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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

  • 3P® CONNECT SOFTWARE

    Em-body Connectivity

    3P® CONNECT is designed to secure sample traceability and collection of your Environmental Monitoring (EM) data to ensure reliable decision-making and optimize process efficiency. This comprehensive system includes dedicated software and  performant pre-barcoded 3P® SMART PLATES. Skipping the traditional paper-based process for EM decreases risk of errors and saves time during the entire production process.

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  • 3P® ENTERPRISE

    Em-power the Future

    Bridging the gap between standard processes and automation, 3P® ENTERPRISE transforms the future of environmental monitoring in the pharmaceutical industry. From sampling to trending, take control with an end-to-end, fully digitalized and automated workflow. Increase efficiency and ensure your products are safe and compliant with an innovative environmental monitoring system.

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  • 3P® Environmental Monitoring Culture Media

    Bringing Confidence to Your Environmental Monitoring

    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

    Em-brace Traceability

    When conducting routine microbial surveillance of pharmaceutical manufacturing facilities, accuracy can empower you to make smarter decisions, meaning products, employees, and patients remain safe, and your business operates in compliance with regulatory guidelines. When it comes to Environmental Monitoring (EM), state-of-the-art culture media is a necessity when you’re counting on traceability and definitive results.

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  • 3P® Support & Services

    Your Vision, Our Mission

    As your partner, we’re committed to providing you with the assistance and services you need to make implementation easier and faster.

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  • AIR IDEAL® 3P®

    Bring Confidence to your Environmental Monitoring

    AIR IDEAL® 3P® is used for the detection of viable organisms through active air sampling.
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  • BACT/ALERT® 3D

    The Method Of Choice For Rapid Sterility Testing

    BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing. From its ease of use to its flexibility, BACT/ALERT® 3D is a state-of-the art microbial detection system suitable for any size laboratory, providing you with a reliable and objective alternative to traditional microbial detection methods.

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  • BACT/ALERT® Culture Media Bottles

    Innovative and Optimized Culture Media

    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

    Microbiological Quality Control

    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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  • BIOBALL® Custom Services

    BIOBALL® Custom Services helps you simplify the implementation of microbial strains of your interest in the routine microbiological quality control.

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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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