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-513110674 lab, research, sample, vial]( "Navigating CMC Regulation For Plasmid DNA In Gene Therapy")
Navigating CMC Regulation For Plasmid DNA In Gene TherapyExplore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
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![450_300-microalgae_cultivation]( "Phototrophic Cultivation Of <em>Chlorella vulgaris</em> In Microbioreactors")
Phototrophic Cultivation Of Chlorella vulgaris In MicrobioreactorsUnlock efficient microalgae cultivation with precise lighting and real-time insights. Explore ways to boost biomass, optimize growth, and accelerate sustainable bioenergy and bioproduct innovation.
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![GettyImages-1787595822-virus-viral-bacteria-cell]( "Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy")
Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene TherapyHereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.
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![GettyImages-1142684567 cell culture]( "A Beginner's Guide To Sf9 Culture In Stirred-Tank Bioreactors")
A Beginner's Guide To Sf9 Culture In Stirred-Tank BioreactorsLearn about the workflow steps for Sf9 cell expansion, virus preparation, and protein production in stirred-tank bioreactors, including GFP expression.
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![GettyImages-1356993441 mRNA]( "Enhancing Safety And Efficacy Of mRNA-Based Therapeutics")
Enhancing Safety And Efficacy Of mRNA-Based TherapeuticsDiscover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.
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![Operator loading nested vials into Microcell vial filler]( "CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics")
CDMO Uses Robotic Gloveless Isolator For Advanced TherapeuticsCDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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![GettyImages-1066989062-gene-cell-doctor-research]( "Vial Adapter Transfer Device Compatibility With Cell Therapies")
Vial Adapter Transfer Device Compatibility With Cell TherapiesNeedles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
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![Eppendorf - Bioflo control station]( "Large-Scale Exosome Production Stirred-Tank Bioreactors")
Large-Scale Exosome Production Stirred-Tank BioreactorsDiscover how engineered exosomes, displaying tumor-homing peptides, offer a promising tool for targeted cytotoxic drug delivery, produced efficiently with a bioreactor for critical research.
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![GettyImages-1435391920-cell-culture-development-well-plate]( "Seed Train Intensification Using High Cell Density Cryopreservation")
Seed Train Intensification Using High Cell Density CryopreservationStreamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.
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![GettyImages-675822742 bioreactor]( "Addressing The Challenges In Lentivirus Harvest Clarification")
Addressing The Challenges In Lentivirus Harvest ClarificationTraditional depth filtration struggles with lentiviral harvest clarification, leading to low yields and high costs. However, single-use centrifugation offers a promising alternative.
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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