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.C010: Rituxan Biosimilar Stable Cell Line (CHO)
The yield of Rituxan biosimilar from the CHO stable cell line was above 1.8 g/L in a 3 liter manufacturing.
C010P: Rituximab Biosimilar, CD20 Monoclonal Antibody
Recombinant Humanized IgG1 Monoclonal Antibody.
Specificity/Sensitivity: The monoclonal antibody rituximab biosimilar specifically binds to the human TNF alpha.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by rituximab.