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Key manufacturing components are often single-sourced. As it can be costly and time-consuming to replace components of a regulated biopharmaceutical manufacturing process, it is important to secure the supply of these components.
A consistent, high-quality end product is dependent on the use of equally consistent, high-quality key manufacturing components. Considering that a biopharmaceutical can have a lifetime of 30 years or more, reliable, long-term supply of key manufacturing components is essential.
Cost for supply interruption of a blockbuster
biopharmaceutical can be as much as
1 and 10 MUSD/day. Find out more
Chromatography medium is an example of a key manufacturing component. Being one of the world’s leading suppliers of media, GE Healthcare Life Sciences has taken extensive preventive actions to help secure a continuous supply of chromatography media. We have implemented a security of supply program to help our customers maintain manufacturing of vital biopharmaceuticals, even under unforeseen circumstances.
Our security of supply for chromatography media is a three-part supply program to meet your demand for security of supply for chromatography media:
Consistent Supply: We have a high manufacturing capacity of products with consistent quality to meet your security of supply needs for fast and predictable deliveries both short- and long-term.
Emergency Preparedness: We minimize the probability and potential impact of a serious incident at our manufacturing site. Our emergency preparedness program includes an extensive business continuity plan (BCP) following industry standards and a strategic reserve to enable delivery of chromatography media for use in biopharmaceutical manufacturing during business recovery.
Supply Chain Sustainability: Our rigorous standards for supplier qualification and management, a second supplier program, and inventory management minimize the risk of supply shortages of critical raw materials needed for production of our chromatography media.
Manufacturing of chromatography media at the Uppsala site
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.
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.
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.
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.
Emergency preparedness for chromatography media with respect to finished goods and critical and important raw materials. Left bar: Percent of GE Healthcare’s chromatography media used in approved and registered processes covered by the strategic reserve. Right bar: Fraction of critical or important raw materials, used in production of chromatography media, for which second suppliers are identified or implemented.
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