NEW YORK (GenomeWeb) – Sigma-Aldrich today said that two of its St. Louis facilities have received ISO 13485 certification for expanded quality assurance capabilities.
The certification extends the firm's ability to manufacture and offer raw materials including proteins, enzymes, and antibodies used in diagnostic assays, Sigma-Aldrich said. With the certification, its in vitro diagnostic customers can also be assured that their supply chain needs will be met, the firm said.
Sigma-Aldrich's Dekalb site manufactures proteins and enzymes and received ISO 13485 certification after an investment into its production and packaging capabilities, as well as personnel training. Meanwhile, its facility in Barton can now serve as a central North American distribution center for the company's raw materials designed for IVD manufacturing applications.
Sigma-Aldrich is in the process of being acquired by Merck KGaA for $17 billion. The firms have said that they aim to close the deal by mid-2015.