Bioprocesses at risk from proposed ‘forever chemicals’ regulations

Experts are calling on industry to respond to proposed rules restricting perfluoropolymers – commonly considered ‘forever chemicals’ – which are used in virtually all biomanufacturing processes.

The European Chemicals Agency (ECHA) is looking to implement a series of restrictions on the manufacture, placing on the market, and use of per- and polyfluoroalkyl substances (PFAS). Multiple other jurisdictions are also proposing similar restrictions.

“Virtually all bioprocesses for biotherapeutics and vaccine manufacturing depend somewhere in the process on these materials, which include the unique chemical compatibility properties of polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), and oleophobic air filtration membranes,” James Dean Vogel, founder and director of The BioProcess Institute, and James Hathcock, senior director of Regulatory and Validation Strategy at Pall Biotech, write in a call-to-action sent to this publication.

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“These, and other specialty materials, are used to ensure the sterility and purity of the drug product, which is required by law.”

According to the ECHA, perfluoropolymers are increasingly detected as environmental pollutants and many are linked to negative health effects. The substances contain carbon-fluorine bonds, one of the strongest chemical bonds in organic chemistry, which means they resist degradation.

“While these regulations are well-intended to eliminate thousands of ‘forever chemicals’ that have generated a bona-fide environmental health risk, they also represent the broadest restrictions ever proposed by ECHA, covering many chemicals and materials assessed as low toxicity potential and used in critical pharmaceutical and medical applications,” say Vogel and Hathcock.

“Whereas special treatment under ECHA is allotted for critical materials used in medical devices, food packaging, and aerospace, these derogations only serve to extend the elimination date out to a maximum of 13.5 years, which is a remarkably short time to trust that suitable alternative materials will be understood, developed, and implemented.

“Moreover, the proposed derogations do not currently include the materials mentioned which are critical to pharmaceutical manufacturing.”

“With a pending six-month public consultation period for the ECHA regulations starting March 22, 2023, all those vested in critical patient therapies relying on these technologies need to quickly engage and make regulators aware of the impact to patients and our industry.”

More information regarding the proposes ruling will be divulged during an online ECHA consultation webinar taking place on Wednesday April 5 at 10am CET (4am ET).

To submit comments to the ECHA during the consultation period, click here.