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
Emerging Model of Cancer
Cancer acts cooperatively, making individual decisions but acting in unison; this insight is being used to create a computer model of cancer.
Characterizing the Mouse Gut Microbiome
Study establishes the first public collection of bacteria from the intestine of mice.
How Cloud Connectivity Can Combat the Reproducibility Crisis
This infographic explains the reproducibility crisis, and how cloud connectivity can help overcome this problem.
Stem Cells Grown On Scaffold Mimic Hip Joint Cartilage
Adult fat-derived stem cells grown on a 3-D scaffold that mimicked a hip joint surface formed cartilage and maintained the correct shape.
'Fixing' Blood Vessel Cells To Diagnose Blood Clotting Disorders
A novel microfluidic device detects how endothelial cells that line vessels contribute to hemostasis.
Using Animal Embryos Containing Human Cells
With recent advances in stem cell and gene editing technologies, an increasing number of researchers are interested in growing human tissues and organs in animals by introducing pluripotent human cells into early animal embryos.
Engineering Cells to Speed Tissue Repair
Kelly Schultz studies how cells remodel their microenvironment - a crucial step toward engineering cells to move through synthetic material for faster tissue regeneration.
Cancer Cells Migrate Towards Oxygen
Bioengineers report results showing sarcoma cells in mice finding pathways toward higher concentrations of oxygen
Biopharmaceuticals on Demand
Portable production system would use microbes for manufacturing small amounts of vaccines and therapeutics.
Singapore Scientists Grow Mini Human Brains
Mini midbrains provide next generation platforms to investigate human brain biology, diseases and therapeutics
SELECTBIO

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!