Case study: manufacturing a 293 cell bank

Lead time: 9 months, including quality testing (varies with project scope)

Pilot manufacturing (non-GMP)
Following the acceptance test, we expand the cells at a small scale and then at full scale to confirm the manufacturing process. We confirm the cell proliferation profile.

• Sterility
• Mycoplasma (culture isolation and DNA staining methods)
• In vitro virus testing
• In vivo virus testing
• Transmission electron microscopy assay
• Reverse transcriptase assay (F-PERT)
• Infectious retrovirus
• Adenovirus
• Adeno-associated virus
• Human viruses
• Bovine and porcine viruses
• Cell viability assays
• Cell identification (RAPD-PCR)

Case study: manufacturing an E. coli cell bank

Lead time: 6 months, including quality testing (varies with project scope)

  Pilot manufacturing (non-GMP)
Following the acceptance test, we expand the cells on a small scale. We confirm the cell proliferation profile and quality.

  Manufacturing under GMP conditions
We manufacture the cell bank in our GMP facility, and then deliver manufacturing plans, documents and reports, and ~150 vials of cell bank.

  Quality testing

• Colony formation
• Auxotrophy
• Biochemical assays
• Microbial enumeration
• Plasmid retention rate
• Vector copy number
• Restriction enzyme digestion
• Plasmid sequencing
• Lysogeny
• Phenotype (UV sensitivity, antibiotic resistance, etc.)
• Test production (flask culture)