Regulators Okay New Biotech Drug Purification Process from Pall ...
EAST HILLS, N.Y.--(BUSINESS WIRE)--March 10, 2004
Pall PALL - Peace and Long Life
PALL - Pressure Alarm Low Low (industrial control description) Corporation (NYSE: PLL) announced today that with collaborators from BioMarin Pharmaceutical Inc. (NASDAQ and SWX: BMRN) it will present data that demonstrate significant new advances in the safety and economy of protein purification. BioMarin is the first company to receive licensure from the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) for a drug product using a Pall dual membrane-based process, setting a new standard for biological purification in the industry. The new purification process eliminates the need for DNA testing and enhances removal of potential virus contaminants from protein-based drugs. The manufacturing step that incorporates the Pall Mustang(R) Q ion exchange ion exchange
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membrane was able to remove DNA to more than 100 million-fold below the level of detection, enabling BioMarin to insure the purity of Aldurazyme(R) (laronidase), an enzyme replacement therapy for the treatment of the genetic disorder mucopolysaccharidosis mucopolysaccharidosis /mu·co·pol·y·sac·cha·ri·do·sis/ (-sak?ah-ri-do´sis) pl. mucopolysaccharido´ses any of a group of lysosomal storage disorders due to defective metabolism of glycosaminoglycans, causing their accumulation and excretion and affecting the bony skeleton, joints, liver, spleen, eye, ear, skin, teeth, and the cardiovascular, respiratory, and central nervous systems. I. Following the appropriate testing and validation of this process step, BioMarin is exempt from batch release DNA testing. A reversible chemical reaction occurring between an insoluble solid and a solution during which ions may be interchanged, used in the separation of radioactive isotopes.
"BioMarin's findings set a new standard in the safety and purity of protein-based drugs," says Jerold Martin, Senior Vice President and Global Technical Director of Pall Life Sciences. "Pall Mustang Q membrane technology significantly reduces the possibility of a failed batch due to DNA contamination, an extremely costly problem with potential human health implications. Wide-scale adoption of Pall's purification process could lead to significant savings in drug production costs for biopharmaceutical companies," he added.
In addition to achieving a milestone in DNA clearance, BioMarin found that combining the Mustang Q membrane unit with the Pall Ultipor VF grade DV50 virus filter also significantly increased virus removal capacity and drug safety. The combined performance of these Pall products marks the first time two membrane-based technologies have been formally recognized by the FDA and EMEA as complementary methods of viral clearance in the manufacture of a licensed drug product. Both regulatory agencies stipulate the need for orthogonal At right angles. The term is used to describe electronic signals that appear at 90 degree angles to each other. It is also widely used to describe conditions that are contradictory, or opposite, rather than in parallel or in sync with each other. (independent) methods of viral clearance from protein drugs during manufacture based on the premise that different mechanisms of purification provide cumulative performance. The Ultipor VF DV50 filter removes viruses by size exclusion, while the Mustang Q chromatography membrane removes viruses by adsorption.
"Achieving this level of DNA and viral clearance is truly a breakthrough in manufacturing efficiency and cost savings for drug developers," Mr. Martin said. He will present a case study on this process "Orthogonal Membrane Technologies for Viral and DNA Clearance" with E.J. Brandreth, Director of Quality Assurance of BioMarin at the PDA SciTech Summit(TM) today.
Monoclonal antibody and protein-based drugs currently generate about $20 billion a year in treatments for debilitating diseases such as diabetes, multiple sclerosis and hemophilia. There are more than 370 biotech drugs and vaccines currently in clinical trials and another 3,500 in earlier stages of development.
In addition to Mr. Martin's presentation, a session entitled "Design and Validation Considerations for Single Use Systems" will be presented by Monica Cardona, BioPharmaceuticals Project Manager, Pall Corporation. at the PDA SciTech Summit on March 11.
About Pall Corporation
Pall Corporation is the leader in the rapidly growing fields of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, municipal drinking water, aerospace and broad industrial markets. Total revenues are $1.6 billion. The Company headquarters are in East Hills, New York with operations in more than 30 countries. Further information is available at www.pall.com.
Editor's Notes:
Pall speakers are available at booth #319 to discuss their presentations and new technologies at the PDA SciTech Summit, which takes place March 8-11, 2004 in Orlando, Florida at the Orange County Convention Center.
A photo of the Pall Mustang Q ion exchange membrane and the Pall Ultipor VF DV50 can be found on www.pall.com/pressroom
Aldurazyme was developed through a joint venture between BioMarin Pharmaceutical and Genzyme Corporation. Under terms of the joint venture, BioMarin manufactures Aldurazyme and Genzyme markets and sells Aldurazyme. Aldurazyme was granted marketing authorization by the FDA and the European Commission in Spring 2003 and has been available since May and June 2003 in the U.S. and the European Union respectively. Full product information for Aldurazyme is available at www.aldurazyme.com
Aldurazyme is a registered trademark of BioMarin/Genzyme LLC.