.

In either area, GE Healthcare’s AKTAplilot system is furnished for automated protein purification. The glass columns for chromatography with diameter of 10cm, 20cm, and 30cm are available. chromatography chambers and mobile chiller-jacketed buffer tanks are also available in the case of low temperature purification.

Filling drug substances is implemented in the bio-clean bench(class 100, inside) set up in the class 100,000 clean room. The filling process is mannually operated bulk filling.

Quality control room is in the uncontrolled air conditioning area where we use spectrophotometers, electrophoreisis apparatuses, HPLC, and UPLC for analyses.

Floor plan of GMP controlled facility

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A floor plan of GMP controlled area

Area for mammalian cells

Area for microbial cells

Main facilities

Fermentation

Area for mammalian cells

  • CO2 incubator
  • Bioreactor 0.1~25L, 50~100L, 250~500L
    (electrically driven bioreactor, single-use bag type)
  • Membrane filtration system

Area for microbial cells

  • Shaking incubator
  • Bioreactor: 300L (working volume: 200L)
  • High-pressure homogenizer
  • Continuous centrifuge

Purification

Area for mammalian cells and microbial cells (nonshared)

  • Chromatography chamber
  • Purification equipment (AKTA Pilot)
  • Column for purification (3 types)
  • Virus removal apparatus

Filling

Common area (nonsimultaneous use)

  • clean bench

Others

  • Water and Steam: Facility to make water for injection, Pure steam generator
  • Air conditioning facility: Controlled HEPA filter, Temperature, Humidity, Atmospheric pressure in room and Cleanliness
  • Analytical apparatus for Quality Control

Manufacturing Technology Research Laboratory (Non GMP controlled area)

Production technology laboratory (Non GMP controlled area)

Manufacturing Technology Research Laboratory is a P2 level lab, which consists microbial cell area, mammalian cell area, and an anteroom between them.

Have we do process development including small scale culturing and purification using a single-use small shaking bioreactor, parallel bioreactor systems, and medium pressure chromatograph systems.