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BIOBALL®

Precision Microbial Testing For Cell & Gene Therapies

Elevate your testing processes with BIOBALL® and ensure the reliability of your products. These small, water-soluble balls contain a precise number of microorganisms, delivering consistent accuracy and precision in every batch.

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Achieve Unmatched Accuracy In Your Microbial Testing With BIOBALL®

Overcoming complex manufacturing challenges and ensuring the quality, safety, and efficacy of cell and gene therapies is critical. BIOBALL® Standardized Strains are designed to meet the exacting standards of the cell & gene therapy market, providing consistent results you can trust. BIOBALL® is ideal for a wide range of applications, including growth promotion testing, method validation, and antimicrobial efficacy testing. It is also effective for in-process control, raw material testing, media fill tests, release testing, and cell bank testing.

BIOBALL® Offers Cell & Gene Therapy Manufacturers:

Consistent Accuracy

A precise and standardized number of microorganisms in each ball, ensuring accurate and reliable results for microbial testing. 

Batch-to-Batch Reliability

The standardized formulation of BIOBALL® ensures uniform performance across different batches, reducing variability and enhancing reproducibility in your testing processes.

Simplified Workflow

Its easy-to-use, water-soluble format streamlines testing procedures, minimizes handling errors, and improves efficiency in the laboratory, allowing manufacturers to focus on critical aspects of their production.

   

Why BIOBALL® For Cell & Gene Therapies?

  • Standardized Microorganism Counts
    Delivers a precise, known quantity of microorganisms in each ball, ensuring consistent accuracy across all tests. 
  • Uniform Formulation
    Consistent formulation minimizes variability and provides reproducible results, which is essential for maintaining rigorous quality control and regulatory compliance.
  • User-Friendly Design
    Its ease of use reduces handling errors and speeds up the testing process, allowing your lab to operate more efficiently and focus on critical aspects of production.
  • Robust Control Standards
    Robust control is vital for ensuring the safety and efficacy of cell and gene therapy products, helping you meet industry-specific quality and regulatory requirements.
  • Controlled Microbial Load
    The controlled and accurate microbial load helps maintain the integrity of your tests and the safety of your products.
  • Efficient Resource Management
    Reliable performance reduces the need for repeated tests and rework, which can translate into cost savings over time. 

Discover Microbial Testing With BIOBALL® For Cell & Gene Therapies

Complete the form below to get in touch with our team. A bioMérieux expert will be in touch using the contact information you provide. By providing your information, you agree to receive additional emails from bioMérieux about microbiological quality control.

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Learn More About BIOBALL®

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Article

Why Pharmaceutical Developers Use BIOBALL®

The intellectual properties and proprietary methodologies used in making BIOBALL® redefine what was considered as quantitative microbiology and make it simple to get precise and accurate quantitative microbiological quality controls batch after batch.
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Webinar

BIOBALL® 3-Part Webinar Series

In this three-part webinar series, you’ll learn about BIOBALL® from industry experts Dr. Megha Bajaj and Dr. Tony Cundell. Discover BIOBALL® best practices, applications in non-sterile product testing methods, our in-house Isolate service, and more.
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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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Cell & Gene Therapy Solutions

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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