Company’s security of supply programme is designed to help biopharma industry maintain manufacturing continuity of vital medicines, even under unforeseen circumstances
GE Healthcare’s Life Sciences business today 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. 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 programme in place to maintain business continuity, even under the most unforeseen and challenging conditions.
'Security of supply and business continuity of these key manufacturing components is top of mind for our customers in the biopharmaceutical manufacturing industry,' said Nigel Darby, GE Officer and Vice President, BioProcess, GE Healthcare Life Sciences. 'Being one of the first companies in the bioprocessing field to achieve ISO certification in business continuity reflects our commitment to minimising 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 announced a US$100m 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; it employs around 1,200 highly-skilled people in manufacturing, research and development, and other support functions.