In May 2023, the FDA published a discussion paper on Artificial Intelligence in Drug Manufacturing, inviting industry feedback and comment. This paper is critical for BioPhorum members as it captures some of the most innovative ways of working, they aim to implement globally.
Our responses have now been published in Industry feedback on artificial intelligence in drug manufacturing: FDA discussion paper.
The FDA offered eight questions against which industry was to provide its feedback, including:
- What types of AI applications do you envision being used in pharmaceutical manufacturing?
- What are the necessary elements for a manufacturer to implement AI-based models in a cGMP environment?
- What are the necessary mechanisms for managing the data used to generate AI models in pharmaceutical manufacturing?
BioPhorum members – both technical and regulatory subject matter experts – were brought together by the Regulatory Governance and External Partnerships team (REGx) to provide the FDA with their views on the current state of implementation of AI in industry. They also discussed their technical and regulatory challenges and their ultimate goal: the real-time release of products in a fully automated plant.
In June 2022, BioPhorum had already identified one of the most challenging topics associated with AI: data integrity for analytical methods that rely on AI for data interpretation, such as next-generation sequencing. This was brought to the FDA’s attention and is a great demonstration of BioPhorum’s forward thinking to see this specific topic addressed in the discussion paper.
As well as providing detailed feedback to the FDA, our paper also presents a global picture of the current state of the biomanufacturing industry on the implementation of AI. It can be used by subject matter experts, business leaders, and key opinion makers to assess their current AI maturity level compared to others and potentially identify future areas of collaboration.