Grifols has been working in the fields of bioscience and diagnostics for more than 60 years. Since the companys pioneering work in plasmapheresis, it is now a third-generation family enterprise that still holds true to its heritage of innovation, quality and safety.
Grifols, a global biopharmaceutical leader, has established its presence in the United States since 2003. The manufacturing, testing, and shipping facilities in Los Angeles augment Grifols state-of-the-art operations in Barcelona, thus increasing its worldwide capacity and reach. The company manufactures and distributes plasma derivatives, diagnostic equipment, reagents and automated drug dosing systems. The Grifols family of products is divided into three divisions: Bioscience, Diagnostic and Hospital.
The Bioscience Division is responsible for plasma-based derivatives and has just launched Flebogamma® 5% DIF (Dual Inactivation and Filtration), an intravenous immune globulin (IVIG). Since the introduction of their first-generation IVIG product, Flebogamma® 5%, internationally in 1993 and in the United States in 2003, it has become one of the worlds leading IVIG products, with licenses in more than 30 countries and over 30 million grams sold worldwide.
In addition to the pasteurization process used in the first-generation product, Flebogamma 5% DIF also utilizes solvent detergent treatment and dual sequential nanofiltration (35 nm and 20 nm). Flebogamma 5% DIF remains a liquid product that can be stored at room temperature and is ready for immediate use. It is FDA-approved for the treatment of primary immune deficiency. To illustrate Grifols ongoing commitment to safety, each vial of Flebogamma is laser etched with the lot number and a filling sequence production number. This filling sequence identifying number allows Grifols to reference a video of a particular vial being filled, if needed. It also allows for easier tracking of individual vials, in addition to deterring tampering.
For the treatment of hemophilia, Grifols supplies Alphanate®Antihemophilic Factor, AlphaNine® SDCoagulation Factor IX, and Profilnine® SDFactor IX Complex. Affinity chromatography column purification is used to produce high-purity Alphanate and AlphaNine. Furthermore, all products are treated with one or a combination of viral inactivation methods including solvent detergent, heat and nanofiltration. As for Grifols current portfolio of coagulation concentrates sold in the United States, more than 390 million units of AlphaNine SD, 664 million units of Alphanate and 125 million units of Profilnine SD have been used without a documented case of viral transmission. For added safety, each vial is laser etched with the lot number to deter tampering.
All Grifols Bioscience products sold in the United States are made from 100% sourced U.S. plasma. To help meet demand, Grifols operates more than 70 plasma donation centers throughout the country. All plasma collection centers adhere to the International Quality Plasma Program standards and all manufacturing facilities meet the Quality Standards of Excellence Assurance Leadership, a program developed by the Plasma Protein Therapeutics Association. Therefore, from donor to patient, Grifols controls its entire plasma therapy production process.
Diagnostic and Hospital Divisions
The Triturus® System, which is manufactured and distributed by the Diagnostic Division, is a first choice for laboratories worldwide when performing automated enzyme-linked immunosorbent assaybased diagnostic tests. The Hospital Division has the Gri-fill® System, an innovative, automated, drug-dosing system that enables pharmacists or technicians to compound and prepare individualized I.V. doses within a closed sterile system outside of the laminar flow hood. Both systems are good examples of the many state-of-the-art systems developed by Grifols.
Future Grifols product developments include a new indication for use in von Willebrand disease for Alphanate (to be launched soon), Antithrombin-III and Fibrin Glue. As part of its ongoing commitment to quality and safety of its products, Grifols engineering department, which has designed and manufactured machinery for other biopharmaceutical production plants around the world, has been improving the Los Angeles production facility and has invested more than $12 million since 2003. Consequently, efficiency and increased plasma derivative refinement will also result from the recent and planned ongoing improvements.
Grifols is fast securing a reputation as a trusted source of plasma-derived products. Despite plasma product shortages and high pricing, Grifols has done its best to provide a consistent supply while honoring contractual pricing below open market pricing. Gregory Rich, president and CEO of Grifols, Inc., in the United States, stated: We at Grifols are proud of our supply and pricing record because it exemplifies our ultimate commitment to the people and patients who rely on our products.