Sun. Bio 2003 Technology Presentation Sun. Bio GMP Capability
Sun. Bio GMP Overview • Sun. Bio 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. • Sun. Bio 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. • Sun. Bio is currently supplying GMP PEG derivatives to US biotech companies.
Sun. Bio GMP Pilot Plant <Specifications of GMP Pilot Plant> Manufacturer Buchi AG (Swiss) Model Chem. Reactor CR 60 Type Glass Reactor Vessel Volume 50 L Operating Temperature -20 ~ 200 C Vacuum Full Vacuum Operating Pressure 0. 4 Bar
Yuhan GMP Buildings
Sun. Bio GMP Pilot Plant
GMP Analytical Capability FT-NMR 400 Measurable Nuclei 1 H, 13 C Manufacturer JASCO (Japan) Model FT-IR 460 Plus Interferometer Michelson Type Spectral Range 7800 to 380 /cm Pump Bio. Rad 1350 Column Shodex OH pak SB-803 HQ Shodex OH pak SB-802. 5 HQ Detector MALDI-TOF Mass JNM-AL 400 MHz GPC JEOL (Japan) Model FT-IR Manufacturer RI (Lab Alliance 2000 F) Manufacturer Applied Biosystems Model Voyager-DE STR Mass Range >300, 000 Da Laser > Nitrogen, 337 nm, 3 ns pulse
Certificate of Analysis Parameter Instrument Specification Result Molecular Weight (Mw) MALDI-TOF 20, 000 +/- 2, 000 20, 575 Purity (Functional Activity) NMR >90% 95% Polydispersity GPC MALDI-TOF <1. 1 1. 08 1. 01 Main Peak Fraction GPC >90% 97% Diol Content GPC NMR <2% Undetectable 1% Water Content Karl Fisher Method <1% 0. 5% Impurities NMR <10% 5% Volatile Organic Compounds GC <100 ppm <10 ppm Color Visual White to slight yellow pass Endotoxin Level LAL Assay <0. 6 EU pass
Скачать презентацию Sun Bio 2003 Technology Presentation Sun Bio GMP
93d05fdc544e977314fff1f6b19cedfc.ppt