Cell Bank Sterility
Sterility testing determines the presence of general and specific contaminants in cell lines, in order to ensure the safety of clients’ biological products. For sterility and for the presence of
- Microbial Testing
- Mycoplasma detection (DNA fluorochrome and direct inoculation methods)
- Mycoplasma detection by PCR
- Sterility (21 CFR/USP/EP/JP)
- Bacteriostasis and Fungistasis (B&F)
- PCR
- Biochemical: Isoenzyme analysis (human origin)
- Other: TEM
- Animal-Derived Materials
- Adventitious agents
- Retrovirus infectivity assay
- Replication Competent Adenovirus (RCA) Assay
- Vaccine Testing
- Bulk Harvest/In-Process Samples
- Cross-reactivity testing
- Custom Assays
- Endotoxin testing
- Virucidal and antimicrobial efficacy studies
- Environmental monitoring
- Package stability and validation
- Water validations
- Contract manufacturing
We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize bovine
virus testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.