The Role Of BioPhorum Extractables Data In The Effective Adoption Of Single-Use Systems

By Jessica Shea, Program Manager, Emprove® Program, MilliporeSigma

The use of single-use systems is increasing in biomanufacturing due to their significant advantages in enhancing efficiency and productivity, particularly in processes like final filtration, mixing, and aseptic connections. These systems can lower capital investments in facilities and equipment, eliminate the need for cleaning and validation procedures, reduce startup times, and minimize the risk of cross-contamination. Additionally, they offer more reliable lead times and enable the faster delivery of higher quality, more cost-effective products.

However, single-use systems also come with potential risks. The polymeric materials used in these systems can introduce various unwanted chemicals into the process fluid. Substances such as styrene monomers, stabilizers, lubricants, slip agents, pigments, and antioxidants like BHT may either leach out of the system or be extracted by solvents utilized during manufacturing. To ensure patient safety, biomanufacturers must carefully evaluate and manage the risks associated with extractables and leachables (E&L) in these systems. The challenge of obtaining E&L data and managing associated risks is a primary reason why some researchers are hesitant to adopt single-use systems. Continue reading to explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.