Tough demands in complex job

#1/2009
Text: Karin Rehn

The first batch of pharmaceuticals manufactured at the research unit AstraZeneca R&D in Mölndal, Sweden, will be ready in early 2010, and the new production premises will soon be ready for inspection. The demands are tough, but the complex job is proceeding on schedule.

Before a pharmaceutical is registered it must pass through a fine-toothed comb. When finally it is time to test substances on people, it is done first on a small number of healthy volunteers. These are followed by further trials conducted through strictly controlled procedures. The research unit AstraZeneca R&D in Mölndal outside Gothenberg, Sweden, is in the process of building its own pilot plant to manufacture the pharmaceuticals needed for these clinical tests.

“This will be the first plant in the group to have all divisions – stores for source substances, production, packaging and storage for completed pharmaceuticals,” says Tomas Alminger, overall project manager at AstraZeneca. “It is a complicated plant, requiring a huge number of installations. It has put pressure on the subcontractors to coordinate with each other, and it has worked really well.” Pharmaceutical manufacturing has to follow strict GMP rules (good manufacturing practice), high-quality demands and authorised systems. In Mölndal AstraZeneca goes a step further.

“We are investing in containment,” says Alminger. “This means that products are never openly handled at any manufacturing stage or in the process of transport between the different stages. Substances are encapsulated in various ways so as not to risk affecting staff.”

Competence, capacity, quality and price: These qualities are what gained AGA the job of installing the gas distribution system (compressed air and nitrogen) for the new plant. The nitrogen product VERISEQ LIN that will be used in manufacturing has certified and documented traceability, an important GMP requirement in the pharmaceutical industry.

“AGA gas is of indisputably good quality,” says Alminger. “But the company also understands this type of complicated work and thinks in terms of the big picture.”

The new production premises will be an important element in the efficient production of new pharmaceuticals. The manufacturing is flexible; rapid adjustments can be made and different tablets or capsules can be produced simultaneously. In addition, the experience gained and development of the production phases can be used when it comes time for large-scale factory production.

Research in Mölndal has proud traditions to uphold. Three of AstraZeneca’s biggest pharmaceutical products – Nexium, Losec and Seloken – have been produced here.