LexaGene Holdings, Inc., a molecular diagnostics company that develops fully automated, rapid pathogen detection systems, has successfully utilized the MiQLab™ System to detect the presence of a slow growing bacterium, responsible for millions of dollars of damages to biopharmaceutical manufacturers.
Dr. Jack Regan, LexaGene’s CEO and Founder stated, “Last fall, a global biopharmaceutical manufacturer contacted LexaGene and purchased a MiQLab System as they wanted to improve their already stringent quality assurance program centered around their bioreactor work. This manufacturer continues to regularly use the MiQLab System. As a result of discussions with this customer, LexaGene is working to expand the number of targets included in its bioreactor contamination panel and we expect our efforts supporting this customer and the industry in general will drive additional sales this summer.”
Dr. Regan added “The biopharmaceutical manufacturing sector is rapidly growing and continues to ramp up to meet global demand for vaccines, monoclonal antibodies, and therapeutic proteins. The MiQLab System, using its fully automated sample preparation and PCR technology, can screen a sample taken from a bioreactor for multiple contaminants that could negatively affect a manufacturing line. In comparison to standard lab-based testing methods, the MiQLab System can return reliable results in a fraction of the time.”
Contamination within bioreactors is a common occurrence as it is dependent on mammalian culture. It is critical to keep bioreactors free of unwanted microorganisms. Vaccines made from culture must be free of microorganisms for safety and contaminated batches must be destroyed. Recently, Emergent Biosolutions had to discard 15 million doses of the Johnson & Johnson Covid-19 vaccine due to quality issues when it was most needed in order to ensure a safe vaccine supply.
Microbial contamination has been responsible for vaccine recalls and vaccine scarcity highlighting the need for rigorous contamination testing during manufacturing process. One of the more common contaminants in bioreactors is Cutibacterium acnes (C. acnes), a commensal bacterium on human skin. The shedding of dead skin cells from those maintaining bioreactors is a common source of contamination with C. acnes. Not only is it common, but it is also one of the hardest microorganisms to detect, because it grows very slowly; taking a minimum of three days when starting from ideal laboratory conditions and up to two weeks when starting from a contaminated bioreactor sample. This very long growing time has a massive negative impact on contract manufacturers experiencing loss of very expensive products due to this contamination.
To minimize the impact of C. acnes on product stability and conformity, rapid testing is needed during each of the four main phases of manufacturing, including testing: the raw materials that go into bioreactors, the seed cultures before transfer to a bioreactor, the small bioreactor material being scaled up to a larger bioreactor, and the final product prior to sending it to the customer. Quickly identifying contamination during each of these steps minimizes profit losses that are often assumed and built-in to cost estimates for the manufacturer. Better testing also gives the manufacturer more confidence in meeting their delivery timelines for the customer.
Dr. Nathan Walsh, LexaGene’s Vice President of Applications & Bioinformatics added, “We are pleased to announce that LexaGene completed a study on C. acnes using the MiQLab System. In this benchmark study, C. acnes was diluted in media down to extremely low levels (below the limit of detection) and cultures were grown for 24 hours to mimic growth in a bioreactor. Samples were then collected for MiQLab processing and agar plating, where the plates were incubated under ideal conditions and regularly monitored for signs of countable colonies. Colonies on the plate were not observable until three days after plating. In contrast, the MiQLab successfully detected 100 percent of the samples in just two hours.”
Dr. Walsh concluded, “In real-world testing, the time benefit of using the MiQLab System over culture may be greater than our laboratory study as it generally takes two full weeks for primary C. acnes cultures to grow from a bioreactor sample. Given the MiQLab can detect this bacterium in just two hours, this represents a 168-times improvement in time-to-result. Such a drastic time savings would potentially save manufacturers a significant amount of money as they could more quickly identify contaminated cultures.”
On June 17, Dr. Jack Regan, CEO and Founder of LexaGene, presented at the Biothreat and Pathogen Detection Conference regarding the MiQLab System’s ability to detect the pathogen that causes plague. Plague has caused numerous pandemics in human history and is classified by the government as a Category A Bioterrorism agent. In order to demonstrate the MiQLab’s capabilities for biothreat agent detection, LexaGene developed a plague test and completed an analytical evaluation with contrived samples.