GeneDisc offers time savings for biopharma manufacturing

Uses novel qPCR technology

The GeneDisc Rapid Microbiology System from Pall Corporation, a US-based filtration, separation and purification specialist, is a family of assays designed to accelerate routine microbiological testing, offering an easy-to-use product that requires minimal training.

System components include the GeneDisc DNA Extractor for sample preparation; the GeneDisc plate in which assays are run; and the GeneDisc Cycler, which carries out the assay and records the results.

“This reliable, simple to use, and robust platform represents significant time savings over traditional incubation sampling methods and can allow materials and final products to be released more quickly, improving production efficiency and reducing inventories,” said Ken Frank, president of Pall Life Sciences Biopharmaceuticals division.

The GeneDisc System generates results for most microbiological applications in just a few hours, compared with typical culture-based methods that can take up to five days.

The novel technology of the GeneDisc Rapid Microbiology System, based on bar-coded data input and fewer operator-dependent steps, ensures reliable results that significantly reduce the risk of user error, the company says.

This new application is based on established quantitative polymerase chain reaction (qPCR) technology, which provides a simple, rapid tool for microbiological analysis.

The first of the assays is a Specified Microorganism Test, which simultaneously detects indicator pathogens as required by Pharmacopeia.

Additional assays are planned that will further expand the GeneDisc System to perform accelerated microbiological testing during various stages of pharmaceutical and biotech production.

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