Regulators OK Pall biotech drug purification process

MARCH 16–EAST HILLS, N.Y. Pall Corp. and BioMarin Pharmaceutical Inc. has completed data that will 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, paving the way for 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 mucopoly-saccharidosis.

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 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 (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.


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