Millipore Awarded CE Mark

By Biotechdaily staff writers
Posted on 27 Feb 2004
The European Union's Council of Ministers has granted the CE Mark to the clinical sample preparation devices manufactured by Millipore (Billerica, MA, USA). These include the following product families: Amicon, Centriprep, Centricon, and Centrifree centrifugal filter units; and Minicon and Miniplus static concentrators.

These products are used to concentrate and purify macromolecules in human specimens (serum, urine, spinal fluid, and other biologic fluids) prior to final analysis. Under European regulation, all clinical diagnostic devices must bear the CE marking. Millipore is a bioscience company that provides technologies, tools, and services for the discovery, development, and production of new therapeutic drugs.

In an unrelated development, Millipore recently announced the formation of a bioprocessing alliance with HyClone Laboratories (Logan, UT, USA; www.hyclone.com). The collaboration will combine the critical elements required for value-added disposable manufacturing solutions. Biopharmaceutical manufacturers will have only one supplier contact now for the design, development, and validation of disposable manufacturing systems that combine HyClone bioprocess containers with various Millipore disposable separations products.

"Both Millipore and HyClone have worked with pioneering biopharmaceutical companies to validate single-use disposable systems. Our collaborative efforts indicate that these companies are committing significant resources to the validation and implementation of disposable strategies,” said Susan Vogt, president of Millipore's BioPharmaceutical division.




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