Eurofins MWG Operon Announces Addition of GMP Services for IVD and ASR Manufacturing

Custom cGMP and cGLP services enable highly standardized process controls to meet customer requirements.

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The Eurofins MWG Operon site in Huntsville, AL houses a fully enclosed manufacturing facility.

This historic facade houses Eurofins MWG Operon state-of-the-art manufacturing facilty

With the establishment of a single department devoted to cGMP and other regulatory needs, customers have streamlined access to customized products with highly standardized process controls, documentation, and a map of expected milestones.

Huntsville, AL (PRWEB) October 10, 2013

Eurofins MWG Operon has opened a new department to meet the growing demand for cGMP and GLP manufacturing for IVD (in vitro diagnostic) and ASR (analyte-specific reagent) applications within the clinical, pharmaceutical, food safety, and animal health industries. In order to meet regulatory requirements, clients increasingly request highly standardized process controls be applied to the earliest phases of their research and development and through the commercialization of their products and services. Eurofins MWG Operon seeks to meet this demand by offering a full pipeline of customized cGMP services, handled through a single point of contact, to support full commercialization. In addition, Eurofins MWG Operon supports cGMP ASR manufacturing and testing on intended-use genomic platforms.

As a global leader for a wide range of genomics products and services, Eurofins MWG Operon implemented the cGMP department in order to support its customers’ full scope of needs from pilot projects through manufacturing of small to large-scale cGMP oligonucleotides which require regulatory documentation. Eurofins is only able to offer cGMP services due to several internationally recognized certifications on quality and process control, including ISO 9001:2008, ISO 13485: 2003 and FDA registration.

CEO, Martin Kunz stated, “We’ve been seeing a large increase in requests for cGMP services. With the establishment of a single department devoted to cGMP and other regulatory needs, customers have streamlined access to customized products with highly standardized process controls, documentation, and a map of expected milestones."

Further information on cGMP oligos can be found at http://www.operon.com/products/cGMP/mainpage.aspx

About Eurofins MWG Operon

Eurofins MWG Operon, a member of the Eurofins Group with major offices and production facilities in the United States, Europe, and Asia, is an international provider of DNA sequencing services, DNA synthesis products, and bioinformatics services for academic and industrial research. The company’s strengths are its strong customer orientation, fast service, and high quality. For additional information, please visit our website at: operon.com.


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