Lonza is spending $26m to expand capacity at its facility in Walkersville, Maryland, US as regulatory progress made with Osiris’ Prochymal looks set to kick start the era of cell therapies.
The firm will install three class 10,000 cell production suites as well as the requisite clean room and processing space at the plant, all of which will be housed in a 44,000 sq ft, purposed designed building.
A company spokesman said that a key function of the facility will be to provide manufacturing space for its contract work, including for the production of Prochymal under a contract signed with Osiris Therapeutics last year.
The drug, a graft-versus-host-disease candidate for transplant patients, was recently the subject of a “successful pre-Biologics License Application meeting” with the US Food and Drug Administration, according to Osiris and development partner Genzyme.
The Lonza spokesman also said that when fully operational at the end of Q1 2010 the Walkersville site will be capable of working with, keratinocytes, fibroblasts, vascular endothelial cells, renal cells, dendritic cells and myoblasts.
He commented that: “Cell therapy is still at an early stage of its life cycle. Currently, it is only a small portion of the total Lonza revenue. As cell therapeutics move from clinical development to commercial products, Lonza expects the revenue generation to become more significant.”
“Currently, demand for the cell therapy companies and products are primarily in North America and Europe. During this phase of development it is easier for manufacturing to be closer to the client company and to patients. Lonza plans to expand its cell therapy manufacturing base to other areas…as the market demand requires.”
The Walkersville site, which was bought from Cambrex in 2007 for $460m, currently employs 450 people in the fields of cell research, endotoxin detection and cell therapy manufacture. The expansion will create around 80 new manufacturing jobs.