Abionyx: Successful completion of third GMP batch of CER-001
The company thus confirms that its new production line is ready for market access for the only recombinant apoA-I protein, enabling it to serve its target markets in kidney disease, sepsis and ophthalmology.
This will enable Abionyx to prepare for biomanufacturing, which will require three consecutive GMP pilot batches at the yield level of CER-001's future commercial operation, in order to obtain marketing authorization.
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