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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

  • 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.
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  • VITEK® MS PRIME MALDI-TOF Mass Spectrometry System

    Superior Workflow. Prime Results.

    The VITEK® MS PRIME is an innovative MALDI-TOF mass spectrometry system that takes your automated identification experience to the next level.
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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.

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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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