June 5, 2024

How To Implement AI in GMP Manufacturing - CDMO Live Interview

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Last May, Claus Abildgren (Aizon's CRO) and David O'gara (Aizon's Advisor) were interviewed by Chris Kilbee in the context of PharmaSource's lighthouse event for the pharma manufacturing industry, CDMO Live. In this event, PharmaSource bridges the gap between offer and demand in the industry by bringing top CDMOs and pharma outsourcing responsibles on the same table.

In this enlightening conversation, Claus highlights the need for "pragmatic steps towards enhancing manufacturing performance through practical applications". He emphasized that Aizon aims to evolve the industry by optimizing manufacturers' capacity and using AI to anticipate and mitigate adverse events. Ensuring data integrity and maintaining audit trails are crucial in deploying technology in a regulated environment.

David O'gara added that leveraging plant data can improve yields, ensuring timely, high-quality production at reasonable costs. Automated quality reports can reduce the workload for quality organizations and production chemists. Deploying this technology at CDMOs can yield substantial returns, especially with high-value molecules where even a 1% improvement can significantly impact ROI.

Aizon’s software undergoes rigorous validation to address drug production complexities, maintaining close communication with regulatory agencies like the FDA. The future will see inspectors reviewing batches through new assessment methods rather than on paper.

David advises starting with small opportunities due to regulatory constraints, recommending incremental digital solutions targeting specific areas. One practical area is digitizing paper batch records, where Aizon Execute can play a pivotal role.

Transparent information sharing will be pivotal for accelerating technology transfers but will challenge relationships between pharma companies and contract manufacturers, requiring foundational trust and a mature approach to collaboration.

You can hear the full interview here: Aizon Podcast

You can also read the original article here: PharmaSource Article