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.
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
- Adventitious agents
- Retrovirus infectivity assay
- Replication competent adenovirus (RCA) assay
- Vaccine Testing
- Bulk harvest/In-process samples
- Cross-reactivity testing
- Custom assays
- Animal-Derived Materials
- Endotoxin testing
- Virucidal and antimicrobial efficacy studies
- Environmental monitoring
- Package stability and validation
- Water validations
- Contract manufacturing
We understand that no two production plants are 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.