Experts at PMWC 2026 emphasized that regulatory‑grade real‑world data in oncology will require prospectively collected, harmonized datasets that integrate multimodal clinical information.
- Trends In FDA FY 2025 Warning Letters
- SUS Interchangeability Assessment And Qualification Best Practices
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
- Accelerating Technology Diffusion In Cell And Gene Therapy
- The In Vivo Cell Therapy Shift On Display At PMWC 2026
- Inside SynaptixBio's Mission To Develop A Therapy For H-ABC
- 5 QMS Blind Spots You Should Know About
- New MIT Consortium Links Innovation With Real-World Biomanufacturing
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Engineering Reliability In Cell Therapy Manufacturing
A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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Balancing Protein A Resin Cost, Performance, And Productivity
Optimizing input parameters like DBC, flow rate, and resin durability is key to boosting productivity in downstream bioprocessing. Discover how to tailor resin choices to meet your specific process requirements.
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Improving Gene Therapy Development With Organ-On-A-Chip Technology
Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.
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Expansion Of Human Umbilical Cord-Derived MSCs
Discover how high-quality, multipotent stromal cells are efficiently produced for regenerative medicine. Learn about their impressive viability and critical marker expression for therapeutic uses.
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Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool
Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.
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Protect Your Columns And Your Peaks
Learn how thoughtful filter selection can protect LC systems, improve protein recovery, and support reliable chromatographic results with key performance data and solvent compatibility insights.
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Tailored Approach Supports Bladder Cancer Breakthrough
Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.
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Screening Peptones, Including "Titration And Blending" Protocol Examples
Dive into the importance of peptone selection, instructions for reconstituting peptone powders for mammalian cell culture, and discover starter packs containing commonly used peptones for specific applications.
NEWSLETTER ARCHIVE
- 03.16.26 -- From Discovery To AAV Production: Tools To Accelerate Gene Therapy
- 03.16.26 -- Not So Fast Into The Night: Your Outsourcing Needs A Pause
- 03.14.26 -- Cell & Gene Best Of February
- 03.13.26 -- Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
- 03.12.26 -- Six Specialized Modalities Testing CDMO Readiness In 2026
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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