BioReliance Launches Validated Assay

BioReliance has launched a fully validated assay which can sensitively detect the presence of Calicivirus 2117 in biological samples. The test is designed to provide manufacturers of biological therapeutics and other biologically based products the ability to detect this potential contaminant of mammalian cell culture based systems.

Reportedly, Calicivirus 2117 (also referred to as Vesivirus 2117) was recently described as the causative agent in the shutdown of a major biotechnology manufacturing facility.

The company said that it is offering this assay through its MHRA and FDA inspected GMP compliant testing facilities.

David Onions, chief scientific officer of BioReliance, said: “We are pleased to offer this important assay to the pharmaceutical and biotech industry as part of our commitment to develop innovative services for our clients. Application of this assay will become a key safety feature for CHO based production systems.

“We developed and validated this test to ensure that our clients receive the highest level of assurance that their manufacturing processes are free of contamination while ensuring regulatory compliance.”