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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.

Product List

  • 3P® CONNECT

    Monitoring quality in microbiology is critical and challenging for pharmaceutical companies. ​While hand transcription remains the standard procedure in use, these daily processes often rhyme with errors leading to time-consuming investigations, and not fully compliant data.​

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  • 3P® ENTERPRISE

    Environmental monitoring (EM) is the main microbiological control performed by pharmaceutical industries. While multiple hand-written and transcription operations remain the standard procedure in use for thousands of samples per month, the daily processes often result in errors leading to time-consuming investigations, low value-added tasks and data that is not fully compliant. As a result: major impacts on batch release, on process efficiency and ultimately patient safety.

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  • 3P® Environmental Monitoring Culture Media

    Accurate and reliable environmental monitoring solutions will bring you confidence when making product release decisions, allowing you to protect your product and your patients.

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  • 3P® SMART PLATES

    The 3P® legacy is one of delivering proven performance when it comes to effective pharmaceutical contamination control. Now it’s going digital.

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  • AIR IDEAL® 3P®

    AIR IDEAL® 3P® is used for the detection of viable organisms through active air sampling.

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  • BACT/ALERT® 3D

    The BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing.

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  • BACT/ALERT® Culture Media Bottles

    The BACT/ALERT® Culture Media Bottles, used in conjunction with the BACT/ALERT® 3D or BACT/ALERT® VIRTUO®, offer advantages across every dimension of microbial testing.

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  • BIOBALL® Standardized Strains

    BIOBALL® is a small water-soluble ball containing a precise number of microorganisms that delivers accuracy and precision, batch after batch.

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  • BIOFIRE® Mycoplasma

    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™

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

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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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