Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for 50 years. ACC pioneered LAL testing methodology and was the first FDA-licensed company to manufacture LAL reagents, and throughout the years, has grown to be an internationally recognized leader in endotoxin detection.
In 2021, we were very excited to introduce another first when we launched the first commercially available sustainable BET Recombinant Cascade Reagent (rCR), PyroSmart NextGen®. PyroSmart NextGen is completely horseshoe crab blood-free and, unlike first-generation recombinant BET reagents (rFC), PyroSmart NextGen uses the same LAL cascade as traditional LAL reagents, while eliminating the potential for (1→3)-β-D-glucans. This eliminates the need to change test methods and purchase new specialized instrumentation as required by first-generation FC recombinant reagents. Simply put… same Instrument, same preparation steps, same method. Furthermore, with the proposed new standard, a Chapter from the USP Expert Committee to include rCR recombinant reagents, there’s never been a better time to consider transitioning to PyroSmart NextGen®. Keep your Method… Make an Impact!
Our worldwide headquarters are located in Falmouth, Massachusetts. 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. Our reagents are FDA licensed and can be used for testing in compliance with USP, EP, and JP bacterial endotoxin test chapters, and our software is 21 CFR Part 11 Compliant.
ACC also operates a Contract Test Services (CTS) Laboratory, which has specialized in testing for endotoxin and glucan 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, nd perform Low Endotoxin Recovery (LER) studies/protocols.
ACC also offers a clinical diagnostic product line–Fungitell® and operates a CCLIA-certified laboratory specializing in (1→3)-ß D-glucans analysis to support the diagnosis of Invasive Fungal Disease (IFD).