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Advancing the State of the Art & Transforming Innovation into Practice

The COVID-19 pandemic has taught us that the targeted use of rapid microbiology methods is not only possible, but scalable and, when used in combination, can be effective for early detection (lateral flow tests) and confirmation of infection (PCR). Without the driver of a global pandemic for technical innovation, how do we transform current rapid methods innovation into practice to further improve product safety for patients and consumers?

Existing culture methods are openly acknowledged for their limitations in sensitivity (1) and time-to-result, requiring additional testing to confirm and identify detected biologics. As rapid microbiological methods (RMM) offer improvements in speed-to-result, sensitivity of detection down to a single-cell level, confirming the presence of microbes, and also the potential of metabolic, chemical and genomic information, how can we use, qualify and target these methods appropriately?

Wouldn’t it be nice if there was a face-to-face workshop where you could connect with industry and regulatory experts who deal with these interconnected challenges in developing, qualifying and applying new technologies on a daily basis? We have just what you want: the 2022 PDA Rapid Microbiological Methods Workshop will be held in Washington, DC, on October 12-13.

Day One starts our journey into the current state of the art, exploring the heritage and importance of company culture for adopting rapid methods, current external regulatory expectations for their acceptance, and an interactive training session on the best use of statistics to support existing and new rapid-method approaches.

The Day Two program focuses on the science of applied and emerging technology from industry-based users and suppliers. Cross-industry case studies highlight the practical use of cytometry in water and environmental monitoring, followed by “in flight” industry-based programs where confocal Raman, solid phase cytometry and dielectrophoresis are being evaluated for single-cell sensitivity. Reprising the theme of the importance of an innovation culture, feel free to provide your experience of internal challenges your company may have seen in adopting rapid methods via a staged role-play session.

In the afternoon session, supplier-based sound bites on the science behind new and emerging RMM and automation technologies will be provided. A focus on the practical implementation of MycoSeq and the evolution of emerging rapid sequencing measurement technologies in the process environment will set the scene for a presentation from a NIST-sponsored cross-industry consortium on how we transform standards to match these emergent RMM technologies. Closing the conference, the RMM Workshop Chair will make his concluding remarks on how the workshop has met the objectives of advancing the RMM state of the art and transforming these innovations into routine practice.

We hope to see you there!

References

  1. U.S. Pharmacopeial Convention. General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 39–NF 34, USP: Rockville, Md., 2016.

About the Author

Kevin WrightKevin Wright, PhD, is Technical Director of Industrial Microbiology for Procter & Gamble Technical Centres Ltd. With 25 years of experience in microbiology and life sciences challenges in the fast-moving consumer goods industry, spanning R&D and industrial microbiology, Wright has worked across various regulated sectors for nonsterile products (health, home and beauty care). This journey has involved novel technologies, new products, and new and reapplied methods, covering both upstream and downstream applications, and with solutions and innovation enabled through a combination of internal research, external collaborations (academic and SME) and participation in cross-industry groups (Kilmer/Microbiology Modernisation Cross Industry Consortium). As an industrial microbiologist, this has led to a considerable range of interconnected topics including biofilms, traditional, analytical and molecular methods, modeling and the integration of different manufacturing operations to deliver a quality end point. Most recently, his focus has been on the application of these alternate approaches and measurements to microbiology in the assessment of the end-to-end quality of manufactured P&G products to facilitate rapid release, including confocal Raman spectroscopy as a quality tool.

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