LexaGene, a molecular diagnostics company that has commercialised an instrument for automated multiplex PCR testing, has 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.
In July 2021, the 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. Recently, following two deaths in the US, an aromatherapy room spray was recalled due to contamination with Burkholderia pseudomallei (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 aerosolised and made into a bioweapon.
Burkholderia cepacia complex is a problem contaminant for the biopharma industry
B. pseudomallei is endemic in the tropics, has a mortality rate of sometimes greater than 40%, and kills ~90,000 people annually worldwide.
Jack Regan, LexaGene's CEO and Founder said: "LexaGene is increasingly bullish over the opportunities in the biopharma market. The more we talk to this industry, the more we recognise how much value the LexaGene MiQLab System can provide for rapid and sensitive detection of contaminants."
Regan added: "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."
Biopharmaceutical manufacturing companies frequently test for contamination to avoid having a recall, as these events can cost tens of millions of dollars in investigation, cleanup, corrective actions, lost revenue, and manufacturing plant downtime. 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 specialised culture conditions and can be performed immediately - providing results in hours rather than weeks.
The time savings that can be realised, using the MiQLab, 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 has already sold its MiQLab into this industry and continues to expand its offering.