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US biotech firm ramps up bioprocessing capacity

By Emilie Reymond, 14-Mar-2007

Related topics: Processing & QC

Biotech company Grifols has announced the expansion of its US manufacturing capacity which will allow it to increase the production of its haemophilia therapies.

The company said that a new facility, located at its Los Angeles manufacturing site, will enable it to increase its overall plasma throughput by as much as 700,000 liters.

As a result, Grifols will also ramp up production of its proprietary hemophilia therapies, immune globulins and albumin.

Human plasma is the source of over 700 proteins such as albumin, clotting factors, immunoglobulins, fibrinogen, which are used in the making of therapies that treat inherited rare diseases such as haemophilia, primary immune deficiencies, genetic emphysema, as well as shock, trauma, and burns. The bioprocess used to extract and purify these proteins is known as plasma fractionation.

Unlike traditional small molecule pharmaceuticals, the production of plasma therapies begins with the donation of human plasma which is then processed to extract specific therapeutic proteins, said Grifols, and can take seven-to-nine months.

Maintaining an adequate and readily available supply of plasma is essential to assuring continuous production of therapies, and is becoming more pertinent the US demand for biologics is set to grow over 11 per cent annually.

The company expects the validation and Food and Drug Administration (FDA) approval of the new "MiniFrac" facility will take around two years after which the new plant will be up and running.

"With growing demand for our life saving therapies in the US and around the world, we are now in a position to begin increasing our plasma fractionation capacity," said Victor Grifols, president and CEO of the company.

"Putting this additional capacity into service is one more step in the roll-out of our multi-year global growth strategy and is significant because it can be achieved by maximising the value of our existing assets."

Since 2002 the company has invested over $300m (€227m) in US production and logistics facilities, product licenses, and dedicated plasma collection operations.

Grifols added that this extra capacity will help produce 2.2m liters in the US, which, added to the 2.1m liters produced in Spain, makes a total of 4.3m liters of combined fractionation capacity for the two facilities.