A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.
- Is Your AI Model Trustworthy And Credible In GMP Processes?
- May 2026 — CDMO Opportunities And Threats Report
- In Vivo Gene Editing Is Moving From Promise To Proof
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1184711342-imaging-cancer-cells]( "Studying The Spatial Architecture Of Glioblastoma")
Studying The Spatial Architecture Of GlioblastomaExplore 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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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Separation Of cfDNA With An NGS Kit On Fragment Analyzer Systems")
Separation Of cfDNA With An NGS Kit On Fragment Analyzer SystemsLearn how precise sizing methods reveal nucleosome patterns in cfDNA and help distinguish true signal from extraction‑related artifacts for more reliable genomic analysis.
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![GettyImages-542712298-scientist-laboratory-equipment]( "Product Recovery Study For Fill Finish Applications")
Product Recovery Study For Fill Finish ApplicationsSurge bags are essential to fill finish efficiency, but poor drainage can cause costly product loss. Learn how drainage testing helps identify high-performance bags that maximize recovery and reduce waste.
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![sterile cleanroom protective gear]( "Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems")
Global Regulatory Harmonization: Comparisons In Aseptic Barrier SystemsCompare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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![Computer Science Research Laboratory with Robotic Arm Model-GettyImages-968289652]( "ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials")
ICH E6(R3) In Effect: Transforming Quality Management For CGT TrialsDiscover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.
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![GettyImages-1339300422 CAR T-Cell Immunotherapy]( "How To Successfully Isolate Your T Cells")
How To Successfully Isolate Your T CellsExplore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.
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![Bioreactor for cell culture-GettyImages-517653054]( "Chimeric Antigen Receptor Plasmid Production")
Chimeric Antigen Receptor Plasmid ProductionParallel single-use bioreactor setups enable faster optimization, improved reproducibility, and smoother transition from development to production—supporting more efficient and consistent cell therapy workflows.
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![GettyImages-2036497889-lab-computer-research]( "Transforming Clinical Trial Management")
Transforming Clinical Trial ManagementSee how Vestigo® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.
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![Hollow Fiber AAV App Note]( "Why Membrane Matters In AAV Filtration")
Why Membrane Matters In AAV FiltrationGene therapy is revolutionizing medicine to offer one-time treatments. Find out how AAV vectors are leading the way to optimize production and make these life-changing therapies accessible.
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![Researcher laboratory virus GettyImages-1212345443]( "Ensuring Viral Safety Through Multiplexed Adventitious Virus Detection")
Ensuring Viral Safety Through Multiplexed Adventitious Virus DetectionGain a targeted look at multiplex digital PCR that detects diverse human viral contaminants with speed, sensitivity, and precision. Learn how high‑multiplex workflows support QC needs.
NEWSLETTER ARCHIVE
- 06.23.26 -- STREAM Edition: Why In Vivo Therapies Are Moving Toward The Clinic With Ascidian Therapeutics' Dr. Mike Ehlers
- 06.23.26 -- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- 06.22.26 -- Navigating The Next Wave Of AAV Capsid
- 06.22.26 -- CDMO Selection: Start With The Relationship, Not The RFP
- 06.19.26 -- Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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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