Minaris Boosts Mycoplasma Detection Efficiency with New BIOFIRE® Technology

Minaris Amplifies Rapid Mycoplasma Detection Services

In a noteworthy move to expedite the testing processes for cell and gene therapies, Minaris Advanced Testing has recently expanded its mycoplasma detection services utilizing bioMérieux's innovative BIOFIRE® platform. This step aims to significantly shorten the turnaround times for mycoplasma testing, an essential component in ensuring the safety and efficacy of advanced therapeutic products.

Expanding Mycoplasma Testing Capabilities

Minaris, a global leader in cell and gene therapy contract development and manufacturing (CDMO), is leveraging the advanced capabilities of the BIOFIRE® Mycoplasma system to enhance its biosafety testing service. With the implementation of this rapid PCR testing method, Minaris seeks to minimize the time required for testing lot releases, thus catering effectively to the urgency of the advanced therapies market.

The team at Minaris has successfully validated the BIOFIRE® system for good manufacturing practices (GMP) environments. This rigorous qualification process involved a comprehensive study designed to meet and exceed regulatory scrutiny by closely replicating real-world production conditions. By utilizing a broad spectrum of sample matrices — from in-process cell culture media to final drug products — the capability of BIOFIRE® to detect live, viable mycoplasma strains was meticulously assessed. This approach surpassed earlier qualifications with tighter scientific reinforcement, ensuring greater reliability and regulatory compliance.

Robust Detection Process

The BIOFIRE® Mycoplasma platform is a state-of-the-art closed, automated multiplex PCR system that dramatically reduces the hands-on time required, while simultaneously enhancing accuracy and reliability in test results. The single-use pouch design minimizes human handling, reducing the chances of error, thus bolstering reproducibility and traceability. This innovative system allows Minaris to issue a Certificate of Analysis (CoA) for mycoplasma detection within just three days, a significant improvement that aids in reducing delays associated with batch releases.

Joe Newcome, Senior Director of Analytical Development at Minaris, emphasizes the critical importance of speed in mycoplasma detection, especially with the stringent timelines required for the manufacture of advanced therapies. "By integrating BIOFIRE® Mycoplasma into our services, we are equipping our clients with the means to expedite their development and manufacturing processes while maintaining the integrity of their data and minimizing potential operational risks," he stated.

Enhanced Qualification and Testing Methods

In addition to the rapid detection capabilities provided by the BIOFIRE® system, Minaris offers the ability to perform product-specific qualifications (PSQ) using live mycoplasma spikes. This approach closely simulates real contamination scenarios, thus validating the entire detection workflow end-to-end for more accurate and reliable results.

With the new BIOFIRE® addition, Minaris Advanced Testing now provides three distinct methods for mycoplasma detection:
1. Rapid PCR mycoplasma testing using BIOFIRE® from bioMérieux
2. Mycoplasma DNA Detection by MycoSEQ™ Plus from Thermo Fisher
3. Traditional compendial (EP/JP/USP) culture-based mycoplasma detection (GMP)

This enhancement is significant, building upon years of rigorous experience in both PCR and culture-based testing methodologies. In the event of a positive test result, Minaris has the necessary laboratories available for troubleshooting and precise identification of the contaminant.

Commitment to Quality and Efficiency

The launch of the BIOFIRE® mycoplasma testing service is part of Minaris’ broader strategy to decrease overall development and production timelines across the board for cell therapies. As the demand for safer and more effective therapeutic solutions increases globally, Minaris is committed to applying its advanced technological resources to better serve innovators in the field.

For organizations seeking to navigate the complexities of biotherapeutic development, access to comprehensive and efficient biosafety testing services is vital. Minaris Advanced Testing is now at the forefront of this imperative, offering fit-for-purpose solutions to ensure timely progress from concept to clinic.

For more information, please visit minaris.com and explore the new capabilities provided by Minaris Advanced Testing.