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.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.
C017: ReFacto Biosimilar Stable Cell Line (CHO)
The yield of ReFacto biosimilar from the CHO stable cell line was above 60 IU/mL in a 50 liter manufacturing.
C018: Advate / Kogenate Biosimilar Stable Cell Line
The yield of Advate / Kogenate Biosimilar from the CHO stable cell line was above 60 IU/ml in a 50 liter manufacturing.
C019: BeneFIX Biosimilar Stable Cell Line (CHO)
The yield of BeneFIX biosimilar from the CHO stable cell line was above 20 IU/mL in a 15 liter manufacturing.
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.
C017: ReFacto Biosimilar Stable Cell Line (CHO)
The yield of ReFacto biosimilar from the CHO stable cell line was above 60 IU/mL in a 50 liter manufacturing.
C018: Advate / Kogenate Biosimilar Stable Cell Line
The yield of Advate / Kogenate Biosimilar from the CHO stable cell line was above 60 IU/ml in a 50 liter manufacturing.
C019P: BeneFIX Biosimilar, Recombinant Factor IX
The yield of BeneFIX biosimilar from the CHO stable cell line was above 20 IU/mL in a 15 liter manufacturing.