Manufacturing software specialist Aizon has launched an AI application to bring bioreactor processes into a smart manufacturing framework in pharma and biotech industries. The Bioreactor Application can achieve GxP compliance and provide an audit trail from the start of the process.

The turnkey application allows pharmaceutical and biotech companies to employ complex datasets generated during upstream manufacturing to detect and predict deviations and outcomes —- potentially leading to hundreds of millions of dollars in cost savings, reduced risk, and additional revenue upside.

Able to work with both continuous and fed-batch bioreactors, the application employs specialised Edge AI and contextualisation, which is a requirement to make the data actionable. Contextualised data is analysed and visualised through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.

AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application.

“It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyse complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimise bioreactor processes in commercial manufacturing.”

Aizon’s CEO, John Vitalie said, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialisation of their digital solutions. We see that this is key for pharma and biotech to realise the vision of smart manufacturing and accelerate their progress toward realising the promise of the adaptive plant.”