EC says separate GMP for cell and gene therapies is necessary
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
Archives for March 21, 2017
German Merck taps up cell-based pyrogen detection kit
Solvias has struck a deal with Germany’s Merck to supply a monocyte activation test (MAT) kit for detecting pyrogens in pharmaceutical raw ingredients.
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AstraZeneca gets second CRL for Zs-9 after inspection at Zs Pharma Texas plant
The US FDA has issued AstraZeneca with a second CRL for its hyperkalaemia candidate Zs-9 after finding problems at a Texas facility operated by subsidiary Zs Pharma.