March 8, 2014

Security of Supply for Chromatography Media

The complex nature of biopharmaceuticals makes manufacturing a challenge, because a consistent, high-quality end product is dependent on the use of equally consistent, high-quality key manufacturing components.
Key manufacturing components are often single-sourced, which are costly and time-consuming to replace—and considering that a biopharmaceutical can have a lifetime of 30 years or more, a reliable, long-term supply of key manufacturing components is essential.

Chromatography medium (resin) is a good example of a key manufacturing component. Being one of the world’s leading suppliers of chromatography media, GE Healthcare Life Sciences has taken extensive preventive actions to help secure a continuous supply of media to our customers. We have implemented a security of supply program to help our customers maintain manufacturing of vital biopharmaceuticals, even under unforeseen circumstances.

This white paper addresses GE’s approach to maintaining a secure supply of chromatography media.

Tags: continuity of supply, quality, sourcing, process development, emergency preparedness, safety stock, manufacturing, disaster recovery, security of supply, supply security, supply