At the 2026 @Philly Cell and Gene Therapy Annual Conference, Dr. Peter Marks highlighted how gene therapy science is surging ahead and called for smarter regulatory evolution to unlock treatments for thousands of rare disease patients.
- April 2026 — CDMO Opportunities And Threats Report
- Cell And Gene Therapies: The Emerging Reality For Scalable Market Readiness
- Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
- Why Your MES RFP Is Failing Before It Starts
- Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
- Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction
- Inside March Biosciences' CD5-Targeting CAR-T Approach
- Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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AAV Viral Titering Using Nanoplate-Based Digital PCR
Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.
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Product Recovery Study For Fill Finish Applications
Surge bags are essential to fill finish efficiency, but poor drainage can cause costly product loss. Learn how drainage testing helps identify high-performance bags that maximize recovery and reduce waste.
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Maintain Sterility And Ease In CGT Development, Including Cryopreservation
Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.
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Standardizing Cryopreservation For Cell Therapy Supply Chains
Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
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Smart Scaling For Cell And Gene Therapies
To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
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Immuno-Oncology Biomarker Measurement With High Sensitivity And Speed
Explore results demonstrating the successful use of innovative ELISA assays to detect three key biomarkers: Programmed Death Ligand 1 (PD-L1), Interleukin-8 (IL-8), and Interferon Gamma (IFN-γ).
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Unraveling The Complexity Of Cell Therapy: Advancements And Challenges
Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.
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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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Ensuring Product Safety And Purity With Mycoplasma And Sterility Testing
Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.
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What FDA CRLs Reveal About CCIT
FDA rejection letters show common CCIT gaps — low sensitivity and incomplete validation. Spotting these trends helps teams strengthen integrity testing and avoid approval delays.
NEWSLETTER ARCHIVE
- 05.13.26 -- Rewriting Disease Biology Through LSD1 Inhibition
- 05.12.26 -- West Vantage: End-to-End Combination Product Solutions
- 05.12.26 -- STREAM Edition: Inside The Phased, Risk-Based Approach For CGT Materials
- 05.12.26 -- Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction
- 05.11.26 -- Optimize Your Lab Workflows And MSC Expansion
- 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
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
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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