Nelson Labs Itasca facility expands capabilities to offer state-of-the-art CMC analytical testing support
Salt Lake City, UT, February 13, 2023 – Nelson Labs, a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, announces its Itasca, Illinois laboratory as a new Pharmaceutical Center of Excellence to serve the unique needs of parenteral and ophthalmic drug product (PODP) manufacturers. The investment expands the site to over 30,000 square feet and includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP product customers who require the highest levels of safety, sterility, and stability.
The laboratory is now equipped with a new SKAN isolator suite, enabling Nelson Labs to perform testing for sterility assurance with the highest level of sterility control. The new isolator suite will complement the existing sterility assurance capabilities at the lab. Additionally, various technologies and expertise have been added to support drug substances, drug products, raw materials, and primary container closure release and stability studies. These technologies are chromatographic, including HPLC, UPLC, IC, and LC-MSD; spectroscopic, including UV-Vis, FTIR, and AA; spectrometric, including ICP-MS; in addition to other technologies used for physical and chemical determination.
“The development of a Pharmaceutical Center of Excellence at our Itasca laboratory reflects our commitment to providing comprehensive CMC support services for POPD,” said Aryo Nikopour, Vice President, Global Segment Leader, Pharma. “Nelson Labs has been a global leader in laboratory testing for over 35 years, known for its scientific excellence and commitment to quality. We are excited to enter this next stage of world-class testing for pharmaceutical and biopharmaceutical products.”
The Nelson Labs Itasca facility is cGMP compliant and is a fully accredited pharmaceutical testing laboratory that complements global pharmaceutical services provided by Nelson Labs sites in Salt Lake City, Utah, and Leuven, Belgium.
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About Nelson Labs
Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We serve over 3,000 customers across 13 facilities in the United States, Mexico, Asia and Europe. With a comprehensive array of over 900 laboratory tests and the expertise of Regulatory Compliance Associates, a recognized leader in life science consulting, we support our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
Safeguarding Global Health® – with every test completed. Learn more: nelsonlabs.com.
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Media Contact
Nelson Labs
Kate Corr, Senior Marketing Manager, Americas
801-290-9190
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