SunBio

SunBioGMP

Capability

Technology Presentation

2003

SunBio GMP OverviewSunBio 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.

SunBio GMP Pilot PlantSunBio GMP Pilot Plant

<Specifications of GMP Pilot Plant>

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

Yuhan GMP BuildingsYuhan GMP Buildings

SunBio GMP Pilot PlantSunBio GMP Pilot Plant

GMP Analytical CapabilityGMP Analytical Capability

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-803HQShodex 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

Certificate of AnalysisCertificate of Analysis

Parameter Instrument Specification Result

Molecular Weight (Mw)

MALDI-TOF 20,000 +/- 2,000 20,575

Purity (Functional Activity)

NMR >90% 95%

Polydispersity GPCMALDI-TOF

<1.1<1.1

1.081.01

Main Peak Fraction

GPC >90% 97%

Diol Content GPCNMR

<2%<2%

Undetectable1%

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