Working closely with you, to ensure compliance with all regulatory requirements and to advise you in accordance with the product type, we offer cell and virus bank characterization services for research cell banks, master cell banks and working cell banks.
Services our biosafety team can offer
Microbial contaminants:
- Mycoplasma via culture and polymerase chain reaction (PCR) (USP 63 Phar.Eur.2.6.7)
- Mycobacteria via culture and validated quantitative polymerase chain reaction (qPCR)
- Spiroplasma
- Sterility (<USP 71>, Phar.Eur.2.6.12)
Adventitious virus detection
- In vitro cell culture assay
- 9CFR 113 in vitro cell culture assay and quantitative polymerase chain reaction (qPCR)
Specific virus detection:
- 300+ GMP validated virus specific quantitative polymerase chain reaction (qPCR) assays (USP <1126/1127>, Phar.Eur.2.6.21)
- Mouse antibody production (MAP)
- Hamster antibody production (HAP)
Identity and genetic stability testing:
- DNA fingerprinting identification of cell lines by random amplified polymorphic DNA (RAPD)
- Gene-specific nucleic acid testing (NAT) for identification
- Karyology for cell lines
- Plasmid and viral vector sequencing
- Vector and integrated expression cassette – gene copy number
- Southern Blot for genetic integrity
Retrovirus detection:
- Fluorescent product enhanced reverse transcriptase (F-PERT) and quantitative real time fluorescent product enhanced reverse transcriptase (Q-PERT)
- Transmission electron microscopy (TEM)
- Infectivity assays
- Infectious retroviruses/Mus-Dunni/HEK293 cocultivation
- Replication competent retrovirus
