Blood plasma requires special treatment

#2/2009
Text: Karin Rehn

When Octapharma develops a new advanced blood plasma product every phase of the manufacturing process is governed by strict rules and regulations. This places great demands on the production plant.

Octapharma is one of the world’s leading – and Sweden’s only – manufacturer of plasma-based pharmaceuticals. It is also a pharmaceutical company with a strong belief in the future, and it invests heavily in Sweden. An important part of the company’s future lies on Kungsholmen, in the centre of Stockholm.

Octapharma manufactures derivatives from blood plasma taken from healthy individuals. These are vital pharmaceutical products that, among other things, are designed to help haemophiliacs and people with serious immunodeficiencies.

The company is expanding, and Alexander Balogh, plant manager at the Stockholm facility, has a more-than-full appointments diary.

“Among other things, we are going to start a new production line to manufacture an advanced blood plasma product,” he says.

The production plant is technically very advanced. The manufacture of plasma-based products is exceedingly complex and includes a gradual fractional precipitation of proteins – plasma fractioning. The product that will soon be manufactured in Stockholm is called Octaplas lg and is a virally inactivated plasma product used during transfusions.

Octapharma in Stockholm already treats more than 600,000 litres of blood plasma every year. The company’s aim is to double production within a few years. At present, there are about 500 employees, a figure that will rise as the new product comes on line.

A completely new cryogenic plant has therefore been installed on the third floor of Octopharma’s Stockholm building on Kungsholmen, ready to freeze the finished product in the final production step. AGA has built, documented, tested and qualified the system.

“We have subsequently used the tests from AGA to carry out our own internal installation, function and product qualification programme,” explains Balogh.

“An important part here is to ensure the quality of the liquid nitrogen used for the freezing phase – the purity, documentation and traceability.”

In general, in the pharmaceutical industry, quality is very strictly regulated, and the production of human plasma-based products is subject to even tougher demands.

“The plant must meet the demands made by the fda (the us Food and Drug Administration), if we are to be granted a permit to manufacture pharmaceutical products for the us market.”