Coordinating CAR-T trials means managing tight timelines, cryogenic handling, staffing gaps, and chain-of-identity risks where even small missteps can delay care.
- Where Contamination Control Really Breaks Down In Practice
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Scaling Of Impingement Jets Mixing For LNP Drug Production
Delve into the intricacies of Impingement Jets Mixing (IJM) technology and its pivotal role in the scalable and reproducible production of Lipid Nanoparticles (LNPs) for drug delivery.
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Virus Retention Performance Under Diverse Processing Conditions
Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.
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A Study To Assess Organoid Size And Cell Count From 3D Image Analysis
Recent advancements in 3D patient-derived organoids (PDOs) offer improved predictive power over traditional 2D assays. Explore a patented bioprocess for PDO expansion that could revolutionize drug discovery, especially in oncology.
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Tailoring Viral Clearance Study Design
Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
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Single-Use Technology And Environmental Responsibility In Biopharmaceuticals
Learn about strategies such as regional manufacturing and advanced single-use systems and their potential to minimize carbon footprint and enhance sustainable biomanufacturing.
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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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Accelerating Approval Pathway For Phase III Ovarian Cancer Trial
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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Reducing The Burden Of Patient Retention And Improving Continuity
Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
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Quality Control In IVT RNA Workflow
Accurate sizing and purity checks are essential in IVT RNA workflows. Explore how automated electrophoresis improves QC efficiency and ensures RNA integrity for downstream applications.
NEWSLETTER ARCHIVE
- 03.18.26 -- Advance Your MSC Process: New Research, Expert Talks, And Scaling Solutions
- 03.18.26 -- Proteomics Tools: A Resurrection
- 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
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