Cell & Gene Therapy Insights

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...

“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 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.

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.

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As iPSC-derived cell therapies progress through clinical development, sessions at the summit will examine first-in-human experiences and advancing data across Parkinson's disease and ocular indications, with a focus on safety, engraftment, durability, and functional outcomes. Ron Cohen (Chief Executive Officer, Oryon Cell Therapies) will offer an inside look at how Oryon is advancing autologous iPSC-derived dopaminergic neurons in Parkinson's disease.

Next-generation armored CAR-T cells — engineered with IL-12, PD-L1 blockade, and oncolytic virus antigen delivery — offer new strategies to overcome the immunosuppressive solid tumor microenvironment.

What you will learn 01 Why the −1 °C/min benchmark only holds within controlled-rate systems with active phase transition management – not in static freezers that happen to reach the same rate 02 How phase transition control reduces variability ~14-fold vs static freezing (CV 2.3% vs 32.6%), and why this interval is the period of greatest osmotic and mechanical stress on cells 03 How plate-based and cryogenic LN2 freezing systems with user-defined recipes deliver reproducible, high-viability...

Advanced tools and scientific breakthroughs are making the word 'undruggable' obsolete, while human-centered deal-making and innovative business models are set to dominate the coming years in the pharmaceutical industry. UK Biotech Day 2026 takes place at a time of real structural pressure across the life sciences sector.

What you will learn 01 How a precompetitive consortium can standardize shared domains – referral criteria, accreditation, registry architecture – while preserving sponsor-specific CMC and proprietary procedures 02 How a two-tier delivery network (Tier 1 regional hubs and Tier 2 accredited satellite centres) supported by tele-proctoring can expand procedural capacity equitably 03 How parallel regulatory engagement, outcomes-based reimbursement, workforce credentialing, and a mandatory registry...