Cell Storage Services (Cryostorage)
SDIX provides a safe and reliable high capacity storage for all of your cell lines and dual site storage for all Master Cell Banks. As your primary site storage facility for Master Cell Banks, the vials will be divided and maintained at two locations. Liquid nitrogen freezers provides secure storage environment.
- Automated cryogenic refrigeration equipment
- All unit contain local and remote alarm systems
- Cell lines are maintained at -150ºC or less
- Restricted access to freezers
- Electronic inventory system, with dual verification
Cell Banking
A cell bank provides a stable uniform source of hybridoma cells for monoclonal antibody production. Your cell line is used for generation of a Platinum Master Cell Bank or a Gold Master Cell Bank and a Manufacturer’s Working Cell Bank. Before freezing the cell bank, the clonality of the cell line is determined and the isotype and isoelectric point of the monoclonal antibody is determined.
After the cell bank is frozen, cryovials are thawed and the same tests are performed on the cells in the post-freeze culture and the monoclonal antibody. When post freeze is completed, the cell bank undergoes mycoplasma and sterility testing.
Master Cell Bank – Platinum
- Freeze 50 vials. Viability tested at 0, 24, and 48 hours. Isotype confirmed.
- Sample sent for mycoplasma safety testing
- LDC is performed and 4 highest producing clones are selected by Isotype specific ELISA. Expanded and Ab concentration is tested by RID
- Clone with highest Ab concentration is selected and an additional LDC is performed to confirm clonality of greater than 85% prior to freezing down the bank
- Quality Check – Viability, Clonality, Sterility, Pre/Post IEF, Biological (21 agents)
- MCB Report
- One year free dual site storage at the Delaware and Maine sites (70/30 split)
Master Cell Bank – Gold
- Freeze 50 vials. Viability tested at 0, 24, and 48 hours. Isotype confirmed.
- Sample sent for mycoplasma safety testing
- LDC is performed and 4 highest producing clones are selected by Isotype specific ELISA. Expanded and Ab concentration is tested by RID
- Clone with highest Ab concentration is selected and an additional LDC is performed to confirm clonality of greater than 85% prior to freezing down the bank
- Quality Check – Viability, Clonality, Sterility, Pre/Post IEF, Biological (9 agents)
- MCB Report
- One year free dual site storage at the Delaware and Maine sites (70/30 split)
Research Cell Bank
- Viability tested at 0, 24, and 48 hours. Isotype confirmed
- Samples sent for mycoplasma safety testing
- Freeze 20 vials
- Biological Testing (9 agents)
- One year of free storage at the Delaware site
Manufacturer’s Working Cell Bank
- Starting vial must be from an SDIX generated Master Cell Bank
- Viability tested at 0, 24 and 48 hours. Isotype confirmed.
- Limited dilution cloning is performed to confirm > 85% clonality prior to freezing the bank.
- Freeze 25 vials
- Perform post thaw with 1 vial testing; viability, isotype and limited dilution cloning on frozen cells. Verify antibody banding properties by isoelectric focusing.
- Manufacturer’s Working Cell Bank Report is generated.
- Includes one year free storage at the Newark, DE site
