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bioMérieux Announces Availability of Method Validation Services for BIOFIRE® Mycoplasma

Collaboration With Bionique Testing Laboratories Allows for Faster and Easier Implementation

CHICAGO – September 16, 2024 – bioMérieux is delighted to announce the availability of method validation services for the BIOFIRE® Mycoplasma test through a new collaboration with Bionique Testing Laboratories, a leading provider of mycoplasma testing services for the life science industry. This collaboration aims to provide our valued customers with comprehensive product-specific validation services, helping ensure the highest standards of quality and supporting their CMC regulatory compliance while easing the implementation of the BIOFIRE® FILMARRAY® 2.0 Industry system.

The new BIOFIRE® Mycoplasma method validation service will allow customers to:

  • Expedite mycoplasma method validation on the BIOFIRE® FILMARRAY® 2.0 Industry system.
  • Save valuable lab resources by externalizing validation projects.
  • Avoid in-lab contamination risk during validation studies.
  • Leverage industry-recognized expertise.
  • Help ensure CGMP compliance.

This service not only streamlines the customer’s validation journey, but also establishes confidence in testing protocols, essential for meeting the scrutiny of regulatory authorities.

With two levels of standardized service available to address the unique needs of our biologics customers, we can quickly demonstrate suitability for products in early clinical trials through commercialization. Tailored validation packages are also available and are designed to meet the specific testing needs and CMC requirements of individual products. With validation timelines as short as six months from the receipt of material (clinical trial stages), we are committed to accelerating time to routine testing while supporting regulatory compliance and product quality.

Leveraging our new BIOFIRE® validation service provides access to Bionique’s mycoplasma testing expertise, empowering our customers to navigate the complexities of validation with ease. This allows them to focus on advancing research and delivering innovative solutions to patients.

For more information on BIOFIRE® Mycoplasma, please visit: https://www.biomerieux.com/us/en/our-offer/industry-products/biofire-mycoplasma-mycoplasma-detection.html.

    

ABOUT BIOMÉRIEUX

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics since 1963, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors. In 2022, revenues reached €3.6 billion, with over 90% of sales outside of France.

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. www.biomerieux.com

    

ABOUT BIONIQUE TESTING LABORATORIES

Bionique Testing Laboratories is a global leading Contract Research Organization providing mycoplasma testing services for the biopharmaceutical and life science industries for more than 30 years. Located in Saranac Lake, NY, Bionique operates two FDA-registered, CGMP facilities. Bionique’s mission is to provide reliable and accurate results that support customers’ quality control needs and ensure the safety and purity of pharmaceutical drugs, cell and gene therapies, and vaccines. Bionique is an integral part of the Biosafety Testing Services Unit of Asahi Kasei Bioprocess. Bionique’s commitment to excellence aligns perfectly with bioMérieux's dedication to advancing diagnostic solutions. Further information about Bionique can be found at www.bionique.com.