For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.
- Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic
- 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
- The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Set Your Cell And Gene Therapy Program Up For Success From Day One
Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
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Automation Of 3D Intestinal Organoids Culture
Gain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
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Don't Let Distribution Derail Your CGT Launch
Overcoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access.
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Automated Library Prep For A Nanopore DNA Barcoding Protocol
A streamlined workflow reduces reagent use and hands‑on time while preserving long‑read sequencing quality. See how multiplexed offer an efficient option for scaling or mobilizing sequencing efforts.
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Key Takeaways And Market Insights From The Inaugural ThinkLive Summit
The inaugural ThinkLive Cell and Gene Therapy Summit explored the industry’s dynamic landscape, highlighting collaboration, communication, and market access challenges.
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Key Selection Criteria For Cell & Gene Therapy CDMOs
Choosing the right CDMO requires early internal assessment plus strong technical capability, agility, advocacy, clear communication, and long‑term alignment to meet evolving cell and gene therapy needs.
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Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion
Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.
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Studying Gut Inflammation And Barrier Disruption With Organ-On-A-Chip Technology
See how the Colon Intestine-Chip has been employed to model cytokine-mediated inflammation and barrier disruption in the intestine.
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Scalability And Reproducibility Of The AAV9 Capture Step
Scaling gene therapies beyond rare diseases demands innovation. Discover a chromatography system that boosts efficiency, protects product integrity, and overcomes viral vector manufacturing challenges.
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Automated NGS Solutions Advance Rare Disease Research
See how a unified NGS workflow is helping a major pediatric genetics lab boost efficiency, manage growing sample volumes, and accelerate insights into rare diseases through streamlined automation.
NEWSLETTER ARCHIVE
- 03.17.26 -- Struggling with mAb aggregation and other impurities?
- 03.17.26 -- STREAM Edition: Building Smarter Cell Therapies With AI And Synthetic Biology
- 03.17.26 -- New MIT Consortium Links Innovation With Real-World Biomanufacturing
- 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
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.
More Content Collections