LexaGenesPCR Solution to Expand Biopharma Contamination Panel

LexaGenesPCR Solution to Expand Biopharma Contamination Panel

Healthcare Tech Outlook | Friday, November 26, 2021

In the biopharma industry, the LexaGeneMiQLab solution can offer rapid and sensitive identification of contaminants to avoid having recalled products.

Fremont, CA: Contamination is routinely tested by biopharmaceutical manufacturing companies to avoid having to issue a recall, which can cost tens of millions of dollars in investigation, cleanup, remedial actions, lost income, and manufacturing facility downtime.  The list of potential bio-pharma contaminants is long, and many of them require special culture conditions to thrive. Even under ideal growing circumstances, testing for some pollutants can take up to 28 days. PCR-based testing, on the other hand, does not require specialized culture conditions and may be done right away, yielding results in hours rather than weeks.

LexaGene Holdings, a molecular diagnostics business that has commercialized anautomated multiplex PCR testing equipment, has effectively expanded its biopharmaceutical (bio-pharma) contamination panel by producing a Burkholderia1 test for use on their MiQLab System. The time savings obtained by adopting the MiQLab can have huge ramifications for biopharmaceutical firms, allowing them to discover contaminants more rapidly before they cause millions of dollars in losses.

The biopharmaceutical industry is looking for more versatile PCR solutions that can handle complicated matrices and provide results rapidly. The LexaGene'sMiQLab System has previously been tested and proved to function with some of the industry's most prevalent cell lines and products. LexaGene has already sold its MiQLab to this industry and is continuing to grow its product line.

Dr. Jack Regan, LexaGene’s CEO and Founder, states, "LexaGene is increasingly bullish over the opportunities in the bio-pharma market. The more we talk to this industry, the more we recognize how much value the LexaGeneMiQLab System can provide for rapid and sensitive detection of contaminants. To meet the new FDA recommendations, we have quickly developed a genus level Burkholderia test that can also detect the rare events of contamination with the biothreat agent B. pseudomallei and continue to develop other tests to provide the best, most complete, multiplexed PCR testing solution for this industry."

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