What are PFAS and how do they impact the biotech industry?

The persistence of forever chemicals in the environment is a major environmental and healthcare challenge. Some fluorinated chemicals that come from a variety of plastics and elastomers, are now known to be harmful to health and exposure can lead to wide range of problems such as decreased fertility, liver damage and cancer. So, it should be no surprise that the controls necessary to stop these from entering the environment at all stages of the product life cycle are the subject of many conversations and regulations. Increased restrictions on their use are highly likely, but how will this impact the pharmaceutical industry?

What are PFAS?

A per- and polyfluoroalkyl substance (PFAS) refers to a broad range of thousands of fluorine-containing organic chemicals that have at least one fully fluorinated methyl or methylene group. They include both small molecules and very large, cross-linked polymers. Regardless of their molecular weight, the strength of the carbon-fluorine bonds makes them resistant to degradation and are used in many different industries that value the resistance to chemical attack in the finished material. This same characteristic leads to their description as 'forever-chemicals', a reminder that this stability causes them to persist in the environment for thousands of years and accumulate.

They can already be found in our air, our soil, our water and even in our blood. With this knowledge, some chemicals have already been phased out, but we are still using others. These persistent organic pollutants (POPs) are now the subject of much discussion with the European Chemicals Agency (ECHA) and UK considering restrictions. There is little doubt that their continued use without strong controls will continue to harm our environment, and in turn, us.

Two of the most the well-known PFAS chemicals have been in commercial production since the 1940's and have now been phased out of production. Perfluorooctane sulfonate (PFOS) and perfluorooctanoidc acid (PFOA) were used in a wide range of applications including non-stick cookware, cleaning products and fire-fighting foams. Since the bans, in 2002 and 2015 respectively, PFOA has now been classified as a human carcinogen and PFOS as a possible carcinogen. This knowledge focuses the attention on the impact of similar chemicals.

The pharmaceutical industry is critical to global health. It is accustomed to operating in a way that ensures the safety or patients and operators. Through regulation, it is expected to understand, minimize and control risk to the patient. It is also largely committed to functioning in a way that is sustainable and that improves lives. This would seem to make it naturally supportive of a restriction but, how would the pharmaceutical industry need to adapt if a complete ban were to come into force? Removing these chemicals and materials without functional alternatives may cause significant challenges to an industry that has come to rely upon them to produce the drugs and therapies that treat those that need them.

Where can I find PFAS in bioprocessing?

A number of materials used in a typical bioprocess contain PFAS. A selection of materials and common applications can be found below.

In 2023 the ISPE conducted a survey investigating the impact of the proposed PFAS restriction on the production and packaging of active pharmaceutical ingredients, drug substances, drug products and excipients. 100% of responders with drug manufacturing facilities based in the EU were concerned about the potential impact of PFAS restrictions. The range of concerns included applications such as container closures, packaging materials and single-use production equipment including filtration and tubing.

This is perhaps unsurprising when many materials used in specialized applications do not currently have obvious PFAS-free alternatives. Given that developing and implementing viable alternatives may take a decade or more, what does the pharmaceutical industry do to meet its own environmental and sustainability objectives while servicing the healthcare needs of the populations that they serve?