GE Healthcare manufacturing facility in Lindesnes, Norway
As part of the security of supply program for BioProcess resins, the production of the cellulose-based chromatography resins DE52, CM52, DE32, and CM32 is now transferred to our global supply chain manufacturing site in Lindesnes, Norway.
GE Healthcare has taken action to maintain product quality of the Whatman cellulose-based ion exchange chromatography resins and enabled a continued supply of these products with high quality and performance.
Manufacture in our modern facility in Lindesnes, Norway, will enhance control of the manufacturing process and potentially reduce variation in the performance characteristics of these chromatography resins.
We are happy to announce the phase out of the controlled order intake process for the cellulose-based Whatman chromatography resins. On 1 Oct. 2015 and 15 Dec. 2015, the controlled order intake was removed for DE52 and DE32, respectively. On 20 Jun. 2016, the controlled order intake for CM52 and CM32 was removed. We now have free sale of validated DE52, CM52, DE32, and CM32 products manufactured in Norway.
With the internal transfer, a new modern facility within the Lindesnes site in Norway is introduced with comparable manufacturing equipment, manufacturing methods, test methods, and analytical specifications. The analytical specifications have been streamlined between products and, for example, the parameter flow rate is added to the analytical specifications.
Based on a thorough internal technical transfer program, results from comparability studies and process validation, we conclude that DE52, CM52, DE32, and CM32 products manufactured in Lindesnes, Norway, can replace products manufactured in Maidstone, UK and can be supplied under the same product codes.
Cotton linter is the critical raw material for GE Healthcare Life Sciences cellulose-based chromatography resins products. For a sustainable supply of Whatman chromatography resins, a new supplier manufacturing site for cotton linter was qualified in 2013, in accordance with GE Healthcare's quality management system.
Based on the results obtained during GE Healthcare's process qualification and additional analyses, it was concluded that the products DE52, CM52, DE32, and CM32 based on cotton linter from the new manufacturing site, were interchangeable with products based on cotton linter from the former manufacturing site and, hence, they could be supplied under the same product codes.
Because of decreasing demand and/or technical challenges, the products CDR, CM23, CM92, DE23, DE53, DE92, Express-ion C, Express-ion D, Express-ion Q, Express-ion S, P11, P11S, QA52, and SE53V have been discontinued by GE Healthcare.
Information about the discontinuation of these products has been published and is available to customers of BioProcess products that have subscribed to our change control notifications via our regulatory support application.
We regret any inconvenience that this discontinuation may cause and look forward to supporting you with finding alternative chromatography resins for your applications.
The rights to the P11 and P11S cellulose phosphate product lines have been acquired by Thermo Fisher Scientific.