Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.
- 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
- Rethinking CQV In A Digital, Agile Manufacturing Landscape
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1346675635-laboratory-analysis-research-microscope]( "Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation")
Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With AutomationGrowing oligonucleotide complexity is straining traditional analytical workflows. See how automated LC‑UV‑MS processing offers a scalable way to boost throughput and reduce manual effort.
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![GettyImages-2163606903-gloves-pipet-cell-culture-assay]( "Rapid Selection Of High-Performance CHO Basal And Feed Media")
Rapid Selection Of High-Performance CHO Basal And Feed MediaA CHO-S bispecific antibody program needed a better basal and feed media combination. Learn how the screening of 180 conditions in 12 weeks identified one that delivered 38% higher titers.
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![GettyImages-1181392775 lab, research]( "Predicting Antibody-Dependent Cell-Mediated Cytotoxicity")
Predicting Antibody-Dependent Cell-Mediated CytotoxicityWe developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.
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![Assessing Particle Generation In A Single-Use Mixing System]( "Assessing Particle Generation In A Single-Use Mixing System")
Assessing Particle Generation In A Single-Use Mixing SystemExplore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.
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![cell-gene-therapy-GettyImages-2157300524]( "21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?")
21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.
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![Pharma Manufacturing GettyImages-1135140594]( "The State Of Digital Maturity In Pharma And Medtech Manufacturing")
The State Of Digital Maturity In Pharma And Medtech ManufacturingExplore results from a study aiming to understand why numerous companies continue to rely on manual, paper-based systems, and gain insight into how your competitors are gaining a competitive advantage.
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![GettyImages-1871216402-anaerobic-cultivation-of-probiotics]( "Anaerobic Cultivation Processes Of Probiotic Bacteria")
Anaerobic Cultivation Processes Of Probiotic BacteriaCultivate oxygen-sensitive probiotics with precision using real-time monitoring, microfluidic feeding, and pH control for reproducible growth and optimized microbiome and fermentation research.
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![mRNA GettyImages-1428646288]( "Suitability Testing For IVT mRNA Analysis")
Suitability Testing For IVT mRNA AnalysisAutomated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.
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![Scientists taking samples with pipette-GettyImages-1327977866]( "Master The Art Of Pipetting And Learn How To Perform Serial Dilutions")
Master The Art Of Pipetting And Learn How To Perform Serial DilutionsAccurate serial dilutions depend on more than calculations. Learn how mixing, tip handling, and workflow consistency influence accuracy, as well as how small adjustments can improve reproducibility.
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![GettyImages-1218745370 cleanroom, disinfecting, lab]( "Contamination In The Shadows: Risks Lurking From Environmental Issues")
Contamination In The Shadows: Risks Lurking From Environmental IssuesDiscover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.
NEWSLETTER ARCHIVE
- 06.01.26 -- Cut Variability, Raise Titers, And Scale With Confidence
- 06.01.26 -- CGT Manufacturing Shifts From Capacity To Strategy
- 05.29.26 -- Securing Your Advanced Therapy Pipeline
- 05.29.26 -- Materials Matter: Reframing Raw Material Strategy In Cell And Gene Therapy Development
- 05.28.26 -- Accelerate Your Assay And Imaging Data With These New Tools
- 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
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
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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