Technical Brief: Rapid Microbial Detection Methods

Regulatory View on Adoption and Use

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Regulatory View on Adoption and Use

As the pharmaceutical and biotechnology industries continue to innovate to meet patient needs for therapies, new treatments are being developed at an ever-increasing pace. The industry has seen a tremendous growth in innovations such as cell and gene therapies, offering hope of recovery to countless patients. However, a number of such products require a turnaround time of 2 – 4 days to ensure their effectiveness. Traditional microbial detection methods such as plate counts fall short in these applications because they typically require at least five days of incubation to generate results, have limited sensitivity, and may underestimate the actual microbial burden.

Rapid Microbial Detection Methods

Regulatory View on Adoption and Use

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