WHITEPAPER

Resin Sourcing

Many biopharmaceutical processes are maturing, and manufacturers are seeking to make modifications and improvements to those processes as market forces exert greater pressure on costs. At the same time, there have been considerable advances in processing technology and there are opportunities to create value and reduce costs by incorporating those technologies. Finally, some of the new technologies show performance comparable to current industry standards and there is the opportunity to reduce the risk of reliance on a single source for critical materials.

This paper, authored by independent experts Duncan Low and Brian Hubbard, discusses the regulatory pathways for introducing process improvements and/or alternate sources of chromatography resins, and provides selected examples of the approaches taken by different manufacturers.