Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry

Abstract

AbstractSingle‐use technology has been adopted widely in bioprocess development and biopharmaceutical manufacture in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractables and leachables arising from the components of single‐use systems owing to their potential effect on product quality and patient health. Their impact on drug product quality and safety must be clearly understood before adopting disposable technologies into manufacture. A risk assessment is normally required to assess the probability of extractables and leachables migrating into the product stream and their potential risk to the patient. Generic information provided by suppliers may be useful but its relevance to individual applications needs to be demonstrated. Standardization of extractables and leachables testing and approaches to risk assessment has been discussed between the biopharmaceutical industry and regulators. This perspective reviews the current status of extractables and leachables studies within the biopharmaceutical industry and the general approaches employed for risk evaluation associated with the application of single‐use technology. © 2015 Society of Chemical Industry