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Security Of Supply For Chromatography Media

Source: GE Healthcare Life Sciences

The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

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Key manufacturing components are often single-sourced.As it many times is costly and time-consuming to replace components of a regulated manufacturing process, it is important to secure the supply of these components. Considering that a biopharmaceutical can have a lifetime of 30 years or more, reliable, long-term supply of key manufacturing components is essential.

Chromatography medium (resin) is an 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.

In view of today’s complex global supply chains and recent years’ financial turmoil and natural disasters, such as the volcanic eruption on Iceland in 2010, the earthquake and tsunami in Japan in 2011 (Fig 1), and hurricane Sandy that hit the US east coast in 2012, we are reminded of how vulnerable today’s supply chains can be to unforeseen events. As the end products are intended for the treatment of millions of patients with serious and life-threatening diseases, actions to avoid disruptions in the supply chain need to be in place for the manufacturing of biopharmaceuticals.

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