Key Points:
PFAS are persistent chemicals used in drug formulations for their beneficial properties but pose environmental and health risks due to their resistance to degradation and potential contamination of drug products.
There is increasing global regulatory scrutiny on PFAS, requiring the pharmaceutical industry to understand, monitor, and mitigate PFAS contamination in products and manufacturing.
Advanced technologies like liquid chromatography-mass spectrometry (LC-MS) are improving the detection of PFAS in pharmaceuticals, supporting regulatory compliance and enhancing safety, as highlighted by insights from Jon Bardsley of Thermo Fisher Scientific.
Per- and polyfluoroalkyl substances (PFAS), often dubbed "forever chemicals," have emerged as a significant concern in pharmaceutical formulation and manufacturing due to their unique chemical properties and persistence in the environment. PFAS are commonly used for their hydrophobic and lipophobic characteristics, which can improve the stability, bioavailability, and solubility of certain drug formulations. However, their chemical stability also means they resist degradation, leading to accumulation in both the environment and the human body.
In the pharmaceutical industry, PFAS can inadvertently contaminate drug products through equipment, packaging materials, or excipients. This contamination poses potential health risks, including endocrine disruption, immunotoxicity, and carcinogenicity, which may undermine patient safety. Moreover, regulatory scrutiny of PFAS is intensifying, with agencies worldwide setting stricter limits on their use and discharge.
Thus, understanding and mitigating PFAS contamination is crucial to ensure compliance with evolving regulations and to protect human health. The pharmaceutical industry must adopt proactive measures to identify, monitor, and reduce PFAS presence throughout the drug development and manufacturing lifecycle.
Fortunately, newer and more advanced technologies have enabled scientists to dive deeper into PFAS screening, allowing for higher quality results, increased confidence and reproducibility, as well as regulatory compliance in the pharmaceutical manufacturing process. LCGC International spoke to Jon Bardsley, marketing development manager for pharmaceuticals and biopharmaceuticals at Thermo Fisher Scientific regarding the advancement of PFAS detection in pharmaceutical manufacturing with liquid chromatography-mass spectrometry (LC-MS).In the first of our three-part presentation, Bardsley discusses the influence of regulations for PFAS in the pharmaceutical and biopharmaceutical industry.
