01.10.26 -- Cell & Gene Best Of December

Join Cell & Gene's Chief Editor, Erin Harris, for this timely Cell & Gene Live offering an in-depth regulatory outlook with two of the field's most trusted experts, Wilson Bryan, M.D., former director of FDA's Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners. Learn More!

Scalable, global-ready CGT manufacturing depends on platformization that tightly integrates MES, ERP, LIMS, and more into a leadership-driven digital backbone that treats data as a strategic asset.

The most complex and expensive drugs to develop often target terrible diseases that affect only a small number of people and will never reach blockbuster status.

The minimum-viable-product concept asks: What's the smallest set of materials or features required to achieve the desired outcome? This principle can bolster sourcing raw materials for gene therapy. 

CMC failures are a top reason for BLA rejections in cell and gene therapy. Learn proactive strategies to spot subtle quality gaps and ensure your manufacturing aligns with strict FDA expectations.

Advancements in high-sensitivity residual DNA testing enhance the precision of plasmid DNA purity analysis, ensuring compliance with regulatory standards critical for manufacturing processes.

Life sciences compliance is complex and ever-changing. Discover how modern solutions can streamline processes, reduce friction, and keep your organization ahead of regulatory demands.