Emmanuel Abate, president genomic medicine and head of sustainability, Cytiva explores how bioprocessing leaders can protect patients, the planet, and their supply chain.
PFAS continues to draw heightened attention from regulators, customers, and the public. As proposals to restrict usage advance across global markets, the bioprocessing industry is being asked to demonstrate responsible stewardship, while ensuring uninterrupted access to essential therapies. The challenge is navigating an issue that is both scientifically complex and deeply operational. How do we advance environmental progress without disrupting the supply of lifesaving medicines?
The most practical path forward is grounded in science as not all PFAS carry the same level of risk. Effective PFAS management requires a risk-based approach that distinguishes between small molecular weight PFAS and the large, stable fluoropolymers widely used in controlled bioprocessing environments.
At Cytiva, our position is clear: environmental responsibility and reliable drug supply must go hand-in-hand.
Why differentiating PFAS matters
“PFAS” is a broad term that encompasses thousands of chemistries.
Historically, PFAS environmental and health concerns have centred on small molecule fluorine chemistries (8 carbons long, e.g. PFOA, PFOS), many of which are already restricted and have been eliminated as part of Cytiva’s manufacturing process.
By contrast, the fluoropolymers used in sterile bioprocessing, such as PVDF and PTFE, are high in molecular weight and are stable materials essential to ensuring the safety and consistency of modern biologics manufacturing. They enable sterilising grade filtration, reliable gas and vent filtration, and system integrity under harsh chemical and physical conditions.
To fully understand the environmental impact of fluoropolymer membranes, it’s important to look at the entire lifecycle of the material, starting with how the base fluoropolymer resin is made. While many fluoropolymer resins still depend on small, fluorinated chemicals, known as fluorosurfactants which require careful management, Cytiva’s PVDF resin does not.
Our PVDF suppliers have replaced these small molecule fluorinated chemistries with PFAS free alternatives that are more environmentally responsible. As a result, Cytiva’s fluorosurfactant-free PVDF membranes pose a significantly lessened environmental risk compared with other fluoropolymer membranes, such as PTFE, or hydrophobic PES gas filtration membranes, which often rely on PFAS based surface coatings to function. For this reason, when evaluating more sustainable alternatives, it is critical to confirm that they are genuinely low risk and supported by credible, PFAS free quality statements.
Although used in small volumes, certain specific PFAS uses contribute to critical operational characteristics and performance functions: a proportional approach must therefore be taken to protect the development of new therapeutic medicinal therapies, drug availability, and ultimately the patients we serve.
Lifecycle control is the foundation of responsible PFAS reduction
A responsible PFAS strategy requires a full lifecycle view: the chemistry used, how materials are manufactured, how they behave during use, and what happens at end-of-life.
Looking at bioprocessing overall, the life sciences industry uses a very small amount of these materials globally—roughly between 100 and 1,000 tonnes per year. This represents only a tiny share, around one hundredth to one tenth of one percent, of the 84 000 to 199 000 tonnes of polymeric PFAS introduced to the European Economic Area (EEA) market, as estimated by the dossier submitters to ECHA.
In biopharma manufacturing, these materials are used in highly controlled environments and have a long track record of safety. Extensive testing and regulatory oversight show they pose very little risk to patients. During normal use, exposure is minimal. At the end of their life, these materials can be safely destroyed through high temperature incineration, with very low emissions—using the same disposal methods and controls the biopharma industry already follows.
The low volumes, strict manufacturing standards, strong emissions and disposal controls support a more proportionate regulatory and operational approach.
Understanding regulators’ direction: toward proportionate management
Global regulatory scrutiny of PFAS is increasing, with reporting obligations live in Canada, some of the U.S. states, and various restriction proposals being considered, most notably in the EU and UK. The regulatory process is iterative and ongoing, so final rules are far from being finalised.
In the European Economic Area, the European Chemicals Agency’s (ECHA) universal PFAS restriction proposal generated significant concern because of its broad scope and potential impact on fluoropolymers essential to bioprocessing. Cytiva actively contributed to the public consultation and aligned with industry groups—including ASME BPE, BPSA, BioPhorum, and EFPIA—emphasising two principles:
- Higher molecular weight fluoropolymers used in small volumes in bioprocessing or industrial, closed system applications, combined with stringent Good Manufacturing Practices (GMP) and rigorous emissions controls are of low concern.
- Restrictions without socio-economic assessment could threaten global medicine supply, given the absence of viable alternatives in many applications.
Based on the current direction, several sectors, including sealing applications, machinery, and certain medical uses, are no longer included in ECHA’s risk or socioeconomic assessments (and March 2026 consultation). Excluding these uses from assessment signals they may fall outside the final restriction entirely. For life science uses that remain in scope, the draft EU proposal includes several derogations of up to 13.5 years, meaning we estimate most compliance deadlines to land around 2041 at the earliest. Products used in R&D and QC also remain exempt under REACH, minimising impact on early-stage development.
Together, these developments point toward a more balanced regulatory outcome—one that favours proportional, evidence-based controls over blanket prohibitions.
Science first, application first
PFAS reduction is achievable where equivalent materials exist. Many liquid filtration applications can successfully transition to PES or nylon membranes without sacrificing performance. Cytiva has over 35 years of experience with these membrane technologies, including sterilising grade and virus filtration.
However, some applications, especially sterile gas and vent filtration, require the hydrophobicity and thermal stability provided by PVDF or PTFE. Using non-equivalent designs can increase the risk of filter wetting, restricted airflow, batch failure, or unexpected downtime. These outcomes can produce more waste, more emissions, and more operational risk, undercutting the intended environmental benefit.
Industry assessments from BPSA, BioPhorum, and ASME BPE consistently reach the same conclusion: alternatives for PVDF in critical applications remain limited, and premature substitution could impose unnecessary cost and validation burdens.
The goal is not PFAS free at any cost but PFAS responsible, guided by scientific evidence and process risk.
Cytiva’s commitments to responsible stewardship
Cytiva is committed to meaningful PFAS reduction, focusing on transparency, risk mitigation, and operational continuity. Our stewardship actions include:
- Proactively phasing out small molecule PFAS that are not restricted today (< C16 ) from products and processes.
- Ensuring all PVDF membrane production is fluorosurfactant-free.
- Collaborating with suppliers to identify PFAS free alternative options for long lead time components, such as O-rings in ReadyToProcess column.
- Supporting customers global reporting obligations across the U.S., Canada, Australia, and EU.
- Engaging regulators to ensure restrictions do not disrupt the supply of life-saving therapies.
Our objective is simple: reduce environmental impact while safeguarding the reliability of drug manufacturing and supply.
What bioprocessing leaders should prioritise in 2026
To prepare for the next phase of PFAS regulation, bioprocessing leaders should:
- Map PFAS relevant materials across their operations and supply base.
- Prioritise reductions in high risk, small molecule PFAS.
- Evaluate lifecycle controls, including supplier emissions and waste handling.
- Request transparency behind “PFAS-free” claims.
- Engage early with suppliers to stay ahead of regulatory shifts.
Looking ahead
PFAS regulation will continue to evolve, and innovation toward PFAS free materials will accelerate. But progress must be grounded in science, not alarm. By focusing on high impact risks, maintaining constructive regulatory engagement, and collaborating across the value chain, our industry can protect the planet and the patients who depend on lifesaving therapies.
Cytiva remains committed to clarity, responsibility, and leadership as we navigate this transition together.