This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CDMO Selection: Start With The Relationship, Not The RFP
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1132960495 EU European Union flag]( "Understanding The EU Regulatory Landscape For Cell And Gene Therapies")
Understanding The EU Regulatory Landscape For Cell And Gene TherapiesEU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.
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![GettyImages-1173740575 computer research data]( "Cell-Free Modeling Approach For Efficient Cell Culture Monitoring")
Cell-Free Modeling Approach For Efficient Cell Culture MonitoringLearn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.
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![GettyImages-1435391920-cell-culture-development-well-plate]( "Perfusion Cell Line Development For Intensified Processes")
Perfusion Cell Line Development For Intensified ProcessesThe biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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![GettyImages-1634050535 data, logistics]( "Expert Insights In Navigating CGT's Complex Supply Chain")
Expert Insights In Navigating CGT's Complex Supply ChainExamine insights shared during Cencora's ThinkLive Cell and Gene Therapy Summit 2024 that shed light on the challenges and opportunities in navigating the complexities of the cell and gene supply chain.
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![GettyImages-1068302874-3d-cells-culture]( "A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived Exosomes")
A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived ExosomesEV production scale increases require paired robust, scalable, and cost-effective downstream processes. Process parameters can be tailored for therapeutic exosome programs and allow for maximum exosome recovery.
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![Corning Ascent FBR]( "Highly Efficient Production Of Adeno-Associated Virus")
Highly Efficient Production Of Adeno-Associated VirusThis study evaluates the performance of a flexible, automated fixed bed reactor (FBR) system during AAV production, comparing it with a similar FBR system and 2D cell culture controls.
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![450_300-high_oxygen_demanding_microorganisms]( "Aerobic Cultivation Of High-Oxygen-Demand Microorganisms")
Aerobic Cultivation Of High-Oxygen-Demand MicroorganismsDiscover how oxygen-enriched conditions and smart feeding strategies boost microbial growth. Prevent oxygen limitation, improve productivity, and maintain control for high-density bioprocessing success.
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "Fast And Accurate Detection Of Alzheimer's Disease Targets")
Fast And Accurate Detection Of Alzheimer's Disease TargetsIn this study, the detection of three Alzheimer’s disease targets are highlighted: Human BDNF (Brain-derived neurotrophic factor), Tau, and TREM2 (Triggering receptor expressed on myeloid cells 2).
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![GettyImages-1067806062-scientist-lab-vaccine-vial]( "Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis")
Quality Assurance In IVT RNA Vaccine Development Using ElectrophoresisDiscover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
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![Car-T cell attacking cancer cell-GettyImages-2252478724]( "CAR T Cell Generation From Cryopreserved Leukapheresis Products")
CAR T Cell Generation From Cryopreserved Leukapheresis ProductsA seven‑day CAR T cell manufacturing workflow shows how cryopreserved leukapheresis material can deliver high viability and strong antitumor activity, offering a more flexible path for production.
NEWSLETTER ARCHIVE
- 06.05.26 -- New Podcast Episodes: Validation Challenges, Rare Disease Drug Commercialization, Redefining CAR-T Timing, and More
- 06.05.26 -- Understanding The Real Risk When Using Research-Grade Material For In-Human Testing
- 06.04.26 -- Next-Gen Precision Control For Cell Therapy Workflows
- 06.04.26 -- Distributed Manufacturing For CGT: Rent, Lease, Or Buy In An Era Of Overcapacity?
- 06.03.26 -- From Gene to GMP: Solving Advanced Therapy's Toughest Manufacturing Challenges
- 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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