In the world of science, getting accurate and consistent results is key. Thanks to artificial intelligence and automation advancements, achieving this is now easier than ever. Take, for example, the APAS® PharmaQC product from Australian MedTech company LBT Innovations (ASX: LBT). Using AI technology, microbiologists can analyse multiple culture plates. By removing the variability often produced by human microbiologists, maintaining digital records of results, and processing up to 200 plates per hour, it frees up scientists to concentrate on more important tasks.
LBT Innovations functions in the microbiology automation space, highlighting the scope of artificial intelligence. The Company has completed the primary validation for its APAS® PharmaQC product. This milestone represents the final step in product development and technology commercialisation.
CEO & Managing Director, Brent Barnes, said, “Evidence-based automation is incredibly important in the biopharmaceutical industry. The completion of our primary validation is a valuable asset to the Company. We expect this data to build confidence in our technology and assist customers with their adoption of APAS® PharmaQC. Many customers we’ve spoken to over the past six months gave positive feedback on our technological approach and we are looking forward to sharing our primary validation data with them. We have set ourselves an ambitious commercialisation schedule for 2024 and expect the customer qualification pipeline to accelerate as we present our APAS® PharmaQC technology at a number of key global conferences.”
The Company’s main validation program was crafted to meet the standards set by pharmacopeias (books containing directions for identifying compound medicines) for validating different methods of microbiology used in pharmaceutical production.
Analysing and reporting culture plate results during environmental monitoring is crucial for pharmaceutical manufacturers to approve drug products. Enhancing quality control, traceability, and the integrity of data results is also significant in pharmaceutical manufacturing. So, it is standard for potential customers in the pharmaceutical industry to ask for performance data from primary validation.
The successful completion of primary validation for APAS® PharmaQC establishes a substantial body of evidence evaluating the product’s performance against pharmacopeial standards as an alternative microbiology method. Completing primary validation boosts the credibility and trust in APAS® PharmaQC technology. No further regulatory approvals, licenses, or authorisations are necessary for product approval. The technology is now commercially available for global sale.
Key findings from the study include examining over 35,000 plate images, 40,000 reads by microbiologists, and counting approximately three million colonies. The study evaluated nine different microbial organisms across various operational conditions and practices. The technology successfully achieved all performance targets, with a 0% Qualitative False Negative Rate for detecting microbial growth and showing high accuracy and linearity in counting standard organisms.
The completion of primary validation and the product’s formal release marks the development project’s conclusion with AstraZeneca, a biopharma company. AstraZeneca will now conduct an internal secondary validation of the system within its manufacturing processes, which is expected to be completed in the third quarter of CY24.
In February, the Company reported its first sale of the product. It delivered an APAS® Independence instrument with APAS® PharmaQC software to a Thermo Fisher facility in Adelaide, reflecting the positive market interest from pharmaceutical customers following initial market development activities.
In H1 FY24, the Company reported a revenue of $711k, supported by AstraZeneca’s investment in product development. LBT’s cash position improved from $2 million to $3.2 million.
While some individuals may worry that AI will replace jobs, for others, it’s clear that AI can simplify their work, enabling them to accomplish more in less time.
Alinda is a Business Reporter for The Sentiment
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