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RAPID RESULTS YOU CAN TRUST

Cell & Gene Therapy Testing

Cutting-edge cellular therapy products demand state-of-the-art quality control. Your business requires rapid, accurate results you can trust to ensure product safety and protect consumer health.

Comprehensive Quality Testing Solutions

With a comprehensive portfolio of rapid microbiology testing solutions, we can help streamline your laboratory workflows, boost efficiency, and prevent compliance issues. See how you can optimize the manufacturing of your cell and gene therapies, and ensure patient safety with our comprehensive range of systems and smart quality testing solutions.

Adopt Reliable, 1-Hour In-House Mycoplasma Testing to Maximize Efficiency While Saving Costs

1-Hour Mycoplasma Testing By Anyone, Anywhere, Anytime

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Product List

  • BIOFIRE® Mycoplasma

    Rapid Testing by Anyone, Anywhere, Anytime

    BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
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  • ENDONEXT™

    The Evolution of Endotoxin Testing

    ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.

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  • ENDONEXT™ Automated with Tecan

    We have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform. 

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  • ENDOXPERTS™ Services

    Comprehensive Endotoxin Services with a Special Focus on Low Endotoxin Recovery (LER)

    ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER. Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. 

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  • ENDOZYME® II GO STRIPS

    Flexible Endotoxin Testing

    Laboratories don’t always need to test all 20 samples to fill a full plate—that’s why ENDOZYME® II GO STRIPS are designed with flexibility in mind: the flexibility to use only what you need, when you need it.

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  • Feasibility Study

    Quickly Confirm Your Product Compatibility and Method

    A feasibility study is probably the single most important consideration when it comes to changing your method of application. Saving you time, resources, and energy, it’s a vital aspect of ensuring compatibility.
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  • Instrument Service Plans and Support

    Maximize the Uptime of your Instruments. Ensure Continuous Operations.

    Regular maintenance means more reliable and stable systems that reduce downtime, increase efficiency, and improve the performance of your equipment. Our goal is to provide the service you need, when you need it. In order to achieve this, we’ve developed a range of service packages tailored to laboratories of all sizes.
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  • SCANRDI®

    Rapid Microbial Detection and Enumeration

    SCANRDI® revolutionized rapid microbial detection when it was first introduced and still today its speed and sensitivity remain unrivaled.
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  • VILINK® Instrument Management System        

    Instrument Management System

    VILINK® software is our real-time support system that keeps the instruments in your laboratory running via remote monitoring.

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  • VITEK EXPRESS Identification Services

    ID Services Powered by Microbiology Experts

    As microbiologists, we know fast and reliable results are of the utmost importance. Get the accurate identifications you need quickly and easily.
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Resources

Selkirk Pharma Implements 3P® ENTERPRISE To Streamline Environmental Monitoring Processes

Selkirk Pharma is a U.S. based contract manufacturing organization specializing in the sterile fill and finish of injectable drugs, including vaccines and biological therapies. Their state-of-the-art facility in Spokane, Washington boasts cutting-edge technology and recently completed the implementation of 3P® ENTERPRISE. 

DOWNLOAD TESTIMONIAL

ON-DEMAND: BACT/ALERT® 3D: FROM ALTERNATIVE TO ROUTINE FOR TESTING CELL AND GENE THERAPY PRODUCTS

Listen to Lori Daane, Sr. Director of Scientific Affairs at bioMérieux, discuss rapid sterility testing within the cell and gene therapy landscape. She discusses the evolving regulations and why the BACT/ALERT® has continued to be the go-to instrument of choice for testing these products for microbial contamination.

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CUTIBACTERIUM ACNES GRAM POSITIVE BACTERIA CAUSING INFECTION

Cutibacterium acnes (C. acnes) is a Gram positive bacteria that prefers anaerobic (without air) growth conditions1. Cutibacterium acnes can be found on the skin of virtually every human, and it is one of the bacteria that can cause acne. Acne is one of the most common skin diseases, affecting more than 45 million individuals in the United States.

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RAPID STERILITY TESTING OF GENE AND CELL THERAPY PRODUCTS

Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients, and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.

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