Final products from biopharma manufacturers are regulated by the FDA and rigorous testing protocols are implemented to minimize the chances of a contaminated product causing illness to consumers. Any detectable viable contaminant generally prevents the sale of a product, resulting in significant monetary loss.
The time required to complete product testing by culture introduces a delay that can take up to 28 days to confirm a result. This delay lessens the profitability of a product because cold storage is expensive and storage time reduces the shelf-life of the product. To avoid this time delay, manufacturers are increasingly turning to faster alternative rapid microbiology methods (RMM) for testing.
The most popular RMM relies on PCR to detect contaminants. One of the benefits of PCR is that it provides results in just a few hours (rather than days or weeks for culture) and is extremely sensitive for the detection of contaminants. It can also be used to detect any biological contaminant of interest, whether it is a virus, fungus, or bacterium. This is not true for culture-based methods, as some organisms are either extremely difficult or impossible to culture, which creates a blind spot for safety officers.
To maximize the speed advantage of PCR, this technology can be used inside the biopharma manufacturer’s site rather than relying on reference laboratories to do the work.
An added challenge for performing PCR inside a biopharma manufacturing facility is that it is often necessary to process up to 10 mL of a sample (or product) to confirm it is free and clear of contamination. To successfully screen these 10 mL for contaminants by PCR, the sample must first be reduced down to a much smaller volume (e.g., 100 uL, or a 100x concentration step). This concentration step is traditionally achieved by using a centrifuge. However, it is nearly impossible to use a centrifuge in a biopharma manufacturing facility since it requires a considerable amount of technical expertise and is prone to failure when very low concentrations of viruses, fungi, or bacteria are present.
Alternatively, samples can be concentrated inside a disposable cartridge where the sample passes through a filter that captures contaminants on the surface (see illustration below) and this cartridge is fluidically connected to a fully automated microfluidic system that performs PCR. An advantage of an automated device that can handle the flow-through from cartridges is that it can process large volumes of sample for the sensitive detection of common contaminants.
LexaGene’s MiQLab™ System is the only fully automated system on the market today that is equipped with a disposable filter-based sample preparation cartridge that allows for efficient processing of large volumes of sample for sensitive detection of contaminants. The ease-of-use, fast time-to-results, and extreme sensitivity of the MiQLab System makes it an ideal solution for PCR-based contamination testing inside biopharma manufacturing facilities.