ALTERNATIVE AND RAPID MICROBIOLOGICAL METHODS: MICROBIOLOGY OF THE 21ST CENTURY

Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr. David Jones, Director of New Products & Industry Affairs at Rapid Micro Biosystems.

Today Pharmaceutical industry remains conservative for microbiology testing methods and has the reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:

– RMM are not accepted by regulation authorities,
– RMM will never replace classical microbial methods,
– RMM will not offer a return on investment (ROI),
– Data generated from RMMs will exceed current specifications and limits involving an increase in batch rejections.

Nevertheless, a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence in the regulatory point of view, have a number of disadvantages such as:

– Time to results in days to weeks,
– Results vary with microbial population, media, culture conditions,
– Lack of reactivity in case of exceeding limit results,
– Sensitivity could be insufficient given underestimations in the contamination risk,
– The existence of confluent growth.

This webinar provides an overview of the current situation about RMM technologies, and regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.