Impact of Regulatory Evolution on the Implementation of Alternative Methods

Automated methods are used for rapid microbial contamination detection in short-life products such as cell and gene therapies (C&GT). Although most relevant microorganisms are detected in less than 72 hours, the most common practice is the product release after 7 days of incubation, mostly guided by the European Pharmacopeia Chapter EP 2.6.27.

The introduction of the United State Pharmacopeia chapter USP <72> and the upcoming revision of EP 5.1.6 provide greater support to the manufacturers to release their products in fewer than 7 days, providing guidance on the method implementation and the incubation time determination. Specifically, the revised EP 5.1.6 chapter (implementation 1st April 2027) further clarifies the responsibilities of suppliers and users, in particular for the primary validation and the comparability. It also provides additional information to optimize the implementation strategy.

This poster presents data demonstrating how the optimization of a Rapid Microbiology Method (RMM) can reduce the Time To Results (TTR). Considering the above-mentioned regulatory guidance, we show that users can capitalize on suppliers’ data to optimize their implementation strategies and significantly reduce their effort.