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SunBio

SunBio. Technology Presentation. SunBio GMP Capability. 2003. SunBio GMP Overview. SunBio operates a GMP pilot plant inside GMP Building A of Yuhan Chemical Company. Yuhan is US FDA audited and approved. The latest FDA inspection of 2002 was successful.

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SunBio

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  1. SunBio Technology Presentation SunBio GMP Capability 2003

  2. SunBio GMP Overview • SunBio operates a GMP pilot plant inside GMP Building A of Yuhan Chemical Company. • Yuhan is US FDA audited and approved. The latest FDA inspection of 2002 was successful. • Yuhan has been audited by GSK, Schering Plough, Wyeth, Gilead. • SunBio GMP pilot plant can produce up to 10 kg per batch of PEG derivatives per week. This pilot plant is dedicated to manufacturing of PEG derivatives only. The pilot plant is housed in a room where no other manufacturing takes place. This room is under an independent air handling system. • For larger manufacturing capacity, Yuhan’s 1-3 ton batches are available. • SunBio is currently supplying GMP PEG derivatives to US biotech companies.

  3. Manufacturer Buchi AG (Swiss) Model ChemReactor CR 60 Type Glass Reactor Vessel Volume 50 L Operating Temperature -20 ~ 200 C Vacuum Full Vacuum Operating Pressure 0.4 Bar SunBio GMP Pilot Plant <Specifications of GMP Pilot Plant>

  4. Yuhan GMP Buildings

  5. SunBio GMP Pilot Plant

  6. FT-NMR Manufacturer JEOL (Japan) Model JNM-AL 400 MHz 400 Measurable Nuclei 1H, 13C FT-IR Manufacturer JASCO (Japan) Model FT-IR 460 Plus Interferometer Michelson Type Spectral Range 7800 to 380 /cm GPC Pump BioRad 1350 Column Shodex OH pak SB-803HQ Shodex OH pak SB-802.5HQ Detector RI (Lab Alliance 2000F) MALDI-TOF Mass Manufacturer Applied Biosystems Model Voyager-DE STR Mass Range >300,000 Da Laser > Nitrogen, 337 nm, 3ns pulse GMP Analytical Capability

  7. Certificate of Analysis

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