Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in method development, bacterial endotoxin testing (BET), and glucan contamination. With the most extensive experience of any endotoxin testing laboratory in the world, CTS is GMP compliant, ISO registered, and licensed by the US Drug Enforcement Agency (DEA) as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with US Food and Drug Administration (FDA), United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or Japanese Pharmacopoeia (JP), depending on your specifications.
In addition to routine testing, CTS has extensive expertise and the ability to customize endotoxin testing to individual client needs, develop methods for difficult samples and devices, transfer BET test methods, and design and produce custom depyrogenation controls for oven validations.
CTS has experience with the following sample types: