Fastest Spent Media Analysis Validated against ICH Guidelines: Spinnovation Biologics' Spedia-NMRTM Meets Stringent Pharma Guidelines

19 November 2012: Spinnovation, Nijmegen, The Netherlands: The increasingly popular cell culture analysis and optimization method, Spedia-NMR™ from Spinnovation Biologics, has now been validated internally in accordance to industry guidelines for analytical procedures issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). More specifically, the internal validation has been design-based on ICH-Q2A and ICH-Q2B guidelines for validation of analytical procedures. Providing rapid, quantitative, multiplex analysis of cell culture media, Spedia-NMR™ demonstrates validated levels of specificity, linearity, range, precision, accuracy, limit of detection and quantification for over 50 compounds.

“Over the past 2 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. ” said Dr Frederic Girard, CEO of Spinnovation Biologics.

Advanced and robust cell culture media analysis supports rapid fine-tuning of cell culture feed strategy for improved cell growth and production yield. Recognised to be both more rapid and reproducible than liquid chromatography (LC)-based techniques for cell culture media analysis, Spedia-NMR™ technology is finding an expanding customer base among suppliers, CMOs and biopharma companies. It provides the fastest and most detailed analysis including volatile metabolites and can even identify unanticipated compounds (e.g. contaminants), saving both the time and cost of multiple analyses and troubleshooting campaigns.

Spinnovation Biologics offers Spedia-NMR™ alongside a wide range of complementary analysis methods for troubleshooting in bioprocess and performing simple to complex profiling and characterization of raw material, biologics and biosimilars (including peptides, proteins, oligo/polysaccharides). All services are available on a contract or pay-per-sample basis to suit individual client requirements.

Further information including case studies demonstrating the Spedia-NMR™ technology, can be found at:

www.spinnovation-biologics.com

Spedia-NMR™ is a registered trademark of Spinnovation Analytical BV

High resolution image attached or available from Elen Chesterman,

Kapler Communications ellen.chesterman@kapleronline.com Ref: SPI/JOB/018

About Spinnovation Analytical BV

Spinnovation Biologics is a division of Spinnovation Analytical BV (Nijmegen, The Netherlands, www.spinnovation-analytical.com).

Spinnovation is a contract research organization expert in delivering analytical service to the Industry (Pharmaceuticals, Chemicals/Polymers, Food Products). Its expertise and core activity focuses on the use of Nuclear Magnetic Resonance Spectroscopy (NMR) and Mass Spectrometry (MS) to study molecules and materials.

For press information, please contact:

Alexandra Jones, Kapler Communications

Phoenix House, Phoenix Park, Eaton Socon, Cambs, PE19 8EP, UK

Tel: +44 (0)1480 471059; Fax: +44 (0)1480 471069 alex.jones@kapleronline.com

Spinnovation contact:

Dr. Frederic Girard, Spinnovation Analytical BV, Toernooiveld 1, Mercator III, 6525 ED Nijmegen, the Netherlands. Tel.: +31(0)24-240-3400, e-mail: info@spinnovation-analytical.com/ info@spinnovation-biologics.com