APR Sept/Oct 2023 - 14

Associates of Cape Cod, Inc.
124 Bernard E. Saint Jean Drive
Falmouth, MA 02536
Tel: 888-395-2221
Email: custservice@acciusa.com
www.acciusa.com
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 nearly 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)-ß-D-glucans.
This eliminates the need to change test methods and purchase
new specialized instrumentation as required by first generation
rFC recombinant reagents. Simply put... same Instrument, same
preparation steps, same method. Furthermore, with the proposed
new standard, Chapter <86> 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
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| September/October 2023
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 and
perform Low Endotoxin Recovery (LER) studies/protocols.
ACC also offers a clinical diagnostic product line - Fungitell®
and operates a CLIA-certified laboratory specializing in (1→3)-ß-Dglucans
analysis to support the diagnosis of Invasive Fungal
Disease (IFD).
http://www.acciusa.com
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
