in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of TGA approval for Capsugel’s plant, Spain’s first therapeutic protein plant and Isogen setting up in Delaware.
TGA approval for Capsugel plant
Capsugel has received certification for its Licaps liquid-fill capsule production facility in Greenwood, South Carolina from the Therapeutic Goods Administration (TGA), a division of the Australian Department of Health and Ageing.
Manufacturing facility certification is one of the steps required before a therapeutic product can be included in the Australian Register of Therapeutic Goods (ARTG) and sold in the country.
Robert Whitelaw, director of sales, marketing and business development for Capsugel’s Americas region, said: “In conjunction with the growing demand for products that utilise the Licaps liquid delivery system, our customers can now more readily access important global markets.
“Certainly, our experience is that the important benefits of the Licaps delivery system, which include heightened consumer preference and improved bioavailability, address global needs.”
Spain’s first therapeutic protein plant due in 2009
Spanish biotech company 3P Biopharmaceuticals is on course to complete its therapeutic protein manufacturing plant in Noain, Spain at the start of 2009.
The plant will be the first in Spain to produce therapeutic proteins for laboratories and pharmaceutical companies. An investment of €15m has been made to construct the plant.
Isogen chooses Delaware for facility
US-based Isogen has signaled its intent to build a $115m manufacturing facility in Delaware, which could generate up to 150 jobs.
Construction of the 200,000 sq ft facility is due to commence next year, following completion of the $2.5m design and site preparation process. Completion is penciled in for 2010.
The facility is intended to serve what Isogen believes is a niche in pharmaceutical outsourcing, the small to medium-scale manufacturing of injectable drugs for clinical trials and early commercial sales.
Isogen’s decision to set up in Delaware is being viewed as a coup by the state. Judy McKinney-Cherry, director of the states economic development office, said: "Delaware has been pushing for biotechnology and manufacturing, and Isogen provides this wonderful science and manufacturing combination, so it really does fit our sweet spot."
Isogen is currently leasing space in DuPont's Stine-Haskell Research Center and is planning to relocate its headquarters to the site in January.