Avista Pharma provides Mycoplasma testing services to meet regulatory requirements in USP <63>, EP2.6.7 and FDA.
Points to Consider:
- Direct Culture Method per USP <63> and EP2.6.7
- Indicator Cell Culture Method per USP <63> and EP2.6.7
- Direct and Indicator Cell Culture Methods per FDA Points to Consider Guidelines
Testing for Mycoplasma is a necessary quality control requirement to assure reliably pure biotechnological products and allied materials used to generate these products. The genus Mycoplasma, a common cell/ tissue culture contaminant, represents a group of minute bacteria which have no cell walls. The presence of Mycoplasma species does not always result in turbid growth in cultures or visible alteration of cells, and a cell culture infection may persist for an extended period of time without causing apparent cell damage.