Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- A QMS That Anticipates Cell And Gene Therapy Quality Challenges
- Using Digital Platforms To Find Your CDMO
- July 2026 — CDMO Opportunities And Threats Report
- ADC CDMO Selection For Small Biotech
- Implementing AI Solutions In GMP While Managing Risk
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up
Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.
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Monitoring Microbial Contamination Of Mammalian Cell Cultures
Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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Confident Sialic Acid Identification With MS/MS
Traditional mass spectrometry left uncertainty around potentially immunogenic glycans. Learn how a biologics developer achieved regulatory-ready clarity.
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End-To-End Workflow Integration For Antibody Development
Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.
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Best Practices For Analysis Of In Vitro Transcribed (IVT) mRNA
Learn best practices for high-resolution analysis of IVT RNA using automated capillary electrophoresis. Improve accuracy and precision in quantifying critical quality attributes.
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Commercial Success Starts With A Fit-For-Purpose Flow Cytometer
Discover how standardizing reagents and automating flow cytometry workflows can improve reproducibility, reduce troubleshooting, and accelerate progress in cell-based therapies.
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Engineering Challenges In Designing Pharmaceutical Isolators
Designing pharmaceutical barrier systems requires balancing strict cleanliness with practical engineering. Explore key factors for optimizing airflow and ergonomics.
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Synthetic DNA As An Alternative For Scalable Viral Vector Production
Enzymatically synthesized DNA is assessed as a plasmid alternative, showing comparable viral vector yield, quality, and purification, while improving scalability and regulatory flexibility.
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Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products
Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.
NEWSLETTER ARCHIVE
- 09.08.26 -- Choose New Analytical Technologies At The Right Stage Of Development
- 09.04.26 -- New Podcast Episodes: Fixing AAV Recovery, Cell Therapy Advances, Reimagining Solid Tumor Immunotherapy
- 09.04.26 -- The Blueprint For Viral Vector Manufacturing Success
- 09.04.26 -- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- 09.03.26 -- Real-Time Visibility Is Reshaping Outsourced Gene Therapy
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
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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