Case studies reveal the gap between research progress and clinical readiness. In these stories, earlier CMC involvement might have saved resources and staved off delays.
- Developing Your Vapor Phase Hydrogen Peroxide Cycle
- Closing The Gap Between Modeling And GMP Predictive Control
- Exploring Earlier Gene Editing For Children With Dr. Haydar Frangoul, Part 1
- Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review
- Want More Sustainable Biopharma Packaging? Try These Levers
- What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI
- Fine-Tuning Bioseparation Column Geometry With 3D-Printed Monoliths
- How Is Your Glass Supplier Adapting To Europe's Energy Crisis?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Liquid Biopsy-Based Detection Of PIK3CA Mutations From cfDNA
Discover how ultra-sensitive digital PCR workflows use an innovative system to enable precise detection of rare PIK3CA mutations in cfDNA and advance personalized cancer treatment.
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Relieving Pressure During Preparation Of A High-Volume sNDA
Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.
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Reducing The Time And Cost Of Robust Analytical Method Development
Design-of-experiment methodology accelerates cell therapy assay development, reducing costs and timelines while improving assay robustness, regulatory readiness, and data-driven decision-making.
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Connected By Design: Laboratory Automation And Digital Transformation Strategy
Task-level automation delivers isolated gains, but the larger payoff in GxP laboratories comes from connecting instruments, systems, and data into workflows where samples move with minimal human handoffs.
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Streamlining Pediatric Clinical Trials With Vestigo®
Utilizing a centralized, automated platform can eliminate the friction of manual accountability logs, ensuring audit readiness while providing real-time visibility into financial reporting.
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Quantification Of Total mRNA Content In LNP Complexes
Learn how rapid, non-destructive techniques for mRNA quantification in LNPs can improve dosing accuracy, reduce variability, and accelerate decision-making for efficient scale-up and commercialization.
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Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation
Growing 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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Why The Traditional Approach To Evaluating Gene Editing Is Not Your Only Option
De-risk genetic medicine development with a phased evaluation approach. Gain rapid, data-driven feasibility insights before major investments, enabling smarter decisions and faster clinical progress.
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mRNA Manufacturing With Fed-Batch In Vitro Transcription
A milliliter-scale approach to IVT optimization reveals how controlled feeding, precise pH management, and real-time monitoring can boost mRNA yield and streamline scale-up to larger bioreactor volumes.
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Method Evaluation Guidance For Transferring A Process
Moving a cell counting method between analyzers in a lab requires evidence of comparability. A structured study of suspension and adherent models tests precision and linearity against defined criteria.
NEWSLETTER ARCHIVE
- 11.12.26 -- The Latest CDMO Opportunities And Threats Report
- 11.11.26 -- Exploring Earlier Gene Editing For Children With Dr. Haydar Frangoul
- 11.10.26 -- Implementing AI And Digital Twins In Bioprocessing With Will Olughu, Ph.D.
- 11.10.26 -- How To Stand Up A Hospital-Based CAR-T Manufacturing Network
- 11.09.26 -- Is Your Single-Use Process Built To Perform?
- What Will It Take To Turn CGT Innovation Into Market Success?
- Exploring Earlier Gene Editing For Children With Dr. Haydar Frangoul, Part 2
- Exploring Earlier Gene Editing For Children With Dr. Haydar Frangoul, Part 1
- Earlier Decisions, Better Processes Required For Automating Autologous CAR T Manufacturing
- Why In Vivo Innovation, Regulatory Convergence Will Help Shape CGT's Next Chapter
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
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