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Rely On A Proven, Rapid Sterility Testing Solution With BACT/ALERT® 3D

Today, BACT/ALERT® 3D stands as the trusted choice for Cell & Gene therapy manufacturers, particularly for those working with approved CAR-T cell therapies. Our advanced solution is designed to meet the unique challenges of this dynamic industry in which precision and efficiency in sterility testing are paramount. Empower your manufacturing with rapid, reliable, and real-time sterility testing that enables quality and compliance.

BACT/ALERT® 3D Offers Cell & Gene Therapy Manufacturers:

Streamlined Workflow
Integrate testing closer to the production line with on-demand capabilities and automated reading, eliminating the need for specialized technical skills or dedicated lab setups.

Rapid Turnaround
Accelerate your testing processes without sacrificing accuracy. BACT/ALERT® 3D ensures that you receive timely results, allowing for quicker adjustments and enhanced production efficiency.

Enhanced Decision-Making
With real-time monitoring, you gain immediate insights into your sterility testing, supporting proactive management and decision-making throughout your manufacturing process.

   

Why BACT/ALERT® 3D for Cell & Gene Therapies?

  • Regulatory Acceptance
    BACT/ALERT® 3D complies with industry standards, allowing reliable quality assurance and regulatory compliance. It is recognized as a compendial method in the following chapters:
    • EU. Ph. Chapter 2.6.27 - Microbiological Examination of Cell-based Preparations
    • ChP <9406 > Guidelines for Microbiological Test of Cellular Therapy Products
    • USP <72> Respiration-Based Rapid Microbial Methods for the Release of Short Shelf-Life Products (pending its publication)
  • Efficient & Reliable
    Trusted by Leading Cell and Gene Therapy Manufacturers, Its Streamlined, 3-Step Process Ensures Fast, Accurate Results With Minimal Hands-On Time. 
  • Real-Time Monitoring
    Receive instant insights into microbial contamination with real-time monitoring, enabling swift, informed decision-making to uphold sterility standards.
  • Versatile Compatibility
    Designed to handle a broad spectrum of matrices, including the most complex ones, BACT/ALERT® 3D supports both in-process and release testing, making it essential for all stages of production. 

BACT/ALERT 3D

Discover Automated Rapid Sterility Testing with BACT/ALERT® 3D for Cell & Gene Therapies

Contact our experts today for more information on BACT/ALERT® 3D.

Learn More About BACT/ALERT® 3D

ON-DEMAND WEBINAR

BACT/ALERT® 3D: From Alternative to Routine for Testing Cell and Gene Therapy Products

This on-demand webinar explores rapid sterility testing in Cell and Gene therapy, covering the pivotal role of rapid testing and evolving regulations. Discover why the BACT/ALERT® is the trusted choice for microbial contamination testing and optimize your processes for enhanced quality control and compliance!

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PRODUCT PAGE

BACT/ALERT® 3D

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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WHITE PAPER

A Recognized Rapid Microbiological Method for Cell & Gene Therapy Products: Regulation & Industrial Application

This white paper details how innovative microbiological technologies are revolutionizing sterility testing for Cell and Gene therapy products. You'll learn the validation guidelines for alternative microbiological methods and gain understanding of the regulatory evolution and acceptance of rapid microbial testing.

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Close-up image of cell for Advanced Therapy and Cell & Gene Therapy CGT.

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There’s no time to lose when a patient relies on your product. Streamlined quality control testing specific to cell and gene therapies yields safe, rapid and efficient results.

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