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GxP Bioreactor AI for Pharma Industry
- February 17, 2021
- William Payne
Smart factory software developer Aizon has launched a predictive analysis and deep knowledge management tool for the pharmaceutical industry. The Aizon Bioreactor Application provides smart manufacturing capabilities for pharma and Biotech industrial processes.
Aizon says that its software is able to achieve GxP compliance and provide an audit trail from the start of the process.
The application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to predict deviations and outcomes—potentially leading to hundreds of millions of dollars in cost savings and reducing risk.
The software is designed to work with both continuous and fed-batch bioreactors, providing understanding of the customer’s bioprocess manufacturing lifecycle.
The application utilises specialised Edge AI and contextualisation to make the data actionable. Contextualised data is harnessed, 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.”