High manufacturing capacity with consistent product quality

GE Healthcare has one of the world’s largest manufacturing capacities of bioprocess chromatography media. The manufacturing site is certified according to ISO 9001:2008 and consists of two physically separated multipurpose manufacturing facilities.

Capacity

GE Healthcare produces over 300,000 L chromatography media annually. We continuously expand our manufacturing capacity. During the coming years we will invest >100 MUSD to significantly increase our manufacturing capacity for our Capto and MabSelect family platform Our scale of production allows us to quickly adjust to increasing customer needs.

Discontinuation policy

Long-term supply of chromatography media is equally important as short-term supply. We are dedicated to supplying each BioProcess chromatography media for as long as the products are knowingly used in approved, registered manufacturing processes for human therapeutics. This provision is formalized in a discontinuation policy signed by the CEO of GE Healthcare Life Sciences.

Safety stock offering

We offer our customers the possibility of having a safety stock. The safety stock is a customer-dedicated inventory, held by GE Healthcare for a monthly fee to minimize downtime or product loss caused by incidents at customer sites during regular production or a manufacturing campaign.

To safeguard production for the future, a business continuity plan (BCP) is implemented at our manufacturing site. The plan identifies and evaluates risks to critical assets, and mitigates the effects of unforeseen losses by having in place continuity and recovery strategies, developed at both corporate and business levels.

In 2015 the GE Healthcare chromatography media manufacturing site was certified to ISO 22301:2012 "business continuity management" as one of the first companies in the biopharmaceutical industry.

In case of an incident that severely affects GE Healthcare’s manufacturing of chromatography media, a strategic reserve of media has been established to cover for deliveries during the business recovery phase. The reserve comprises media used in approved and registered manufacturing processes of human therapeutics. This back-up inventory covers approximately 6 to 12 months’ supply, depending on the recovery plan for each product, until manufacturing is up and running according to our business continuity plan.

The strategic reserve consists of more than 80 000 liter of chromatography media representing more than 70 products. It is kept in locations in Europe and USA geographically separated from our manufacturing site.

At GE Healthcare, we require that all our suppliers have a quality management system in place corresponding to ISO 9000 or equivalent. Our suppliers are audited on a regular basis by trained and qualified supplier quality engineers. Other important requirements are: a supplier quality agreement, detailed information on financial status, compounds subjected to regulations such as REACH and components of animal origin, and a supplier business continuity plan.

Should a severe incident happen in our own supply chain, we can make use of our strategic reserve to cover for potential supply interruptions to registered manufacturing processes. In addition, we have identified at least one second supplier for most of our critical and important raw materials to reduce implementation time if required during an emergency.