USP <77> and Rapid Mycoplasma Testing: Enabling Faster Biosafety Decisions for Advanced Therapies

As cell and gene therapies, biologics, and other advanced therapeutics continue to accelerate timelines from campaign start to patient treatment, rapid biosafety testing must evolve to keep pace. Nucleic Acid Technology (NAT) assays have been used to support campaigns for the detection of mollicutes, while leveraging the framework provided in USP <63> and USP <1223>.  

USP <77>, Mycoplasma Nucleic Acid Amplification Tests, brings clarity to regulatory expectations, validation requirements, and method qualification for NAT assays. This chapter was developed with lot release of the final product in mind, indicating that USP <63> and USP <1223> guidance still retains a place in biosafety testing when utilising NAT assays.  

In this webinar, we will discuss:

• The purpose and scope of USP <77> and how it creates a framework for NAT-based mycoplasma testing.
• The validation requirements for NAT assays, including specificity, sensitivity, robustness, and suitability.
• The sample types addressed within USP <77> and the unique considerations for testing complex matrices and advanced therapy products.
• USP <77> in complementing USP <63> and USP <1223>
• Strategies to reduce testing timelines while maintaining compliance and ensuring patient safety.

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