Corporate Banner
Satellite Banner
Cell Culture
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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

Join For Free

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 4,000+ scientific posters on ePosters
  • More than 5,300+ 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 TechnologyNetworks.com 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.


Scientific News
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
More Effective Strategy for Producing Flu Vaccines
Researchers have developed a virus backbone, allowing producers to grow vaccine viruses in mammalian cells, rather than in eggs.
Inspiring Futuristic Innovation: Brain ‘Organoids’
Scientists create artificial brains, providing an advanced model for studying brain tumour development.
Tissue Damage Is Key for Cell Reprogramming
Researchers have shown tissue damage is important for cells to return to an embryonic state for cell reprogramming.
Making Personalized Medicine a Reality
Groundbreaking technique developed at McMaster University is helping to pave the way for advances in personalized medicine.
Regenerating Diseased Hearts
Researchers from the University of Otago have probed the potential of adult stem cell types to repair diseased hearts.
Using Cancer Cells' Mass to Predict Treatment Response
A device has been developed that can detect changes in cell mass at a minute scale.
Color-Coded Stem Cells
Researchers develop colour-coding tool for tracking live blood stem cells over time.
Human Intestines and Functioning Nerves Engineered
The new technology enables the study of human health and advances the goal of regenerative medicine.
Chemical Snapshots Could Lead to Better Engineered Cartilage
Taking "chemical photographs" of the cartilage between joints and comparing it to engineered versions could lead to better implants, say researchers.
Skyscraper Banner

SELECTBIO Market Reports
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
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!