Cell & Gene Therapy Insights

“The datasets underpinning CGT workflows, and the infrastructures that generate and connect them, must become AI-worthy before AI can matter at scale.” AI is widely positioned to transform cell and gene therapy (CGT), but its impact is limited less by an algorithmic deficit than by an AI-worthiness’ deficit: the field’s fragmented and poorly documented datasets are rarely governed, interoperable, and provenance-aware enough to support trustworthy AI.

“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),...

Cell & Gene Therapy Insights 2026; 12(6), 623–641 DOI: 10.18609/cgti.2026.074 CAR‑T cell therapy has revolutionized the treatment of hematologic malignancies, but associated manufacturing presents logistical and clinical challenges that can impact product quality while limiting scalability and equitable patient access. Cryo‑processing of starting material is enabling greater manufacturing flexibility and scheduling, critical for global CAR‑T therapy deployment.

What you will learn 01 How continuous, real-time glucose and lactate monitoring outperforms manual sampling in ATMP manufacturing, cutting operator burden and contamination risk 02 How a PID-controlled feed strategy held glucose at a 5.5 mmol/L physiological set point in a functionally closed bioreactor for personalized tissue-engineered arteries 03 Key lessons for stable control: optimized controller tuning, frequent auto-calibration, and membrane selection to limit protease interference and...

June delivered a landmark for the CAR-T field alongside a distinct shift in US regulatory posture. CARsgen secured NMPA approval for satri-cel, the first CAR-T cell therapy approved for a solid tumor indication anywhere in the world, targeting Claudin18.2 in advanced gastric and gastroesophageal junction adenocarcinoma.

CAR-T cell therapy enters its next decade with hard-won momentum and unresolved challenges in equal measure. The science is advancing. The system has not yet caught up. Closing that gap, on access, on reimbursement, on regulatory engagement, will define whether the promise of CAR-T is realized for the many or remains out of reach for the patients who need it most.

Key findings The HiPer™ QA resin achieves high salt tolerance and resolution of empty and full AAV capsids The purpose-built QA resin demonstrates lot-to-lot consistency, resulting in improved development costs Resin performance remains consistent regardless of flow rate, while also maintaining AAV separation efficiency even with 15 seconds residence time The HiPer QA resin enables efficient separation of AAV9 variants under high-conductivity buffer conditions Summary The micrometer-scale...

Cell and Gene Therapy Insights 2026; 12(6), 577–588 10.18609/cgti.2026.071 As CAR‑T therapies move toward larger‑scale and GMP manufacturing, robust analytical strategies are increasingly critical for ensuring product safety, consistency, and regulatory readiness.

“In a regulatory policy role, it is that curiosity that is important for keeping up with ever‑developing technologies: knowing what is out there, how it works, and what the potential side effects are.” Wil Rich, Editor, Cell & Gene Therapy Insights , speaks with Eddie Tan Han Pin, Assistant Professor, Centre of Regulatory Excellence, Duke‑NUS Medical School, about his career journey from molecular cancer biology through GMP manufacturing and regulatory science into health policy, the evolving...

Cell & Gene Therapy Insights 2026; 12(6), 563–575 DOI: 10.18609/cgti.2026.070 “...anticipate unexpected questions, take a hard look at your data, and try to assemble some experts to pick it apart before submission.” Early analytical decisions in cell therapy can influence the entire development pathway, from IND readiness and CDMO transfer to BLA submission and commercial scale‑up.