Associates of Cape Cod, Inc. Information

Specializing in recombinant and traditional chromogenic and turbidimetric reagent technologies for 50 years. Today, we are recognized as an international leader in endotoxin and (1→3)-ß-D-glucans detection. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents. Our latest offering, PyroSmart NextGen®, is a recombinant technology that replicates the LAL enzyme cascade without animal content. Our global headquarters are located in East Falmouth, Massachusetts, USA. In Europe, our office in Knowsley, UK, established 30 years ago, is supported by our distribution warehouse in Nijverdal, NL. With a dedication to quality, ACC is certified to I.S. EN ISO 13485:2016 and ISO 13485:2016. We are FDA inspected and operate DEA Licensed and CLIA-certified laboratories. Our endotoxin detection reagents, instruments and software are used within the Pharmaceutical, Medical-Device, Biotechnology, Compounding Pharmacy and Dialysis industries for quality control, product release and research. ACC operates a Contract Test Services (CTS) Laboratory which has specialized in testing for endotoxin contamination for over 40 years. Our CTS laboratory is GMP compliant, ISO registered and DEA licensed and is capable of handling all controlled drug substances except those included in Schedule 1. All testing services can be performed to FDA, USP, EP and/or JP regulatory guidelines. In addition to routine testing, our CTS Laboratory will customize endotoxin testing, troubleshoot difficult samples, develop and/or transfer LAL test methods, design and produce custom depyrogenation controls for oven validation and perform Low Endotoxin Recovery (LER) studies/protocols. ACC also offers a clinical diagnostics product line and operates a CLIA-certified laboratory specializing in (1→3)-ß-D-glucan analysis to support the early diagnosis of invasive fungal infection (IFI). Learn more: https://www.linkedin.com/in/fungitell-assay-3269a2154/