C016: NovoSeven Biosimilar Stable Cell Line (CHO)
The yield of NovoSeven biosimilar from the CHO stable cell line was above 30 mg/L in a 1000 liter manufacturing.
APIM050196: MGCD265 (GLESATINIB)
CAS No.: 936694-12-1.
Purity: 99% chemical purity (HPLC at 214 and 254 nm).
QC: HPLC-MS, 1HNMR and Quantitative Elemental Analysis.
Solubility: In DMSO.BP000176-GD19: Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Protein
Source: E. coli-derived.
The ED50 as determined by the dose-dependant stimulation of the proliferation of human TF-1 cells (human erythroleukemic indicator cell line) is less then 0.1 ng/ml, corresponding to a Specific Activity of 1.0 x 10^7 IU/mg.
Purity: > 95% by SEC-HPLC and reducing SDS-PAGE.
Endotoxin: < 0.01 ng/ug (0.1 IEU/ug).APIM050144: ERLOTINIB
CAS No.: 183321-74-6.
Purity: >99.5% (HPLC at 214 and 254 nm).
QC: HPLC, 1HNMR, and Quantitative Elemental Analysis.
Solubility: Soluble in DMSO and water.APIM050203: MOTESANIB (FREE BASE)
CAS No.: 453562-69-1.
Purity: > 99% (HPLC).
QC: LC/MS, 1HNMR.
Solubility: Soluble in DMSO.APIM050141: DEFACTINIB (VS-6063, PF-04554878)
CAS No.: 1073154-85-4.
Purity: >99% (HPLC at 214 and 254 nm).
QC: HPLC-MS, 1HNMR, and Quantitative Elemental Analysis.
Solubility: Soluble in DMSO.BP000134-GD21: Recombinant Human Interleukin-11 (IL-11) Protein
Source: P. Pichia-derived.
The ED50 as determined by the dose-dependant stimulation of the proliferation of murine 7TD1 was found to be less than 0.2 ng/ml, corresponding to a Specific Activity of 8.0 x 10^6 IU/mg.
Purity: > 95% by RP-HPLC and reducing SDS-PAGE.
Endotoxin: < 0.1 ng/ug (1 EU/ug).C013: Zaltrap / Eylea Biosimilar Stable Cell Line (CHO)
The yield of Zaltrap / Eylea biosimilar from the CHO stable cell line was above 2.1 g/L in a 3 liter manufacturing.
APIM050204: MOTESANIB DIPHOSPHATE
CAS No.: 857876-30-3.
Purity: > 99% (HPLC).
QC: LC/MS, 1HNMR.
Solubility: Soluble in water.APIM050132: CRENOLANIB
CAS No.: 670220-88-9.
Purity: >99.5% (HPLC).
QC: HPLC-MS, 1HNMR, and Quantitative Elemental Analysis.
Solubility: Soluble in DMSO, and water with 1 eq. of acid.