Pharming doubling downstream capacity for commercial HAE therapy

Pharming Group will build a facility at its site in Oss, the Netherlands to increase downstream manufacturing capacity for Ruconest, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with hereditary angioedema (HAE).

Dutch pharma firm Pharming is building a new facility to expand downstream processing capacity at its site in Pivot Park, Oss.

Once operational, the facility will carry out the purification, filtration and concentration of the starting material for lead product Ruconest (recombinant C1 esterase inhibitor (rhC1INH)).

“The new facility will create at least 100% extra capacity for the manufacturing of Ruconest,” a spokesperson from the firm told us.

“We are not disclosing the full cost of investment at this stage, but we can confirm that it will be recovered quickly, given the lower cost of manufacturing, as we continue to invest in expanding our in-house processing capabilities.”

The firm, which is also moving into a new, five-story building with a total floor space of approximately 4,000 m² at pivot Park, says it will create upwards of 40 new jobs in Oss. Costruction will begin next year.

Pharming bought back the rights to Ruconest in 2016 from Valeant. The firm told us the product – approved in the US and Europe, along with various other markets – is made using Pharming’s own manufacturing platform, Transgenic Production Technology Platform (TPTP) that allows it to reproduce proteins in large quantities using genetically modified rabbits, and in the future, cattle.

“Pharming produces a recombinant version of a human protein called C1 esterase inhibitor (C1INH) by way of genetic modification,” we were told.

“Transgenic or genetically modified organism (GMO) means that a protein has been added to the existing genetic structure of an organism. By genetically modifying rabbits, we can produce a highly glycosylated protein called C1 esterase inhibitor.

“In patients with the disease Hereditary Angioedema (HAE) this protein is either missing or dysfunctional. Except for the additional protein in their milk, the rabbits are the same as regular rabbits.”