Pharming reports that its facilities for the manufacturing of Rhucin® have successfully passed the EMEA’s inspections. The drug is being developed to treat acute attacks of hereditary angioedema.
The EMEA has confirmed that all sites and processes that are involved in the manufacturing of Rhucin®, Pharming’s lead product, operate according to GMP standards. This includes the company’s buildings for transgenic rabbits, external facilities where milk and product are stored and processed, and the headquarters in Leiden as far as it is concerned with quality aspects of Rhucin.
“Obtaining the GMP status for our facilities and processes is testimony to the hard and excellent work that our team has put in to convert a research idea of ‘turning milk into medicine’ into a well developed and GMP-approved manufacturing process. Our transgenic rabbit facility is the first of its kind in the world to obtain this status,” says Bruno Giannetti, COO at Pharming.
Rhucin (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming’s technology in milk of transgenic rabbits. The disease is caused by a shortage of functional C1 esterase inhibitor in patients and results in an over reaction of the immune system.