The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.
- 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?
- Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
- Is Your Supply Chain Ready For The End Of Class VI?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Advancing IHC Assays From RUO To Clinical Trials And CDx
Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.
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Forget About Isolators: Switching From Manual Vial To Automated Bag Filling
Discover how transitioning from manual vial filling to single-use bag systems can reduce contamination risk, improve accuracy, and enhance GMP compliance in biopharmaceutical manufacturing.
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End-To-End Clinical, Biometrics, And Regulatory Support In Neurology
Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.
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SaniSure Particulate Control Summary
Low particulate control requires more than cleanrooms. See how monitoring, process controls, inspections, and validated testing support quality and compliance.
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Studying The Spatial Architecture Of Glioblastoma
Explore how intra-tumor heterogeneity (ITH) impacts cancer progression and therapy resistance with advanced imaging platforms and custom antibody panels to reveal the spatial architecture of glioblastoma (GBM).
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Scale-Up Approaches For Culturing Adherent Cells
For successful scale-up, see how optimizing process parameters such as attachment methods, gassing, and agitation can help reduce cell environmental stress, ultimately improving productivity.
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Monitoring Of A pH Optimization Approach For CHO Cell Cultivation
Cloud-based monitoring and analytics help centralize data, gain real-time insight, and improve decision-making. Enhanced visibility and collaboration enable faster optimization and consistency across development and manufacturing.
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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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Liquid Biopsy-Based Detection Of PIK3CA Mutations From cfDNA
Discover how ultra-sensitive digital PCR workflows use an innovative system to enable precise detection of rare PIK3CA mutations in cfDNA and advance personalized cancer treatment.
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Transforming Clinical Trial Management
See how Vestigo® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.
NEWSLETTER ARCHIVE
- 11.03.26 -- Where Speed Is Lost: Fixing Handoffs In BioPharma Operations
- 11.03.26 -- How Manufacturing Changes Can Create Risk For MSCs
- 11.03.26 -- Advancing CGT Delivery, Regulatory Strategy With Axiom's Dr. Remo Moomiaie-Qajar
- 11.02.26 -- Why Human-Relevant Models Are Reshaping Early Drug Discovery
- 11.02.26 -- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- 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
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