CRO Spinnovation Biologics says its cell culture optimization technique complies with analytical methods detailed in ICH Q2A and Q2B guidelines.
The method – Spedia-NMR – uses nuclear magnetic resonance spectroscopy (NMR) to analyse bioproduction medias and identify process-critical analytes that can be used to manage culture consistency.
The Netherlands-based CRO said its in-house team have validated that the technique fits with the ICH guidelines, which cover testing and analytical methods used during bioproduction .
CEO Frederic Girard said: “Over the past two years, our Spedia-NMR analysis method has demonstrated clear advantages for optimizing and trouble-shooting cell-based production systems, such as those used for the production of antibodies, cell therapeutics or vaccines.
“This new step reached with the validation of our proprietary method further establishes that Spedia-NMR can be used with confidence not only by researchers, but also by upstream processing and quality assurance teams developing or investigating their process, either in a pilot or bio-manufacturing stage.”
Previously released data suggest that Spedia-NMR - which is central to the Spedia-Predict analysis service the CRO launched in April - method can monitor more than 50 analytes simultaneously and that the firm can process around 100 samples per day, with typical limits of detection and quantification being in the 1 – 10µM and 50-100µM range, respectively.
The approach is one of a number of new culture analysis methods to have emerged this year as a result of the pharmaceutical industry's need to improve the quality of bioproduction processes.
Earlier this month for example Merck Millipore partnered with microRNA detection firm Sistemic to develop QC kits for stem cell production.
The idea is to develop a monitoring methodology utilizing Sistemic's microRNA marker detection system that can be used to improve the growth of cell culture produced using Merck’s CellReady platform.