AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- Managing Supply Disruptions In ATIMP Clinical Trials
- Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
- CGT Manufacturing Shifts From Capacity To Strategy
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![T-Cells Work to Fight Cancer, Immunotherapy, CAR T-cell therapy-GettyImages-1317697233]( "Spatial Organization Of The CAR Is Critical For CAR T Cell Function")
Spatial Organization Of The CAR Is Critical For CAR T Cell FunctionExplore how advanced single‑cell analysis links CAR localization, cell structure, and functional behavior, offering deeper insight into CAR T cell heterogeneity and performance.
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![mRNA GettyImages-1356994684]( "Best Practices For Analysis Of IVT mRNA")
Best Practices For Analysis Of IVT mRNADiscover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.
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![GettyImages-1832921718-pills-medicine-blue-background]( "Automated Testing For Compound Toxicity Effects")
Automated Testing For Compound Toxicity EffectsExplore how anti-cancer drugs' toxic effects on intestinal cells limit dosages as well as how 3D organoids and assay automation can enhance drug development by improving testing processes.
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![Scientist Using Tablet In Lab GettyImages-1354172577]( "384-Well Microplate Time Resolved Fluorescence (TRF) Immunoassay")
384-Well Microplate Time Resolved Fluorescence (TRF) ImmunoassayExamine how innovative sandwich ELISAs in a 384-well format can be utilized with a sensitive reader for high-throughput screening to quantify Human IgG and IFN gamma.
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![Cryoport - advanced solutions]( "BioServices: Advanced Solutions For Cell And Gene Therapy Material Management")
BioServices: Advanced Solutions For Cell And Gene Therapy Material ManagementSee how supply chain solutions like BioServices can help companies mitigate risk to their overall supply chain while saving valuable capital for the research of their lifesaving therapies.
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![GettyImages-1002000796-lab-research-scientist-development]( "Highly Sensitive ELISAs In 90 Minutes")
Highly Sensitive ELISAs In 90 MinutesTraditional ELISA methods are often limited by their relatively low throughput and need for multiple wash steps. Learn about a solution that overcomes these challenges and provides rapid results.
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![GettyImages-2200128716-software-ai-machine-learning-percentages-code]( "Building Digital Capabilities For An Intelligent Tomorrow")
Building Digital Capabilities For An Intelligent TomorrowExplore how modern manufacturing software is transforming operations with AI-driven insights to empower CDMOs and CMOs to boost efficiency, agility, and client satisfaction in a competitive landscape.
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![GettyImages-1341292033-tablet-cleanroom-equipment-protective-gloves]( "Cleanroom Recovery. Proven Results. Contamination Control Case Studies")
Cleanroom Recovery. Proven Results. Contamination Control Case StudiesThrough this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.
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![GettyImages-2150364155-hand-digital-documents-validation]( "Mid-Sized Pharma Optimizes Local Affiliate Safety Operations")
Mid-Sized Pharma Optimizes Local Affiliate Safety OperationsManaging local affiliate PV strains any team. See how a mid-sized biopharma standardized ICSR processing across 94 countries, improved compliance tracking, and achieved centralized oversight.
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![Eppendorf - CGT brochure]( "Tackling CGT Challenges: Stirred-Tank Bioreactors For R&D And Commercial Manufacturing")
Tackling CGT Challenges: Stirred-Tank Bioreactors For R&D And Commercial ManufacturingScalability remains a key bottleneck in CGT manufacturing. See how optimized stirred-tank bioreactor systems accelerate translation from clinical to commercial production.
NEWSLETTER ARCHIVE
- 06.04.26 -- Next-Gen Precision Control For Cell Therapy Workflows
- 06.03.26 -- From Gene to GMP: Solving Advanced Therapy's Toughest Manufacturing Challenges
- 06.03.26 -- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- 06.02.26 -- STREAM Edition: Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- 06.02.26 -- Why the Right Manufacturing Partner Is About More Than Capacity
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
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