Molecular diagnostics company LexaGene Holdings has signed a statement of work with a major biopharma company.
This comes a week after the same biopharma company purchased one of LexaGene’s commercialised MiQLab systems.
Dr Jack Regan, LexaGene’s CEO and Founder, said: “This company has agreed to have the validation work done at LexaGene, and they will have a scientist embedded onsite during parts of the study. The biopharma company will provide some bio-reactor samples that are required for the study.”
The technology validation study outlined within the signed statement of work will provide this biopharma company much of the data they need to make future decisions in just a few weeks of time.
These slow turnaround times prevent them from detecting contamination events before losses become substantial. Furthermore, many common contaminants such as different viruses and fungi are very difficult or impossible to culture
Dr Regan continued: “If the data generated during this validation study meets this biopharma company’s needs, and our technology is adopted for in-process testing, we believe a single manufacturing plant would generate millions of dollars in revenue annually for LexaGene. This biopharma company operates many manufacturing plants both domestically and worldwide.”
Single manufacturing plants of large biopharma manufacturers generate products worth hundreds of millions of dollars every year. It is not uncommon for manufacturing plants to experience 5 – 10 contamination events per year.
Dr Regan concluded: “Current testing technologies rely on culture, which can take 28 days to generate results. These slow turnaround times prevent them from detecting contamination events before losses become substantial. Furthermore, many common contaminants such as different viruses and fungi are very difficult or impossible to culture. As a result, many biopharma companies are looking towards automated multiplex PCR solutions to meet their testing needs and we believe our MiQLab System is an ideal solution.”