PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing, is now published. The scope of the TR is the application of non-culture testing methodology, including nucleic acid amplification and other assays, for the detection of mycoplasmas in cell cultures and biotech products. The TR describes assay procedures, assay validation, demonstration of comparability to reference methods, and potential applications for alternative methods. PDA members may be downloaded the TR for free until October 14, 2010.
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA