PDA New England Chapter Webinar: Sterility Testing of ATMPs

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The need to utilize rapid sterility testing is gaining momentum within our industry, especially for short-life drugs with an immediate patient need, such as advanced therapy medicinal products (ATMPs; cell & gene therapies). This webinar will explore the challenges of mfg. & releasing ATMPs & the benefits of implementing rapid sterility test strategies. We will also discuss the global regulatory policy changes that support using rapid sterility tests for these types of products, as well as the introduction of compendial chapters providing guidance for validation & implementation. We will finish with case studies on how rapid sterility validation studies may be performed.

In this presentation, the following will be discussed:

  • Assess the current state of sterility testing for ATMPs and the need for rapid testing solutions
  • Review current regulatory policies and compendial guidance for rapid sterility testing
  • Understand the required validation parameters including limit of detection, specificity, method suitability and equivalence
  • Consider sampling strategies when compendial requirements cannot be met
  • Discuss the impact of short-life products on detection time
  • Provide examples of rapid sterility validation strategies
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