PDA Technical Report No. 50 (TR 50) Alternative Methods for Mycoplasma Testing (single user digital version)

Sep 2010
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Using alternative methodology for the detection of mycoplasma requires validation and demonstration of comparability to reference standards. A PDA Task Force of experts has developed PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods. The report focuses on non-culture testing methodology, including Nucleic Acid Amplification Technique (NAT) assays and enzyme activity based assays. Representatives of the U.S. FDA and the U.S. Pharmacopeia contributed to the report.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Summary of Existing Assays and Compendial Methods
  4. Nucleic Acid Amplification Technique (NAT) Methods
  5. Non-NAT Alternative Methods
  6. Appendices
  7. References
  8. Figures and Tables Index