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RSSRegulators Okay New Biotech Drug Purification Process from Pall that Enhances Safety and Eliminates DNA Testing
March 11, 2004
East Hills, NY (March 10, 2004) - - Pall 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® Q ion exchange 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® (laronidase)! , an enzyme replacement therapy for the treatment of the genetic disorder mucopolysaccharidosis I. Following the appropriate testing and validation of this process step, BioMarin is exempt from batch release DNA testing."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(R) 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 (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™ 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, BioPharm Project Manager, Pall Corp. at the PDA SciTech Summit on March 11.
