10.10.26 -- Cell & Gene Newsletter - September

The promise of autoimmune CAR T is enormous, but recent safety pauses from Novartis and BMS underscore why the field needs a more patient-centered approach to risk, clinical outcomes, access, and real-world delivery.

Review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.

In vivo CAR T’s potential to expand access and simplify manufacturing hinges on targeted LNP delivery and solving the durability challenge.

Explore the critical aspects of GMP-grade raw materials in CGT manufacturing, including contamination control, aseptic strategies, quality systems, supply chain security, and regulatory compliance.

Digital PCR offers a precise, scalable approach to lentiviral vector characterization, enabling reliable genome titer, vector copy number, and RCL detection while reducing variability.

Combining automated sampling, real-time PAT monitoring, and cloud-based analytics converts complex bioprocess data into actionable, predictive intelligence to protect every bioreactor batch.