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.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.
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.
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.
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.
PA007162.mm2c: In Vivo Grade Recombinant Murinized Anti-mouse PD-1 Mouse IgG2c-L234A L235A P329G (LALAPG) Kappa Monoclonal Antibody (Clone RMP1-14.1)
The in vivo grade recombinant murinized anti-mouse PD-1 / CD279 monoclonal antibody (mouse IgG2c-LALAPG kappa) was produced in mammalian cells.
Applications: immunohistochemistry (IHC), Flow Cytometry (FC), and various in vitro and in vivo functional assays.
Endotoxin Level: Less than 1 EU/mg of protein as determined by LAL method.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.
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.
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.