The purpose of sterility testing is to detect microbiological contaminants such as bacteria, yeast and fungi. The US and EU Pharmacopoeia, and USFDA PTC guidelines describe several techniques for the detection of bacteria in cells or cell-derived products.
In accordance with the ICH Q5D, Texcell has developed specific assays to detect bacterial and fungal contaminants for unprocessed bulks, cell banks and cells.
Available sterility assays include but are not limited to:
- Detection of bacterial and fungal contaminants utilizing a direct inoculation method
- Detection of bacteriostatic and fungistatic activity utilizing a direct inoculation method
- Detection of bacterial and fungal contaminants using a filtration method
- Mycobacteria and tuberculosis detection