2024 BioMAN Summit

Artificial Intelligence(AI); including techniques such as machine learning (ML), deep learning (DL), and natural language processing (NLP); has the potential to transform the way biologic medicines are manufactured. FDA reported that in 2021 alone, over 100 new drug and biologic license application submissions contained the use of AI and ML, with the areas of AI/ML applications panning the entire product development pipeline, from drug development to post-market surveillance. While FDA continues to develop the regulatory framework for using AI in biomanufacturing, industry must itself prepare their organizations to take advantage of the opportunities presented by these new tools.

As AI applications become more common in biological drug manufacturing, it will also be critically important to ensure that this new technology is being applied correctly by a well-trained workforce, especially as it is used in novel indications.