True scalability and global-ready CGT manufacturing depends on platformization that tightly integrates MES, ERP, LIMS, and related systems into a harmonized, leadership-driven digital backbone that treats data as a strategic asset.
- Navigating The Challenges Of Cell Therapy Clinical Trials
- Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up
- Strained Manufacturing, Complexity Stymie In Vivo Progress
- To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
- Could Chicken Wisdom Help Cell Therapies Spread Wings?
- Formulation And Delivery Considerations For Cell And Gene Therapies
- The Promise And Paradox Of QbD
- The Future Of Biotech Outsourcing: Essential Skills For Program Managers
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Review Of Applications And Processes In Fixed-Bed Bioreactors
Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.
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Optimizing Human iPSC Aggregate And Organoid Production For Bioprinting
This study aimed to identify the optimal cell culture conditions to yield high cell density and maintain high cell viability with consistent aggregate morphology and pluripotency marker expression.
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Targeted Indication Selection Using Adaptive Design
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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A New Way To Perform mAb Capture
Combining high-productivity chromatography methods and SU affinity membranes delivers a viable alternative to the current packed bed Protein A capture techniques for intensified purification of mAbs.
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Supporting A CAR T-Cell Therapy Study In Hematologic Malignancies
To address a life-threatening complication of immunotherapy in hematologic malignancies, a U.S. biotech company developed a novel compound.
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Comparing Serum-free To Serum-Supplemented Media
Reducing serum in vaccine manufacturing is a key consideration for lowering costs and improving supply security. We compare performance in serum-free versus serum-supplemented media.
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Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
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Accelerate Process Development With Automated Aseptic Sampling
Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.
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Manufacturing Challenges With High Concentration Biologics
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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Comparing In-Line Vs At-Line Variable Pathlength Tech For UF/DF
Discover how rapid amino acid profiling improves media insight, detects variability, and supports real-time optimization for stronger bioprocess control, as well as strategies to reduce risk.
NEWSLETTER ARCHIVE
- 12.11.25 -- High-Quality Vectors: Optimized AAV, mRNA Manufacturing, And 3D dPCR Analysis
- 12.11.25 -- Your Expert Guide To Perfusion And Process Intensification
- 12.11.25 -- Formulation And Delivery Considerations For Cell And Gene Therapies
- 12.10.25 -- Global Trials And Oncology Insights
- 12.10.25 -- Advancing Hematology And Cell Therapy Innovation
- Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional
- Why Early Manufacturing Decisions in Cell & Gene Therapy Matter
- How Early Manufacturing Decisions Shape Long-Term Success
- Understanding CLL And SLL Treatment Evolution
- Advancing Telomere Targeting Therapy For Non-Small Cell Lung Cancer
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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