What CGT can learn from biologics: high‑value AI use cases for manufacturing

“Biologics may not provide an exact solution that can be adopted in CGT as‑is, but they certainly act as a guide that can be used in CGT with appropriate modifications.”

Cell and gene therapy manufacturing continues to face efficiency and scalability challenges, yet the sector can draw directly on the biopharmaceutical industry’s established experience applying AI and machine learning across biologics production, spanning digital infrastructure, process analytical technology (PAT), cloud-based digital applications, and generative AI. This article examines how those lessons translate to CGT, arguing that manufacturers should prioritize electronic batch records, contextualized metadata, and cloud-based data pipelines before layering on advanced AI, while planning early for GMP validation of AI-driven tools.

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