Pall gets OK for purification process

Related tags Dna Pall

Pall has been granted European Union and US approval for a
purification process used in biopharmaceutical production that can
reduce the batch testing requirements of manufacturers, as well as
reducing the risk of virus contamination.

The dual membrane separation process has been approved as part of the marketing application for BioMarin Pharmaceuticals' Aldurazyme (laronidase), an enzyme replacement therapy for the treatment of the genetic disorder mucopolysaccharidosis I.

The main benefit of the process is that it reduces the chances that protein products are contaminated with DNA from the cell culture medium in which they are synthesised. Strict regulations mean that DNA must not be detectable in production batches, for fear that it may have consequences on human health. If it is, the entire batch is unusable which is expensive for the company and could mean treatment shortages for patients.

The manufacturing step that incorporates the purification process - based on Pall's Mustang Q ion exchange membrane - was able to remove DNA to more than 100 million-fold below the level of detection. As a result, BioMarin will no longer have to carry out DNA testing on its product batches, saving time and money.

"Wide-scale adoption of Pall's purification process could lead to significant savings in drug production costs for biopharmaceutical companies,"​ commented Jerold Martin, global technical director of Pall Life Sciences.

The process, which also includes the use of Pall's Ultipor VF grade DV50 virus filter, also reduces the chance of viral contamination compromising the safety of biological drug products, according to the company.

Use of the two filters in tandem, one of which gets rid of viruses by adsorption and the other by size exclusion, which complies with the US and EU regulators' position that virus filtration using more than one method should be included in biologics production.

Monoclonal antibody and protein-based drugs currently generate about €16 billion a year in treatments for diseases such as diabetes, multiple sclerosis and haemophilia. There are more than 370 biotech drugs and vaccines currently in clinical trials and another 3,500 in earlier stages of development.

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