BOURNEMOUTH, England, November 3, 2016 /PRNewswire/ --
Solentim, the developer of instrumentation for cell line development, announced today that it has launched a major enhancement for its world leading verification of clonality platform, the Cell Metric®. This enhancement, which enables two channel fluorescence on the Cell Metric and Cell Metric CLD, provides for the rapid detection and verification of rare events. Furthermore, this fluorescence functionality has been developed to support some very specific applications in cell line development.
"From our previously published interviews with Dr Audrey Jia (a former chemistry and manufacturing controls (CMC) reviewer for biological products in CDER of FDA) and existing customer collaborations, we identified the need to enable cell line development groups to be better able to perform and document improved statistical qualification for their single cell seeding methods, such as FACS, Limiting Dilutions or other methods," explained Dr Ian Taylor, Sales & Marketing Director at Solentim. Dr Taylor continued, "This added detection of fluorescently-labelled cells should aid further qualification of expected single cell seeding rates/probabilities and also the incidence of 'ghost' wells by carrying out cell mixing experiments. We envisage these experiments being carried out infrequently, with the bulk of the image verification still being done in standard bright field mode."
This enhanced feature is now available as an option with new Cell Metric systems and has already been purchased and adopted by a number of our customers. This option is only currently available for customers in the US and Europe.
Commercial stable cell line development for biopharmaceutical production and gene therapy is a high value process which is inherently expensive and takes a significant amount of time. Solentim® has established itself over the past 6 years as a significant leader and innovator of new products in the cell line development arena.
Our Cell Metric® product range of bright field imaging stations has a large global installed base of customers, and we are recognised as a leader for documenting proof of clonal origin for Master Cell Banks in filings to the regulators.