Clever Culture expands pharma reach on validating smaller APAS contact plate

• Clever Culture completes validation of new APAS 55mm contact plate
• New analysis module expands market opportunity for APAS tech in pharmaceutical manufacturing sector
• APAS contact plate analysis module now offered as an additional analysis module on the APAS Independence platform

Special Report: Leaders in AI microbiology automation Clever Culture Systems has achieved a major catalyst in validating its new, smaller APAS 55mm contact plate on the APAS Independence platform, with the analysis module now available for sale.

The validation significantly expands the market opportunity for the Clever Culture Systems (ASX:CC5) proprietary APAS technology in pharmaceutical manufacturing, where contact plates are widely used to monitor production environments.

Successful completion of the APAS contact plate analysis module validation marks the final milestone ahead of its commercial launch.

Clever Culture said the formal validation study was conducted meticulously to meet pharmacopeial requirements and confirmed the system’s suitability as an alternative microbiological method, providing customers with confidence to adopt the technology.

More than 20,000 plate images and microbiologist plate reads were analysed with all performance targets achieved in line with pharmacopeial guidelines.

The primary performance target was reached with a 0% false negative rate meaning no plates with organism growth were missed by APAS Independence.

Complete solution for pharma environmental monitoring

Pharmaceutical manufacturing relies on the use of settle plates (90mm) and contact plates (55mm) to monitor production environments including air, surfaces and personnel for potential microbial growth.

CEO and managing director Brent Barnes said validation of Clever Culture’s APAS contact plate analysis module expanded the overall market opportunity for APAS Independence in the pharmaceutical market.

“With this development complete, APAS® Independence can now automate the majority of environmental monitoring tests in routine sterile drug manufacturing, expanding the addressable market and increasing the potential revenue per instrument sold,” he said.

Its unique capability further strengthened the competitive differentiation of APAS Independence, he said, positioning the technology as the most comprehensive and scalable solution in pharmaceutical environmental monitoring.

Rollout starts of 55mm contact plate

The APAS contact plate analysis module is now offered as an additional analysis module on the APAS Independence platform, creating an increased recurring revenue stream.

In addition, upgrade kits are available for existing customers, creating further revenue opportunities from the established APAS Independence installed base

Upgrade orders are expected to be fulfilled with existing customers over the coming months, representing near-term sales opportunities following the application being finalised.

Clever Culture has already generated an active pipeline of sales opportunities for APAS Independence in the pharmaceutical market with more than 40 qualified opportunities, representing an estimated 150+ APAS instrument sales.

The company said this included ~60-80 APAS instrument sale opportunities with existing APAS customers.

Clever Culture now counts five top-tier pharmaceutical customers that are either evaluating or already using APAS.

These include AstraZeneca, Bristol Myers Squibb, Thermo Fisher Pharma Services, Novo Nordisk and an unnamed multinational that recently completed a major settle plate evaluation.

The availability of the contact plate application is expected to accelerate traction with these customers who are seeking a complete automation solution for the environmental monitoring plate workflow.

“Combined with the growing industry recognition and adoption of our technology, this enhancement is expected to further accelerate uptake across pharmaceutical manufacturing customers,” Barnes said.

“Early rollouts with select customers have already been completed, providing valuable feedback and reinforcing the substantial market demand for this capability.”

‘Enabling greater automation of environmental monitoring’

Clever Culture chief scientific officer Dr Steven Giglio said performance of the 55mm contact plate application was equally impressive as the 90mm settle plate application.

“This achievement is a testament to the dedication of the entire CCS development team, not only in delivering the analysis module application, but also in developing the hardware required to handle this smaller plate type,” he said.

“Beyond being a technical milestone, this functionality offers tangible benefits to our customers, enabling greater automation of environmental monitoring, improving quality and traceability of critical results while enhancing operational efficiency.

“It also opens new opportunities for broader adoption of the APAS technology across pharmaceutical manufacturing sites, reinforcing the company’s commitment to meeting customer needs and driving market growth.”

Development of the APAS 55mm contact plate application was part-funded under MTPConnect’s Clinical Translation and Commercialisation Medtech program, which is part of the Australian Government’s Medical Research Future Fund.

This article was developed in collaboration with Clever Culture Systems, a Stockhead advertiser at the time of publishing.

 This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.