Grifols announced availability of its recently approved Flebogamma 10% DIF intravenous immune globulin. Grifols is a global healthcare company specializing in bioscience medicines derived from human plasma. Approval from the US Food and Drug Administration (FDA) for Flebogamma 10% DIF was obtained in July 2010 and final approval in Europe is expected before the end of the year. Today's announcement signals widespread product availability to the US market.
"We are excited about being able to meet a wider range of clinical needs by providing healthcare providers and patients the additional treatment option of Flebogamma 10% DIF," said Gregory Rich, president of Grifols' US operations. "Grifols understands that the clinical needs of patients are unique and by offering a choice of IVIG concentrations we can better address them," continued Rich.
The approval and launch of Flebogamma 5% DIF in early 2007, ushered in a new standard in IVIG treatment with the development of a dual inactivated, nano-filtered (DIF) product. Like Flebogamma 5% DIF, the new 10% solution has two distinct pathogen inactivation processes (heat treatment and solvent detergent) and a proprietary 20 nanometer filtration step. The manufacturing process for Flebogamma DIF is also very efficient at eliminating extraneous proteins, resulting in a high purity IVIG solution (99.4% IgG). Development of the DIF production process was the result of more than a decade of research and the construction of dedicated, state-of-the-art IVIG production facilities in Barcelona, Spain. A twin production facility has been under construction in Los Angeles since 2008, and expected to be completed in 2013. For the time being, Grifols' Flebogamma 10% DIF will be produced exclusively at its Barcelona facility.
"I commend Grifols on their commitment to the development of additional treatment options," said Marcia Boyle, president and Founder of the Immune Deficiency Foundation, the national patient organization for persons with primary immune diseases. "New products help assure continued access to this lifesaving medicine so that countless people who live with primary immunodeficiencies, such as my son, can lead healthy and productive lives," continued Boyle.
Like all Grifols' products, each vial of Flebogamma 10% DIF is laser etched with a unique identification number to ensure product integrity. In addition, the outer packaging is secured with a tamper evident holographic overseal containing specialized printing to confirm authenticity. Grifols also offers healthcare providers access to a proprietary web-based system called PediGri that provides full traceability for every plasma donation used to produce an individual product vial.
Grifols has a wholly owned dedicated engineering division (Grifols Engineering) that develops state-of-the-art manufacturing suites for the biologics industry. The design concepts used in the Flebogamma 5% DIF and Flebogamma 10% DIF production facility were developed exclusively by Grifols Engineering and include such things as minimal exposure zones to reduce manufacturing surface areas and the potential for microbial contamination. Process enhancements achieved by the use of newer technologies and Grifols' proprietary process design concepts result in an increase in the amount of IVIG that can be obtained from each plasma donation.
Grifols S.A. is a Spain-based healthcare company engaged in the research, development, manufacturing and marketing of plasma therapies, IV therapy solutions, enteral and parenteral nutrition, diagnostic systems, pharmacy automation, and medical materials and devices.