GE Healthcare announced the acquisition of PAA Laboratories in August 2011. We have been working diligently on the ongoing integration of these products into our broader Life Sciences portfolio. In the near future, you will be able to find our high quality cell culture products on the GE Healthcare Life Sciences Web site.
Please see below for specific information about changes we have implemented as part of the integration process.
If you have any questions or require further information, please contact your local GE Healthcare representative.
GE Healthcare will be changing the intended use statements on all cell culture media and reagent products to “For Research or Further Manufacturing Use only. NOT for use in Animal or Human Diagnostic or Therapeutic Application”. For clarification, this statement points out that the products are not suitable for “direct” animal or human diagnostic or therapeutic applications as the products supplied are neither IVDs nor medicinal products. Customers using the products e.g. in a formulation, cell culture procedure, kit ingredient, blocking agent, or stabilizing reagent that results in the customer’s final product becoming an IVD or a component part of an IVD kit are covered by the “For Further Manufacturing” portion of the intended use statement.
Alternatively, if the products are used to grow cells or other medium in order to produce a medicinal component (e.g., monoclonal antibody, vaccine, etc.), then this too will fall under the “For Further Manufacturing Use” statement in the intended use.
GE Healthcare has concluded that GMP-certified claims are not appropriate and will no longer be made for cell culture media products. The manufacture and quality control of cell culture media and reagents manufactured by GE Healthcare are now being overseen by a team of GE employees, who are implementing a GE Quality Management System (QMS) based on the same QMS employed at our other ISO 9001:2008 certified sites. It is expected that the Pasching site will be ISO 9001:2008 certified within the coming months.
Liquid products are currently processed in a production area where serum from different sources is processed. We confirm all of the respective products are sourced in countries of category A or B according to OIE classification, as described in the Annex to Commission Decision 2007/453/EC.
A cleaning process using appropriate detergents and further heat inactivation is in place and is performed between every production batch.
Liquid products are sterile-filtered when specified in the product specification, and sterility testing is performed according to current EP or USP, as applicable.
Due to the requirements of biopharmaceutical customers GE Healthcare is no longer providing products with antibiotic content.
GE Healthcare provides customers with the following statement regarding animal origin free products:
"It is hereby stated that the product listed above is not derived from material of animal origin. No animal derived material is used in the raw materials or manufacturing process of the product. A Certificate of suitability is not relevant for this product."