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To use
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- Optimized glycosylation without compromising other CQAs or product yield.
- Improved lot-to-lot consistency to reduce risk of product quality variation and resulting delays.
- Generation of glycoprofiles which may not otherwise be generated.
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Appearance: Clear and colorless to slightly yellowish solution
Specific activity: ≥400 U/μg
Protein (OD 280 nm) A280 = 1.931: 15 ± 1.5 mg/mL
Purity (HPLC): >90%
Bioburden: ≤100 CFU/mL
Endotoxin: ≤10 EU/mg
Host cell protein: ≤ 4000 ppm
Host cell DNA: ≤ 100 pg/mg
Heavy metal (Cd, Co, V, Ni, Ag, Se): ≤ 10 ppmStability: At –15 to –25°C within specification range for 18 months (08 098 174 103) and 12 months (08 098 174 101).",
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