GE Healthcare’s Life Sciences business has announced that its chromatography media manufacturing facility and supporting functions in Uppsala, Sweden have been certified to ISO 22301, the international standard for business continuity management systems. Chromatography medium is a key component in the production of biopharmaceuticals such as insulin and monoclonal antibodies – vital medicines which help save the lives of millions of people.
The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent high-quality end product is dependent on the use of equally consistent, high-quality key manufacturing components.
GE Healthcare Life Sciences has taken extensive actions to help secure a continuous supply of media to the biopharmaceutical industry, and the achievement of ISO 22301 accreditation provides further assurance that the company has a robust program in place to maintain business continuity, even under the most unforeseen and challenging conditions.
Nigel Darby, GE Officer and Vice President, BioProcess, GE Healthcare Life Sciences said: “Security of supply and business continuity of these key manufacturing components is top of mind for our customers in the biopharmaceutical manufacturing industry. Being one of the first companies in the bioprocessing field to achieve ISO certification in business continuity reflects our commitment to minimizing risk and any potential impact of unforeseen disruptive incidents. We are actively working to certify our other BioProcess manufacturing sites to the ISO 22301 standard including single use technologies, cell culture media and BioProcess hardware.”
GE Healthcare Life Sciences simultaneously has announced a $100 million investment in its Uppsala facility to double manufacturing capacity for chromatography media by the end of 2018. The Swedish facility produces 250 different types of chromatography medium which are used in the purification of >90% of FDA-approved biopharmaceuticals, and employs around 1200 highly-skilled people in manufacturing, research and development, and other support functions.