LBT Innovations (ASX:LBT) has announced the successful completion of primary validation for the APAS PharmaQC product.
The company is a leader in microbiology automation using artificial intelligence. It said completion of the milestone represents the final step in product development and technology commercialisation.
Culture plate reading and reporting during environmental monitoring is a critical step for pharmaceutical manufacturers to release drug products. Improving quality control, traceability, and data integrity of results is essential in pharmaceutical manufacturing. It is common practice in the pharmaceutical industry for prospective customers to request primary validation performance data.
LBT said the successful primary validation of APAS PharmaQC establishes a significant body of evidence that assesses the product's performance against pharmacopeial requirements as an alternative microbiology method.
It said completion of primary validation and formal release of the product finalises the development project with AstraZeneca. AstraZeneca will now undertake an internal secondary validation of the system within its own manufacturing processes. Completion of AstraZeneca's secondary validation is anticipated in the third quarter of calendar year 2024.
LBT CEO and 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 6 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."
