Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- Building A Self-Driving Lab For LNP Development
- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- Addressing The Particulate Challenge In Cell Therapy Products
- Let's Stop Treating Allogeneic Cell Therapy As One Thing
- Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Control Strategies And Method Development For Nitrosamines In APIs And Drug ProductsExplore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.
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NGS Analysis Of Hereditary Cancer PredispositionsExamine how a molecular genetics team improves NGS efficiency and library quality through streamlined automation, intuitive QC tools, and reliable workflows, boosting reproducibility.
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Navigating Project Optimus And The Rapidly Changing Oncology Development LandscapeProject Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
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Solutions For CQA Analysis Of IVT mRNA-Based BiotherapeuticsDiscover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows, including advanced technologies and methodologies to optimize your research and development processes.
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12.5x Titer Boost Accelerates CAR-T Program To IND FilingPlasmid engineering and process development boosted viral titer 12.5×, eliminating manufacturing bottlenecks and enabling an on‑time regulatory submission for the cell therapy program.
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CRISPR Reagents Enable High Efficiencies Of Editing And HDR In iPSCsAchieving consistent Homology Directed Repair (HDR) in iPSCs requires optimized CRISPR design and workflows. See how advanced reagents and targeted enhancement strategies improve insertion efficiency.
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Addressing A Critical Drug ShortageA critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.
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Relieving The Strain Of Publishing During Regulatory RegistrationGo inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.
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NEWSLETTER ARCHIVE
- 07.23.26 -- CGT Biotech/CDMO Transparency & Core Capabilities
- 07.22.26 -- Accelerate Your Gene Therapy Pipeline with NGS, AAV Clearance, and Virus Bank Expertise
- 07.22.26 -- Wondering If Your Org Should Purchase R&D Datasets?
- 07.21.26 -- How To Match CGT Manufacturing Models To Pipeline Needs
- 07.21.26 -- Exploring Dendritic Cell Therapy for Solid Tumors With Diakonos Oncology's Jay Hartenbach
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
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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