The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.
Nelson Labs announced on Feb. 14, 2024 that its facility in Itasca, Ill., is being established as a Pharmaceutical Center of Excellence for parenteral and ophthalmic drug product manufacturers. The facility will feature more than 30,000 square feet of space and include instrumentation for full chemistry, manufacturing, and controls (CMC) support.
The laboratory is compliant with current good manufacturing practices and includes a SKAN isolator suite for performing testing for sterility assurance. The suite will add to the lab’s existing sterility assurance capabilities. The lab will also provide support for drug substances, drug products, raw materials, and primary container closure release and stability studies, including high-performance liquid chromatography (HPLC), ultra-high performance liquid chromatography, ion chromatography, LC-mass spectrometry detector (MSD); spectroscopic, including UV-Vis, Fourier transform infrared spectroscopy, and atomic absorption; spectrometric, including Inductively coupled plasma mass spectrometry.
“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, in a press release. “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.”
Nelson Labs provides microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. The company as more than 3000 customers and facilities in the United States, Mexico, Asia, and Europe. Services include more than 900 laboratory tests and regulatory consulting.
Source: Nelson Labs
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