LexaGene Holdings Inc said it has successfully expanded its biopharmaceutical contamination panel by developing a Burkholderia test for use on its MiQLab system.
Burkholderia cepacia complex, a group of about 24 related environmental bacteria, is a problem contaminant for the biopharma industry. B. cepacia is the most common microbial contaminant in nonsterile pharmaceutical products, accounting for up to 39% of product contamination.
The Beverly, Massachusetts-based company said that the Food and Drugs Administration (FDA) advised drug manufacturers to test for Burkholderia, which has increasingly been found to be the cause of recalled products, including a skin gel, an ultrasound gel, and a mouthwash earlier in July.
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“LexaGene is increasingly bullish over the opportunities in the biopharma market. The more we talk to this industry, the more we recognize how much value the LexaGene MiQLab System can provide for the rapid and sensitive detection of contaminants,” said Dr. Jack Regan, LexaGene’s CEO.
"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,” he added.
Recently, following two deaths in the United States, an aromatherapy room spray was recalled due to contamination with Burkholderiapseudomallei (B. pseudomallei). This bacterium is classified by the Centers for Disease Control and Prevention (CDC) as a Tier 1 biothreat agent, because it can be easily aerosolized and made into a bioweapon. B. pseudomallei is endemic in the tropics, has a mortality rate of sometimes greater than 40%, and kills over 90,000 people annually worldwide.
Biopharmaceutical manufacturing companies frequently test for contamination to avoid having a recall, as these events can cost tens of millions of dollars in the investigation, cleanup, corrective actions, lost revenue, and manufacturing plant downtime.
The biotech technology company said that the list of possible biopharma contaminants is long, with many requiring custom culture conditions for optimal growth. Even under optimal growth conditions, some contaminants take up to 28 days for testing.
In contrast, PCR-based testing does not require specialized culture conditions and can be performed immediately, providing results in hours rather than weeks. MiQLab can save time and can have massive implications for biopharmaceutical manufacturers by allowing them to more quickly identify contaminants before they result in millions of dollars in losses.
LexaGene’s MiQLab System has already been tested and proven to work well on some of the most common cell lines and products manufactured in the industry.
LexaGene is a molecular diagnostics company that develops systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety, and for use in open-access markets such as clinical research, agricultural testing, and biodefense.
Contact Ritika at ritika@proactiveinvestors.com