Single-use filtration systems are increasingly replacing traditional stainless steel filter assemblies, piping, and tanks for purification and storage of bioprocess fluids in biopharmaceutical manufacturing. Unfamiliarity with polymeric materials and the need to ensure patient safety, however, have made extractables and leachables from these new components and systems a primary concern of process developers along with specialists in quality, validation, regulatory affairs, as well as agency reviewers. A general risk-based approach to determination of extractables and leachables from disposable bioprocess equipment…
Author Archives: Weibing Ding Jerold Martin
Implementing Single-Use Technology in Biopharmaceutical Manufacturing
In biopharmaceutical manufacturing, single-use components and systems can offer distinct advantages over reusable, cleanable systems. Deciding whether to move to a single-use approach, however, depends on many factors. In a recent review of biomanufacturers and CMOs, the risk of leachable materials entering drug products was highest on a list of end-user concerns, as shown in Figure 1 (1). That’s not surprising in view of the high organic polymer content of disposable components, a general inexperience with such polymeric materials in…