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To use in vitro glycoengineering in drug development and manufacturing processes, enzymes should be of enhanced quality (EQ), compared to enzymes used in early R&D or analytical applications: Enzymes should be tested for host-cell impurities and relevant metal impurities and be available at least in gram amounts . α-2,6-Sialyltansferase, rec. EQ fulfills those criteria and can also be provided in GMP Grade upon request.",
"Country": "XG",
"Code": "Product Description",
"Name": "Product Description"
},
{
"Language": "en",
"Value": "Incubation of α-2,6-Sialyltansferase and CMP-NANA with a glycoprotein leads to increased sialylation of the glycoprotein.
As α-2,6-Sialyltansferase rec. EQ adds sialic acid only to galactosylated glycostructures, a galactosylation of the glycoprotein in a previous step helps to achieve higher sialylation levels. Galactosylation can be achieved by incubation of the target protein with ß-1,4-Galactosyltransferase and UDP-Galactose.",
"Country": "XG",
"Code": "Applications",
"Name": "Applications"
},
{
"Language": "en",
"Value": "α-2,6-Sialyltransferase, rec. EQ can be used for in vitro glycoengineering of glycoproteins, e.g. therapeutic proteins, in drug development and manufacturing.",
"Country": "XG",
"Code": "Positioning",
"Name": "Positioning"
},
{
"Language": "en",
"Value": "Benefits of using in vitro glycoengineering to modify glycosylation of therapeutic proteins:
Time- and cost-saving generation of glycan variants to facilitate drug development.
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.
Streamlined analytics in comparability studies.
",
"Country": "XG",
"Code": "Benefits",
"Name": "Benefits"
},
{
"Language": "en",
"Value": "No animal-derived material is added in fermentation, purification, and final formulation of this enzyme.",
"Country": "XG",
"Code": "Quality Control",
"Name": "Quality Control"
},
{
"Language": "en",
"Value": "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 ppm Stability: At –15 to –25°C within specification range for 18 months (08 098 174 103) and 12 months (08 098 174 101).",
"Country": "XG",
"Code": "Specification",
"Name": "Specification"
}
]
}
}
]
}
