October 18-21, 2015
There is a growing interest from the end-user community in creating supply chain transparency as it pertains to critical raw materials used within their pharmaceutical manufacturing processes. Single-use systems contain mainly polymeric materials, often in diverse combinations drawing from a wide range of thermoplastic and elastomeric resins. Continued adoption of single-use assemblies into the entire spectrum of unit processing and production operations has led to increased scrutiny thereof and consequently many end-users have strengthened their technical diligence teams to include material scientists. These SME’s are tasked with enhancing the understanding of the materials of construction utilized in single-use systems. Their focus often goes beyond the basic resin formulations to include discerning the impact of a material’s processing signature on leachable profiles, and ultimately to understanding associated process variability and/or potential impacts to patient safety.
Employing material science as an integral part of an overall quality-by-design approach to single-use product development has proven to be incredibly useful in addressing potential leachables in single-use products, which may have otherwise contributed to enhanced process variability or even failure. This presentation will provide several case studies in the application of material science and forensic analysis of extrusion processes in the development of single-use products to mitigate the risk of unexpected leachables.
Christian Julien, "Material science enabled quality by design: The new standard in SUS development" 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). http://dc.engconfintl.org/biopoly/29