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.C002: Erbitux Biosimilar Stable Cell Line (CHO)
The yield of Erbitux biosimilar from the CHO stable cell line was above 1.7 g/L in a 750 liter manufacturing.
C006: Perjeta / Omnitarg Biosimilar Stable Cell Line (CHO)
The yield of Perjeta / Omnitarg biosimilar from the CHO stable cell line was above 3.0 g/L in a 3 liter manufacturing.
C009: Herceptin Biosimilar Stable Cell Line (CHO)
The yield of Herceptin biosimilar from the CHO stable cell line was above 2.0 g/L in a 3 liter manufacturing.
C012: Vectibix Biosimilar Stable Cell Line (CHO)
The yield of Vectibix biosimilar from the CHO stable cell line was above 2.0 g/L in a 3 liter manufacturing.
C002P: Cetuximab Biosimilar, Human EGFR Monoclonal Antibody
Recombinant Chimeric IgG1 Monoclonal Antibody.
Specificity/Sensitivity: The monoclonal antibody cetuximab biosimilar specifically binds to the human EGFR.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by cetuximab.C006P: Pertuzumab Biosimilar, Human HER2 Monoclonal Antibody
Recombinant Humanized IgG1 Monoclonal Antibody.
Specificity/Sensitivity: The monoclonal antibody pertuzumab biosimilar specifically binds to the human HER2/ErbB-2/c-neu.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by pertuzumab.C009P: Trastuzumab Biosimilar, HER2/ErbB-2/c-neu Monoclonal Antibody
Recombinant Humanized IgG1 Monoclonal Antibody.
Specificity/Sensitivity: The monoclonal antibody trastuzumab biosimilar specifically binds to the human HER2 / ErbB-2 / c-neu.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by trastuzumab.C012P: Panitumumab Biosimilar, Human EGFR/ErbB-1/HER1 Monoclonal Antibody
Recombinant Humanized IgG2 Monoclonal Antibody.
Specificity/Sensitivity: The monoclonal antibody panitumumab biosimilar specifically binds to the human EGFR, ErbB-1 and HER1.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by panitumumab.