Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.
- May 2026 — CDMO Opportunities And Threats Report
- In Vivo Gene Editing Is Moving From Promise To Proof
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Emergent BioSolutions]( "Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer")
Aseptic Filling Solution Enhances Sterility Assurance for Pharma ManufacturerEmergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
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![GettyImages-1180581753-scientists-lab-monitoring-computer-laboratory]( "Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation System")
Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation SystemLearn how closed-system automation, combined with expert technical guidance and protocol optimization, turned a persistent manufacturing bottleneck into a reliable, scalable process.
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![GettyImages-1225652892-amino-acid-chain-3d-render]( "Surveying Amino Acid Variability Among CHO Media")
Surveying Amino Acid Variability Among CHO MediaVariability in amino acid levels across CHO media can affect growth and product quality. Learn why real-time monitoring and proactive control strategies are key to improving process consistency.
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![GettyImages-2047658928 RNA Protein]( "In Vivo RNA Tuning For Liver Gene Editing Efficiency")
In Vivo RNA Tuning For Liver Gene Editing EfficiencyRNA sequence and guide modifications, delivery platform design, and dose optimization all contribute to improved gene editing outcomes, which offers a clearer path toward safer, more potent, and scalable mRNA-based therapeutics.
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![GettyImages-1087219366-filling-vials-mechanical]( "Why Choose Robotic Processing For Small Batch Aseptic Filling")
Why Choose Robotic Processing For Small Batch Aseptic FillingReducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.
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![GettyImages-1426756188-scientists-in-lab-with-computer-analyzing]( "Monitoring Of A pH Optimization Approach For CHO Cell Cultivation")
Monitoring Of A pH Optimization Approach For CHO Cell CultivationCloud-based monitoring and analytics help centralize data, gain real-time insight, and improve decision-making. Enhanced visibility and collaboration enable faster optimization and consistency across development and manufacturing.
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![GettyImages-1213680755-scientist-gloves-assay-cell-culture]( "Speeding Up Safety: An Evaluation Of Mycoplasma Technology")
Speeding Up Safety: An Evaluation Of Mycoplasma TechnologyRapid mycoplasma testing enhances cell and gene therapy safety by reducing turnaround time, minimizing sample needs, and delivering sensitive, reliable contamination detection across diverse matrices.
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![GettyImages-2181934436-laboratory-analysis-scientists-technology-computer]( "Quantifying Lentiviral Physical Titer Using The QIAcuity dPCR System")
Quantifying Lentiviral Physical Titer Using The QIAcuity dPCR SystemStreamline lentiviral vector analytics with our direct RT-dPCR method. Achieve precise, reproducible results to accelerate safe, effective gene therapies with enhanced quality control.
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![Scientist with DNA copying PCR cycler GettyImages-177381768]( "Performance Comparison Of The Vericheck ddPCR™ Empty-Full Capsid Kit And Analytical Ultracentrifugation (AUC)")
Performance Comparison Of The Vericheck ddPCR™ Empty-Full Capsid Kit And Analytical Ultracentrifugation (AUC)Discover how Droplet Digital PCR (ddPCR) offers a precise analysis of AAV capsid content, outperforming analytical ultracentrifugation (AUC) in distinguishing therapeutic genomes from contaminants.
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![GettyImages-1388281743 pharmacy]( "Addressing A Critical Drug Shortage")
Addressing A Critical Drug ShortageA critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.
NEWSLETTER ARCHIVE
- 06.19.26 -- Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- 06.18.26 -- Tools And Technologies Enabling Next-Generation Cell Therapies
- 06.18.26 -- Scale Vaccine Production With Proven Cell Culture Solutions
- 06.18.26 -- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- 06.17.26 -- What's Slowing Your Cell & Gene Therapy Program?
- In Vivo Gene Editing Is Moving From Promise To Proof
- 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
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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