C014: GONAL-F Biosimilar Stable Cell Line (CHO)
The yield of GONAL-F biosimilar from the CHO stable cell line was above 100 mg/L.
PA000563-Mab-83300: α-HCG Monoclonal Antibody
Mouse Monoclonal Antibody;
Reactivity: Human;
Isotype: IgG1.PA000564-Mab-83400: β-HCG Monoclonal Antibody
Mouse Monoclonal Antibody;
Reactivity: Human;
Isotype: IgG1.BP000339-GD15: Recombinant Human Chorionic Gonadotropin (hCG)
Source: CHO-derived.
The hCG α/β activity was determined to be 25,000 IU/mg.
Purity > 97% by SDS-PAGE under reducing conditions and visualized by silver stain, and 97% by SEC-HPLC.BP000339-HOR-250: Human Chorionic Gonadotropin (hCG)
Source: Urine of pregnant women-derived.
The activity was found to be 6767 IU/mg.
Purity > 98%.C024: Luveris Biosimilar Stable Cell Line (CHO)
The yield of Luveris biosimilar from the CHO stable cell line was above 100 mg/L in flask.
C015: Ovidrel Biosimilar Stable Cell Line (CHO)
The yield of Ovidrel biosimilar from the CHO stable cell line was above 250 mg/L in a 15 liter manufacturing.
C015: Ovidrel Biosimilar Stable Cell Line (CHO)
The yield of Ovidrel biosimilar from the CHO stable cell line was above 250 mg/L in a 15 liter manufacturing.
Biologics production stable cell line development services utilize advanced technology platforms to generate cell lines expressing the target gene at very high levels for the manufacturing of recombinant proteins and antibodies.
- Performed under GLP; manufactured product may be used in FDA Nonclinical Laboratory Studies.
- Parental cell line is cGMP banked with certification.
- Set licensing fee arrangement for commercial production license.
- Cell lineage history of the cell line and testing details facilitate IND filing.C023: Thyrogen Biosimilar Stable Cell Line (CHO)
The yield of Thyrogen biosimilar from the CHO stable cell line was above 250 mg/L in flask.