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Rapid microbiological methods (RMMs) encompass any technology that allows a user to get microbiology results faster compared to traditional methods. RMMs were first commercialized in the 1990’s, but the pharmaceutical and biopharmaceutical industries have been slow to embrace these faster technologies. Why? Historically, the challenges in implementing RMMs have been in regulatory acceptance and the perceived cost of implementation.

As we are well into the 21st century, tides have started to shift. Regulatory pathways for validating RMMs are well-defined and there are many options on the market. Additionally, novel cell and gene therapies have helped push a more widespread acceptance of rapid and alternative methods due to their short shelf life and low production volume, which can be difficult for traditional methods to accommodate.

One main barrier to adopting RMMs remains: typically, RMM technology comes with an upfront capital investment. However, RMMs have some key advantages that could ultimately result in significant long-term savings. 

1. Considerable time-savings

For an alternative method such as an RMM to be used as a replacement for a traditional method, the new technology must be validated and perform as well as, or superior to, the original method. In the case of RMMs, this superiority usually translates as faster time-to-result and increased efficiency.

Traditionally, growth-based methods require growing microorganisms in media, which microbiologists must examine visually, looking for colony-forming units (CFU) in solid media types and measuring turbidity in liquid broths. Both of these processes can take days due to the limitations of the human eye—microorganisms must develop and become large enough for a microbiologist to be able to examine. RMMs, on the other hand, usually use markers that can be detected by an instrument at a low number of CFU. By eliminating the lengthy colony-forming step, RMMs are able to produce results much faster, even within hours.

2. Immediate reactions to contamination

Corrective actions can be taken earlier because RMMs provide faster results, thus enabling a more proactive response to instances of microbial contamination and out-of-trend situations. With traditional methods, results can take days, making it difficult to pinpoint exactly when and where a contamination issue may have originated. Additionally, RMMs can assist in the design of more robust, automated processes that could reduce the opportunity for contamination altogether.

3. Financial savings and brand protection

The speed and efficiency that RMMs can bring to an operation can have a significant effect on an organization’s bottom line. From a manufacturing perspective, a faster time to result can enable companies to release raw materials quickly, transfer in-process work to the next stage, and bring finished products to market, which can shorten the production cycle, reduce inventory requirements, and free up working capital.

As mentioned above, RMMs offer the ability to quickly detect, control, and recuperate from contamination issues—and any delay in identifying a contamination event can have a major financial impact. Thus, the added speed and agility that RMMs offer may facilitate substantial financial savings and brand protection.

4. Optimization of staff time and labor

Traditional microbiological methods are not only time-intensive, but labor-intensive. Automating key processes with RMMs can free up staff to focus on more impactful activities that can bring more value to the organization.

Along the same lines, with automation usually comes enhanced objectivity. Some rapid methods can help laboratories reduce worker subjectivity, and automated systems that provide test results in a clear, pass–fail approach can take the guesswork out of plating and waiting.

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Despite RMM technology typically coming with a higher up-front cost, the advantages over traditional methods must be calculated into the organization’s ROI. Many of the benefits of RMMs contribute to increased savings, which can outweigh the initial cost over time. In the ever-evolving pharmaceutical landscape, adoption of RMMs can help optimize laboratory workflows, leading to overall financial gains and impact outside of the laboratory.  

Opinions expressed in this article are not necessarily those of bioMérieux.


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