Associates of Cape Cod

About Associates of Cape Cod

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 45 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.

Our worldwide headquarters are located in East Falmouth, MA. 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 BET 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 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 diagnostics product line and operates a CLIA-certified laboratory specializing in (1→3)-ß-D-glucan analysis to support the diagnosis of Invasive Fungal Disease (IFD). For more information please visit https://www.linkedin.com/in/fungitell-assay-3269a2154/

Website	http://www.acciusa.com
Employees	201-500 employees View all Associates of Cape Cod employees
Industry	Biotechnology
Headquarter	124 Bernard E. Saint Jean Drive, East Falmouth, MA 02536, US
Founded	1974
Keywords	Beacon Diagnostics® Laboratory, Contract Test Services (Cts), Endotoxin/Glucan Detection (Lal), Fungitell®

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Frequently Asked Questions about Associates of Cape Cod

Who is the CEO of Associates of Cape Cod, Inc.?

Aj Meuse is the CEO of Associates of Cape Cod, Inc.. To contact Aj Meuse email at [email protected].

Who are the decision makers in Associates of Cape Cod?

The decision makers in Associates of Cape Cod are Alison Skinner, Anna Owens, Carlos A Castro, etc. Click to Find Associates of Cape Cod decision makers emails.

What types of services does Associates of Cape Cod offer?

Associates of Cape Cod, Inc. (ACC) offers a range of services focused on endotoxin and (1→3)-ß-D-glucans detection. These include contract test services (CTS) for pharmaceutical and biotechnology companies, as well as specialized testing through their Beacon Diagnostics® Laboratory. Their expertise lies in chromogenic and turbidimetric reagent technologies, ensuring accurate and reliable results for endotoxin testing.

What is the Beacon Diagnostics® Laboratory and what services does it provide?

The Beacon Diagnostics® Laboratory is a specialized facility operated by Associates of Cape Cod that provides comprehensive testing services for endotoxins and (1→3)-ß-D-glucans. The laboratory utilizes advanced methodologies and technologies to deliver precise and timely results, helping clients in the pharmaceutical and biotechnology industries ensure product safety and compliance with regulatory standards.

How does the endotoxin detection process work?

Endotoxin detection at Associates of Cape Cod typically involves the Limulus Amebocyte Lysate (LAL) test, which is a widely accepted method for detecting endotoxins in various samples. The process includes preparing the sample, adding LAL reagent, and measuring the resulting reaction, which can be quantified using chromogenic or turbidimetric methods. This ensures that any endotoxin present is detected accurately, allowing for necessary quality control measures.

What industries does ACC support with its testing services?

Associates of Cape Cod supports a variety of industries, primarily focusing on the pharmaceutical, biotechnology, and medical device sectors. Their testing services are crucial for companies involved in drug development, manufacturing, and quality assurance, helping them meet stringent regulatory requirements and ensuring the safety of their products.

What is Fungitell® and how is it used?

Fungitell® is a diagnostic test developed by Associates of Cape Cod for the detection of (1→3)-ß-D-glucans, which are indicative of fungal infections. This test is particularly useful in clinical settings for monitoring patients at risk of invasive fungal infections, such as those undergoing chemotherapy or with compromised immune systems. The Fungitell® assay provides timely and accurate results, aiding in the diagnosis and management of fungal diseases.

Can ACC provide customized testing solutions for specific client needs?

Yes, Associates of Cape Cod is committed to offering customized testing solutions tailored to the specific needs of their clients. Through their Contract Test Services (CTS), ACC collaborates closely with clients to develop and implement testing protocols that meet unique requirements, whether for product development, regulatory compliance, or quality assurance. Their experienced team is dedicated to providing flexible and responsive service to ensure client satisfaction.