As the demand for new and innovative medicines grows, so does the endotoxin testing sector. Endotoxins are pyrogens and a key component of the outer membrane of gram-negative bacteria. If administered parenterally, products contaminated with endotoxins may elicit such a severe immune response that it can be fatal. As endotoxins are ubiquitously present in the environment, injectable pharmaceuticals and medical devices, as well as the raw materials they are produced from, must be tested for endotoxin contamination to ensure patient safety.
Cotton Mouton Diagnostics Ltd (CMD) based in Cardiff, UK, has established a state-of-the-art contract endotoxin testing facility, which holds both ISO 9001 and ISO/IEC 17025 accreditation. In addition to offering routine endotoxin testing, CMD is also able to carry out low endotoxin recovery studies, as well as assay development and validation work for customers.
The Centre is a collaboration with the LAL division of FUJIFILM Wako Chemicals U.S.A. Corporation. FUJIFILM Wako manufactures the PYROSTAR™ ES-F line of endotoxin testing reagents, which provide best in-class sensitivity while ensuring no cross reactivity with other microbial contaminants.
Jenna Bowen, CEO of Cotton Mouton Diagnostics, says “We’re thrilled to have secured ISO 17025 and ISO 9001 accreditation for our endotoxin testing service. The CMD team have worked diligently over the last 12 months to ensure that the service we offer is of the highest quality and to have this formally recognized via these accreditations is fantastic. Collaboration with the FUJIFILM Wako LAL team ensures a consistent supply of first-class testing reagents, providing reassurance to our customers that CMD will continually provide a high level of service."
Lisa Komski, Sales General Manager for FUJIFILM Wako’s LAL Division, says “Our entire team is extremely excited to be part of this new venture with CMD and we are honored to be able to provide our PYROSTAR™ line of LAL products in support of their innovative testing facility. With the combination of CMD’s exceptional technical expertise and FUJFILM Wako’s top quality endotoxin detection reagents, we are certain the Centre will provide a valuable and highly anticipated portfolio of testing services that our customers can truly rely on.”