Grifols receives FDA approval for its new purification plant to produce Gamunex in Los Angeles


02.01.2015

  • The plant, located in Los Angeles (California), represents an investment of 53 million euros, and over 100 new jobs will be created when it starts operation in 2015
  • The plant has a total area of 9,000 m2 and a purification capacity of 17 million grams of immunoglobulin per year
  • Immunoglobulins are among the most important and widely consumed plasma proteins, and are indicated in the treatment of primary immunodeficiencies and some secondary immunodeficiencies, and also for neurological diseases

Barcelona, January 2, 2015: Grifols (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS), a leader in the production of plasma-derived medicines, has received approval from the US Food and Drug Administration (FDA) for its new plant for the purification of intravenous immunoglobulin (IVIG) 10%, the most important and widely consumed plasma protein, which the company markets under the Flebogamma® and Gamunex® brands.

The new plant forms part of Grifols' industrial complex in Los Angeles (United States) and represents an investment of 53 million euros. The plant has a total area of 9,000 m2 and a purification capacity of 17 million grams of immunoglobulin per year, increasing the manufacturing capacity for Gamunex®. The company expects the new plant to come on stream in 2015, as scheduled, and to lead to the creation of over 100 new jobs.

The facilities were designed by Grifols Engineering S.A., a Grifols company specializing in engineering pharmaceutical and biotechnology processes. The plant incorporates the very latest equipment, to ensure that the purification process for this plasma protein is characterized by the highest levels of safety, quality and efficacy.

In addition, the plant has cutting edge technology to reduce the environmental impact of its activity by reducing the use of water and energy.

About intravenous immunoglobulin (IVIG) and protein purification

Once the plasma has been fractionated or separated, each of the proteins obtained must be purified and undergo a rigorous process to inactivate any infectious agents before the filling stage.

The new plant, approved by the US health authorities (the FDA) will be dedicated exclusively to the purification of IVIG.

IVIGs are the most important and most widely consumed plasma proteins. This purified plasma fraction contains the antibodies that provide the body with its antibodies or immune defenses, and for this reason it is indicated in the treatment of primary immunodeficiencies and some secondary immunodeficiencies, and also for neurological diseases.

Grifols markets its IVIG under the Flebogamma® and Gamunex® brands, and has the first and only IVIG approved in the United States and Canada to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder characterized by progressive weakening and deterioration of sensory function in the arms and legs. It is also registered in the United States for subcutaneous use in the treatment of primary immunodeficiencies.

Grifols will allocate more than 600 million euros to the construction of new facilities between 2014 and 2016

Grifols' presence in the United States is firmly established. In 2013, sales in North America generated 1.708 billion euros, a figure that represents 62.3% of the company's turnover.

The United States is also one of the major targets of Grifols investment. Since 2001 the company has invested over 7 billion dollars in the country, a figure that includes both capital expenditure (CAPEX) and strategic acquisitions, as a result of which it accounts for 20% of the global market in plasma proteins and is a leader in other, complementary business areas such as transfusion diagnostics.

Grifols' strategic organic growth plan continues to progress with new investments in manufacturing facilities both in Spain and in the United States. Grifols plans to allocate more than 600 million euros to capital expenditure between 2014 and 2016.

A significant portion of this investment plan will provide funds for expanding the albumin purification plants in Los Angeles (California) and Clayton (North Carolina), a new warehouse at the Clayton industrial complex and a logistics center in Dublin (Ireland), while the construction of a new alpha-1-antitrypsin purification plant at the Parets del Vallès complex (Barcelona) is one of its most important projects in Spain.

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