Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc (ACC) has been a leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 40 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents; ACC has grown to be an internationally recognized leader in endotoxin detection.
With a dedication to quality, ACC is certified to I.S. EN ISO 13485:2012 and ISO 13485:2003. 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 30 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 diagnostic product line and operates a CLIA-certified laboratory specializing in (1→3)-ß-D-glucans analysis to support the diagnosis of Invasive Fungal Disease (IFD).
Visit our website: www.acciusa.com
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing
April 2nd 2025Sitting down with the PharmTech Group at INTERPHEX 2025, Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, discusses the design and critical role of walk-in chambers in the bio/pharmaceutical industry.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.