Dallas, Texas – November 28, 2023 – LexaGene Life Sciences, an innovative, molecular diagnostics company that is commercializing its MiQLab System for automated, microbial contamination testing, is providing the following update on the Company’s efforts in development of the 2nd generation MiQLab System for adoption for routine testing during the manufacturing of biologics.
The Company continues engagement with two traditional biopharma customers that purchased the 1st generation MiQLab system in 2022 Individuals in both organizations have indicated to the company through ongoing discussions that our technology has the potential to benefit their respective companies and that our technology can be of great value to the entire industry.
In the process of completing feasibility studies in early 2023 with the two biopharma customers, through this work, the company was able to make a ~500X improvement in sensitivity for Mycoplasma, according to Dr. Jack Regan, the company’s Chief Technology Officer.
Mycoplasma contaminates 15 – 80% of U.S. laboratory cell cultures.1 Confirming a culture, or a biopharmaceutical biologic is negative for contaminating Mycoplasma takes 28 days by current methods.2 This delay not only shortens the time available to sell the product before expiration, but also puts the biopharma company at more risk during the 4 – 6 weeks of bioreactor growth. At these latter stages, there could frequently be 10’s of millions of dollars’ worth of product at risk should a contamination be detected. Furthermore, it is critical for biopharmaceutical manufacturers to have robust procedures for monitoring and controlling the biosafety of their processes to ensure patient safety and compliance.
The industry is looking to adopt an easy-to-use PCR-based technology that can be operated inside the manufacturing plant which provides extremely sensitive detection in just a few hours. Manufacturers want the ability to detect contaminations in raw materials and across each bioprocessing step, especially the most expensive and value-adding steps. We believe the data generated for the two biopharma customers study demonstrated LexaGene’s MiQLab System can be configured for extremely sensitive applications such as detecting Mycoplasma. These feasibility studies add to the body of data we’ve already generated that gets us closer to our technology being adopted for the manufacturing stage of producing biologics.
For more information about LexaGene and the MiQLab System, please visit www.lexagenelifesciences.com
LexaGene Life Sciences, LLC
LexaGene is a molecular diagnostics company that has commercialized the MiQLab System for fast and easy detection of biological contaminants, pathogens and other molecular markers. The System is designed for on-site usage and uses real-time PCR chemistry.