Determining whether a drug manufacturing environment is stable, drifting, or developing a recurring loss-of-control signal requires integrated trend evaluation.
- Fine-Tuning Bioseparation Column Geometry With 3D-Printed Monoliths
- How Is Your Glass Supplier Adapting To Europe's Energy Crisis?
- The EU Overhauls Pharma Laws: What You Need To Know
- Earlier Decisions, Better Processes Required For Automating Autologous CAR T Manufacturing
- Closing The CAR-T Access Gap With Hospital-Based Manufacturing
- How To Stand Up A Hospital-Based CAR-T Manufacturing Network
- September 2026 — CDMO Opportunities And Threats Report
- An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Translating Engineered AAV Capsids Into Manufacturable Gene Therapies
Engineered AAV capsids offer improved targeting and efficiency but introduce manufacturing, analytical, immunogenicity, and regulatory complexities requiring early, integrated development strategies.
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Navigating CMC Regulation For Plasmid DNA In Gene Therapy
Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
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Improving Formulation And Aliquoting Efficiency With Mixing Solutions
Separate formulation, filtration and aliquoting add transfers and integrity tests. A single closed flowpath can improve time, yield and contamination control.
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9 Logistics And Distribution Recommendations For CGTs
Cell and gene therapy commercialization requires tailored logistics strategies. Explore nine recommendations covering site readiness, reimbursement gaps, packaging, testing, and coordination.
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Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors
Progress in gene therapy manufacturing is being driven by improved cell line performance and scalable bioprocessing. See how high-density growth helps streamline development to larger-scale production.
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Automated Manufacturing Of CD34-Enriched Cell Products
See how this streamlined approach produces high-quality CD34+ cell products from cryopreserved apheresis material, integrating thawing, washing, and enrichment into a single automated workflow.
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Rapid Walkaway Solution For Assessing Viability In Cancer Organoids
Assess anti-cancer compounds' effects on organoid size and morphology with colorectal cancer organoids as well as discover automated imaging and viability assays to streamline drug screening and aid early identification.
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Phase 1 Clinical Trial Designs And Strategies
With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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Selecting A Central Lab Network For Radiopharmaceutical Readiness
A wave of late-stage radiopharmaceutical trials is straining lab infrastructure concentrated in a handful of academic centers, limiting site diversity, expertise, and trial capacity nationwide.
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A Human-Relevant Model Of The Liver Sinusoid
This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
NEWSLETTER ARCHIVE
- 11.06.26 -- Is Your Supply Chain Ready For The End Of Class VI?
- 11.05.26 -- Fixing High-Density Process Bottlenecks In Vector Production
- 11.05.26 -- Earlier Decisions, Better Processes Required For Automating Autologous CAR T Manufacturing
- 11.04.26 -- How The Right Media Boosts AAV Titer And Yield
- 11.04.26 -- Why In Vivo Innovation, Regulatory Convergence Will Help Shape CGT's Next Chapter
- Earlier Decisions, Better Processes Required For Automating Autologous CAR T Manufacturing
- Why In Vivo Innovation, Regulatory Convergence Will Help Shape CGT's Next Chapter
- Inside The Next Phase In Autoimmune CAR T From Meeting On The Mesa 2026
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- Inside Scaling Next-Gen MSCs Without Scaling Risk
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts
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