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.C001: Avastin Biosimilar Stable Cell Line (CHO)
The yield of Avastin biosimilar from the CHO stable cell line was above 1.7 g/L in a 750 liter manufacturing.
C005: Lucentis Biosimilar Cell Line (E. coli)
The yield of Lucentis biosimilar from E.coli was above 36 mg/L in a 7.5 liter manufacturing.
C001P: Bevacizumab Biosimilar, Human VEGF Monoclonal Antibody
Recombinant Humanized IgG1 Monoclonal Antibody generated from the same parent mouse antibody as ranibizumab.
Specificity/Sensitivity: The monoclonal antibody bevacizumab biosimilar specifically binds to the human VEGF-A.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by bevacizumab.C005P: Ranibizumab Biosimilar, Human VEGF Monoclonal Antibody Fragment (Fab)
Recombinant Humanized Monoclonal Antibody Fragment (Fab) generated from the same parent mouse antibody as bevacizumab.
Specificity/Sensitivity: The research grade Fab protein ranibizumab specifically binds to the human VEGF-A.
Applications: Functional assay, neutralization.