imec.xpand转发了
CAR-Ts and other new therapeutic modalities are becoming increasingly sophisticated, yet their performance tests haven't kept pace ⚠️ As CAR-T therapies evolve, their complexity seems to skyrocket. Dr. Sebastian Kobold's and team nicely described how sophisticated the endodomain architectures of chimeric antigen receptors (CARs) have become (see image at the bottom of this post). But it doesn't stop there, no no. Researchers are now engineering multi-CARs, combining multiple CARs within a single CAR-T. And other new therapeutic modalities like antibody-drug conjugates (ADCs) etc. also keep evolving and getting more and more complex. And this brings me to a pressing challenge 🧐: Current performance testing strategies and quality control assays aren't evolving fast enough to keep up with these advancements. This gap risks underestimating therapy efficacy, complicating regulatory approvals, and potentially delaying groundbreaking treatments from reaching patients. To bridge this gap, we urgently need: 1️⃣ Advanced testing strategies that are compatible with these more complex designs and give a good indication of the potential performance of these new therapies. 2️⃣ Comprehensive, high-resolution characterization methods to accurately capture critical quality attributes (CQAs). 3️⃣ Robust, flexible assays ensuring reliable batch release of these new therapies. To my expert network of scientists, biotech innovators, and regulatory specialists: What innovative solutions are you witnessing or developing to tackle these testing challenges? How have your performance testing strategies evolved to match the therapeutic complexity? I'm especially curious about insights from cell therapies (CAR-Ts, ...) and ADC specialists! 💡 PS: For the original publication, see https://lnkd.in/exMRp877 #CellAndGeneTherapy #CART #ADC #cancervaccines #QualityControl #QC #Biotech #Pharma #AnalyticalDevelopment #GMP #potency imec imec.xpand Bristol Myers Squibb Kite Pharma Gilead Sciences Legend Biotech Johnson & Johnson Novartis Fate Therapeutics Inc. ElevateBio Adaptimmune Juno Therapeutics, Inc. Celgene Autolus Therapeutics Cabaletta Bio CARGO Therapeutics Eureka Therapeutics, Inc Cartesian Therapeutics Poseida Therapeutics, Inc. Roche