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Stable Cell Line Development Service for Biologics Production
DNA vectors used in this stable cell line generation service will NOT be transferred to clients under this arrangement.
We offer custom services for development of stable cell lines that express recombinant proteins and antibodies at high levels. Production yield of recombinant antibodies can be greater than 2 gram per liter.
Use of our streamlined cell culture platform processes, including standardized process conditions and procedures, helps product candidates move forward from the research cell line phase to the master cell bank optimization phase for manufacturing. We perform high throughput clone screening to derive the best production clone at an early stage of cell line development, and utilizes single-use bioreactors to predict large-scale production performance.
- 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.
Syd Labs has developed more than 20 antibody and protein biosimilar stable cell lines including:
Erbitux Biosimilar Stable Cell Line (HER1, ErbB-1, EGFR) (>1.7 g/L in a 750 liter manufacturing)
Herceptin Biosimilar Stable Cell Line (HER2, ErbB-2, c-neu) (>1.5 g/L in a 3 liter manufacturing)
Avastin Biosimilar Stable Cell Line (VEGF-A) (>2.0 g/L in a 750 liter manufacturing)
Rituxan Biosimilar Stable Cell Line (CD20) (>1.8 g/L in a 3 liter manufacturing)
Humira Biosimilar Stable Cell Line (TNF) (>2.0 g/L in a 50 liter manufacturing)
NovoSeven Biosimilar Stable Cell Line (Factor VIIa) (>30 mg/L in a 1000 liter manufacturing)
GONAL F Biosimilar Stable Cell Line (follicle-stimulating hormone, FSH) (>750 mg/L in a 15 liter manufacturing)
Ovidrel Biosimilar Stable Cell Line (human chorionic gonadotropin, hCG) (>250 mg/L in a 15 liter manufacturing)
Syd Labs also provides the following stable cell line generation services:
Stable Cell Line Development Services for Antibody Production: development of stable cell lines for recombinant antibody expression.
Stable Cell Line Development Services for Protein Production: development of stable cell lines for recombinant protein expression.
Standard Stable Cell Line Development Services: non-viral generation of adhension or suspension stable cell lines with one or two gene insertion.
Lentiviral Based Stable Cell Line Generation Services: development of stable cell lines using lentivirus.