Here's why strong material selection, risk-based controls, and early analytics are critical for successful CGT development.
- Generative AI Can Write The Code, But Who Builds In The Quality?
- From "Live Drug" To Precision Tool: Redefining CAR T Safety
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- February 2026 — CDMO Opportunities And Threats Report
- COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
- The Long Road To U.S. Vaccine Manufacturing
- Compliance, Costs, And Site Readiness In CAR-T Clinical Trials
- All The Ways Global Biopharma Still Grapples With Annex 1
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Advances In Analytical Method Selection And Technology Transfer
Successful analytical method transfer is crucial for product quality and regulatory compliance. Learn best practices for tech transfer, including how gap assessments mitigate common risks and streamline bioprocessing.
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Why Membrane Matters In AAV Filtration
Gene therapy is revolutionizing medicine to offer one-time treatments. Find out how AAV vectors are leading the way to optimize production and make these life-changing therapies accessible.
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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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A Better Immune Response To Vaccination: Using Lymphoid Follicle Organ-Chips
Discover a first-of-its-kind human LF-Chip containing B, T, plasma and antigen-presenting cells to test functional immunization responses to vaccines and adjuvants in vitro.
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Expanding Patient Access To Cell And Gene Therapies: Optimizing Channel Strategy
Rare disease innovation demands robust channel strategies for patient access. Learn how a patient-centric approach, logistical solutions, and strong partnerships are key to successful patient access.
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Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.
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Automated DNA Clean-Up Using Magnetic Bead-Based Methods
Discover how to improve DNA clean‑up through a precise magnetic bead–based workflow, as well as how optimized liquid handling enhances yield, purity, and reproducibility for higher confidence in results.
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Optimize T Cell Phenotype With One-Step Isolation And Activation
This comparative bench-scale study features active-release beads that could improve the reliability, consistency, and longevity of cell therapy treatments.
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Guiding Principles For Process Development And IND Readiness
Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.
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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
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- 03.25.26 -- Building Harmonized Real‑World Data In Oncology
- 03.24.26 -- STREAM Edition: AI-Designed Logic Circuits For Smarter Cancer Targeting
- 03.24.26 -- Delivery Strategy For Next-Gen Cardiac Gene Therapies
- 03.23.26 -- 5 QMS Blind Spots You Should Know About
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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