Using GeneDisc a biopharm can generate microbiological analysis data in a few hours. In comparison, culture-based methods can take days to produce results.
“That can mean scrapped or reworked product, which represents considerable risk and cost. With the GeneDisc System, we can reliably eliminate those production risks in just a few hours”, said Peter Ball, technical marketing director for Pall.
Eliminating delays shortens the manufacturing cycle, reducing warehousing costs, quickening time to market and increasing return on investment throughout the production process.
GeneDisc is based on bar-coded data input and established quantitative polymerase chain reaction (qPCR) technology. Using a single-protocol system quickly and easily gives reproducible results, shortening the timeframe needed to perform quality control testing.
Furthermore, the assay is designed for ease of use. This allows operators with relatively limited training to perform the assay, freeing up skilled staff to perform more demanding tasks. Pall also claims quality assurance improvements associated with GeneDisc increased production security.
Introducing GeneDisc based on qPCR is the first step in efforts to provide a complete platform based on the technology for rapid microbiology analysis. Additional assays will expand the GeneDisc range to cover microbiological testing during various stages of biopharm production.
GeneDisc is designed to test for indicator organisms Escherichia coli, Salmonella spp, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus brasiliensis