LexaGene Detects a Slow-Growing Bacterium at Least 36-Times Faster Than Conventional Methods With Potential to Increase Vaccine Safety & Supply

LexaGene Holdings, Inc. recently announced it 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, said “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 3 days when starting from ideal laboratory conditions and up to 2 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% of the samples in just 2 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 2 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.”

LexaGene is a molecular diagnostics company that develops molecular diagnostic 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. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press “go.” The MiQLab system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately two hours. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.