Skip to main content

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

Learn More

  

Product List

  • ENDONEXT™

    Better for your lab. Better for the planet.

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

  • ENDOXPERTS™

    Low Endotoxin Recovery

    The phenomenon of Low Endotoxin Recovery (LER) has gained renewed attention in the scientific community in recent years as the FDA now requires that all new Biological License Applications are able to successfully unmask when LER occurs. ENDOXPERTS™ is our solution for unmasking LER, which helps you meet regulatory requirements.
    View Product

  • 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.
    View Product

  • 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.
    View Product

  • 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.
    View Product

  • 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.
    View Product

  • 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.
    View Product

  • 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.
    View Product

  • VITEK® 2 COMPACT

    Your Solution for Automated Microbial Identification

    The VITEK® 2 Compact system offers quality control testing solutions for fast and accurate microbial identification. With technology that includes an extensive and robust identification database, rapid results, and minimal training time, it will streamline laboratory workflow for increased productivity.
    View Product

  • VITEK® MS Rapid Identification of Microorganisms

    Improve Your Productivity and Increase Confidence

    VITEK® MS was developed for its rapid identification of microorganisms for the pharmaceutical,personal care, and food industries. Suitable for industrial manufacturers and pharmaceutical laboratories who work with microbial identification, our knowledge base contains the most frequently encountered organisms in pharmaceutical, food and animal health applications.
    View Product

Resources

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.

Learn More

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.

Learn More

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.

Learn More