According to Johnson & Johnson, the Geel, Belgium facility produces 54 different types of APIs and three semi-finished APIs, via more than 350 different synthesis steps. In total, the Geel produces +/- 60 % of the total small-molecule API volume within the company. Johnson & Johnson recently updated its Manufacturing Execution System (MES) to PAS-X V3.1.5. The Geel site plays a key role for J&J: there, PAS-X is in operation as full-blown MES in several areas of its API manufacturing lines and warehouse operations. About 300 employees use the system, says Werum, to achieve operational excellence and transparency at the 450.821 m2 site.
“Johnson & Johnson has already implemented Werum’s PAS-X in some plants,” says J&J’s Anje Vermeiren, senior manager, Manufacturing Systems. “After operating the previous version for about two years, we have updated the PAS-X system in Geel in order to benefit from the improved out-of-the-box product functionality, such as enhanced Master Batch Record functions, easier ways of reviewing Electronic Batch Records–and enriched handheld functionality.”
In addition to the production of APIs, the J&J site fulfills a strategic role as a launch and growth site for new products, says the company. Within this role, the Chemical Development Pilot Plant or CDPP—now operational after six years of development— hosts new production processes development in order to enable clinical (phase III) tests. Additionally says J&J, “Small volumes of commercial products are also produced there. Once the medicine is launched, we, as a growth site, try to optimize the production process with the ultimate aim of producing medicines efficiently and in an environmentally-friendly manner and to make them affordable and available to the patients worldwide.”
According to J&J’s web site, the company employs innovative production techniques including spray drying, inspired by techniques used in the food industry. “This technology was first applied for one of our HIV/AIDS medicines, and recently also for INCIVO™. The HIV/AIDS medicine INTELENCE™ (etravirine). ”Johnson & Johnson says the drug would never have been launched without this technology.
In 2011, Geel was closely involved in the launch of six new products: INCIVO™ (against hepatitis C), ZYTIGA™ (prostate cancer), EDURANT™ (HIV/AIDS), XEPLION™ (schizophrenia), NUCYNTA ™ (pain relief) and SIRTURO™ (tuberculosis). Geel is currently also preparing for TMC435 (to combat hepatitis C) and INVOKANA™ (canagliflozin, against type 2 diabetes), launched in the U.S. April, 2013.
GREEN PRODUCTION PROCESSES
The facility in Geel is the first LEED-certified building in Belgium and the first chemical manufacturing facility in Europe to achieve LEED certification. On its web site J&J declares its production processes are “state-of-the-art” explaining that for its operations the environmental aspects associated with production are integrated into the overall development process. “Whenever the synthesis of a particular product is defined, its score in terms of environmental friendliness is always examined,” says J&J. “On the other hand, technologies that could be used to make the process as efficient and as green as possible are also reviewed. For example, ZYTIGA™, produced at Geel, obtained the Earthwards™ label in 2012.” This recognition explains J&J, confirms that significant improvements were implemented with respect to the sustainable production of the product. “In the case of ZYTIGA™, this meant that the amount of raw materials that were used, the water consumption during synthesis and the production of hazardous waste, amongst other things, were significantly reduced,” says the company no doubt leveraging its IT infrastructure to achieve these goals and also understand a wet crystallization and extraction process which was applied during the production of an active substance for the first time within J&J.