Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

Spinnovation Biologics’ Spedia-NMRTM Meets Stringent Pharma Guidelines

Published: Tuesday, November 20, 2012
Last Updated: Tuesday, November 20, 2012
Bookmark and Share
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
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More Than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Sinensis Life Sciences Acquires Spinnovation
Addition of Spinnovation expands and strengthens Company’s chemical R&D group.
Saturday, October 04, 2014
Spinnovation Transfers its Entire Operation to Pivot Park
The new location has enabled Spinnovation to double the size of its facilities, to support the growth of its business.
Monday, January 13, 2014
CEO Frederic Girard Joins Fellow Industry Experts for a QbD Round Table
New article on quality by design is now available online.
Friday, August 16, 2013
Spinnovation Expands in to the US
Spinnovation collaborate with Quantum Tessera in Pennsylvania.
Tuesday, April 17, 2012
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Kitchen Utensils Can Spread Bacteria Between Foods
In a recent study researchers found that produce that contained bacteria would contaminate other produce items through the continued use of knives or graters—the bacteria would latch on to the utensils commonly found in consumers' homes and spread to the next item.
Exploring the Causes of Cancer
Queen's research to understand the regulation of a cell surface protein involved in cancer.
Safer, Faster Way To Remove Pollutants From Water
Using nanoparticles filled with enzymes proves more effective than current methods.
Drug May Prevent Life-Threatening Muscle Loss in Advanced Cancers
New data describes how an experimental drug can stop life-threatening muscle wasting (cachexia) associated with advanced cancers and restore muscle health.
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Novel Tumor Treatment
In the first published results from a $386,000 National Cancer Institute grant awarded earlier this year, a paper by Scott Verbridge and Rafael Davalos has been published.
Speeding Up the Process of Making Vaccines
System uses a freeze-dry concept to develop "just-add-water" solution.
Chemical Design Made Easier
Rice University scientists prepare elusive organocatalysts for drug and fine chemical synthesis.
New Analysis Technique for Chiral Activity in Molecules
Professor Hyunwoo Kim of the Chemistry Department and his research team have developed a technique that can easily analyze the optical activity of charged compounds by using nuclear magnetic resonance (NMR) spectroscopy.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos