The investment… includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP [manufacturers]”
Nelson Labs, a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries has announced its Itasca, Illinois laboratory in the US 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 30,000ft2 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.
New laboratory features at the Pharmaceutical Center of Excellence
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 Nelson Labs Itasca facility is current good manufacturing practice (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 in this US, and Leuven, Belgium.
“The development of a Pharmaceutical Center of Excellence at our Itasca laboratory reflects our commitment to providing comprehensive CMC support services for POPD,” Aryo Nikopour, the company‘s Vice President, Global Segment Leader, Pharma shared. “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.”
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