Ensuring the sterility of products is vital for the pharmaceutical and biotech industries. They are guided by tight regulations and have dedicated teams to ensure these are upheld and the risk of contamination is low.
It might therefore surprise you to learn that compendial contamination tests take so long, 14 weeks to be precise, that results may only be received by the manufacturer after the product has been sent to patients.
For short-shelf-life products, this could mean the patient is treated before results of the contamination tests have been yielded, potentially leading to patient harm. Even newer, faster technologies take around 4 days for results, costing manufacturers time and resource.
That’s why Microgenetics have developed SwiftDetect: a rapid microbiological method able to identify any bacterial or fungal contamination in any liquid sample, yielding results in under 6 hours.
“This will be a game-changer, particularly for short shelf-life products where a fast turnaround time is vital”, explains Andrew Davies, Managing Director at Microgenetics.
“Using SwiftDetect will allow manufacturers to be confident in the sterility of their products before release. This could mean saving time and potentially money by reducing delays and the number of recalls through taking action sooner”.
Microgenetics are already solving some of the biggest challenges in the Pharma and Biotech industries with their innovative SmartControl Technologies.
SmartControl EM is a seamless software solution to help facilities gain confidence in their environmental monitoring. SmartControl Colony Counter uses a cutting-edge Machine Learning model to automate the usually error-prone process, even on complex samples.
For SwiftDetect, trials are underway in the Pharma and Biotech industries. So far, the test demonstrates single CFU detection in a variety of samples, including biologics and tissue sample media.
“We’ve yet to find a sample type or volume that’s incompatible”, comments Dr Rebecca Sanders, Principal Scientist at Microgenetics.
“SwiftDetect is therefore suitable for various applications, from sterility to raw material testing”.
Microgenetics is now on the lookout for development partners, who will work with them to validate real-life samples and bring SwiftDetect to market. Watch this space!