
For new biologicals and biosimilars, the innovative Spedia-NMR
TM technology from Spinnovation Biologics provides a real advantage for optimizing cell cultures, monitoring and standardizing manufacturing processes in preparation for larger scale production.
Within the past four months, this has been validated by 37 companies
developing biologics or delivering services to this industry.
This
premium nuclear magnetic resonance (NMR) analysis service rapidly
identifies a wide selection of feed components, metabolites and toxic
compounds in culture media. By comparing media
profiles from different cell culture batches, Spedia-NMR
TM identifies
how a cell consumes and metabolizes the media along the culture process.
This allows the composition of the media to be fine-tuned to improve
cell viability, reach highest yields of biologic product and perform
rapid process troubleshooting.
Spedia-NMR
TM
technology has gained rapid popularity in both the biotech research and
manufacturing communities because of the speed of analysis (analyse in a
matter of minutes/hours, delivery of service within five working days)
and the valuable information it provides in assisting process
development.
Dr Frederic Girard the CEO of Spinnovation said recently about his perception of the value of Spedia-NMR
TM to biotech companies, "
In
the short term, Spedia-NMRTM will fill the gap in knowledge to
strengthen and speed up cell culture development and upstream
processing... clients need to know what is going on in their cell culture
and they need to know it fast," Dr Girard then went on to discuss the mid-term value of services from Spinnovation Biologics, "
In
the mid-term we will be able to provide methods and tools to our
clients to help them to cope with the demand of FDA edicts regarding
Quality by Design (QbD) and validation in the production environment."
Spedia-NMR
TM
technology is available on a fee-for-sample or as a contract service to
all biotech. Users range from medium to large biotech companies and
some academic clients use this specialist service in their protein
therapeutics research. The true adaptability of Spedia-NMR
TM analysis has
led to its application across a range of cell systems and production
platforms including: CHO, stem cells and virus production platforms.
Spedia-NMR
TM is designed to perform rapid, high throughput analyses of
cell culture media batches and feed-batches in a very cost-efficient
manner, using fully automated sample analysis and data processing.
For further information, please visit:
www.spinnovation-biologics.comSpedia-NMR is a registered trademark of Spinnovation Analytical BV