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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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
Genetic Variability in Cell Bank Lots
Researchers working with cancer cells from the same cell bank acquired at the same time, found that the cells were genetically different.
3D Models May Yield Ovarian Cancer Insights
Researchers are developing new tools to decipher ovarian cancer developments through a 3D printing technology.
A Novel Cell Culture Model For Forensic Biology Experiments
Researchers have developed a new cell culture model which provides an efficient research tool in forensic biology.
Mapping Zika’s Routes to Developing Fetus
UC researchers show how Zika virus travels from a pregnant woman to her fetus, and also identified a drug that could stop it.
3D Printing Cartilage
3D bioprinting has successfully manufactured cartilage using bioink sourced from cow cartilage strands.
New Device can Study Electric Field Cancer Therapy
Microfluidic device allows study of electric field cancer therapy through low-intensity fields, preventing malignant cells spreading.
Scientists Culture Elusive Yellowstone Microbe
ORNL scientists have successfully isolated and cultured a Yellowstone sourced acidic hot-spring based microbe.
A 3D Paper-Based Microbial Fuel Cell
Researchers have developed a proof-of-concept 3D paper-based microbial fuel cell (MFC) that could take advantage of capillary action to guide the liquids through the MFC system and to eliminate the need for external power.
Just Gellin’: How To Grow Strong Muscles-On-A-Chip
USC researchers hope to usher in new treatments for patients with muscular dystrophy.
Lasers Carve the Path to Tissue Engineering
A new technique, developed at EPFL, combines microfluidics and lasers to guide cells in 3D space, overcoming major limitations to tissue engineering.
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!