P5, Genzyme, (http://www.genzyme.be/default.asp) Genzyme will play a key role in WP2 implementation. Genzyme is a particularly interested party in this education project, as education resources are hard to find. To date, Genzyme has invested substantial time and resources to educate and train their personnel. This project will enable Genzyme to have readily educated industrial pharmacists available to support their current operations and the expansion project.

In October 2001, Genzyme Corporation acquired the Belgian part of Pharming N.V. in Geel, Belgium to develop Genzyme’s first bio-therapeutics manufacturing facility in Europe. The manufacturing facility comprises a continuous production line for the manufacturing of enzymes for enzyme replacement therapies and a fed-batch production line for the manufacturing of therapeutic monoclonal antibodies. The first product is the enzyme replacement therapy for Pompe disease, a rare genetic, often fatal, disease of the muscle. Regulatory approval for commercial production of this enzyme was received in 2009-2010 for the EU, Japan, Canada, US and Brazil. The monoclonal antibody produced in Geel was for the treatment of B-CLL leukaemia. The approval of its manufacturing for the EU and the US was received in 2009 and 2010. The same monoclonal antibody is also being evaluated in a number of clinical trials for treatment of other cancers and multiple sclerosis.

The managerial tasks at Genzyme will be assumed by Gunther Pauwels who currently holds the position of Senior Director Quality Affairs at Genzyme, Geel, Belgium. Gunther Pauwels has a worldwide experience and expertise (>15 years) in the design, start-up, qualification and validation of multiple Pharma en Biotech production units. His specialized education as an Industrial Pharmacist has enabled him to absorb solid and pragmatic expertise in the various elements within the Pharmaceutical Quality arena. Gunther Pauwels believes in systems, organisation and governance; ‘Quality is not a silly coincidence, but a result of careful planning and meticulous execution’. Gunther Pauwels is an active member and speaker within recognised industry-associations such as VAPI, ISPE, PDA and ASQ; and is a certified (ASQ) Quality Auditor.