Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
The disease is caused by a mutation in the gene encoding HMG CoA reductase, inhibiting the enzyme’s activity.
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
Fermentation-based manufacturing leverages Evonik’s biotechnology platform
The human serum-based system shows reduced interferences when testing for pyrogenicity in more complex drug products, such as in blood-derived therapeutics
Cysoni is a bionic device that paces the heart with real-time respiratory modulation
Researchers from the Tel Aviv University successfully engineer the world's first 3D human spinal cord tissue transplant
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
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