October 18-21, 2015
Application of single-use technologies in biopharmaceutical manufacturing can be driven by several factors such as reduced capital costs, reduced risk of cross-contamination, increased process flexibility, and reduced cleaning validation. However, implementation of single-use technologies have been restricted due to a number of concerns, with the most commonly cited being the presence of extractables and leachables (E/L) from single-use technologies. In general, overly conservative estimates of E/L are used in the risk assessment due to lack of data on clearance, resulting in a time-consuming, costly, and extensive E/L assessment for single-use technologies.
A proof-of-concept study is presented here to simplify these E/L assessments for qualification and implementation of single-use technologies in biopharmaceutical manufacturing. Results from the study indicated clearance of defined E/L in protein solutions. However, unexpected clearance phenomena were observed for specific groups of E/L, which will be discussed in detail.
Kate Lee, Nicholas Magarian, Kunal Nagpal, Ekta Mahajan, and Kenneth Skidmore, "Headache be gone: Clearance of extractables and leachables in single-use technologies through ultrafiltration/diafiltration" in "Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications", Ekta Mahajan, Genentech, Inc., USA Gary Lye, University College London, UK Eds, ECI Symposium Series, (2015). https://dc.engconfintl.org/biopoly/7