Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-157697835 lab, titer, research]( "Metabolic Phenotype Preservation And Suitability Of hMSCs Cultivated In Stirred Tank Bioreactors")
Metabolic Phenotype Preservation And Suitability Of hMSCs Cultivated In Stirred Tank BioreactorsLearn how researchers demonstrated scalable hADSC expansion in stirred-tank bioreactors using microcarriers, achieving metabolic stability and consistent growth for cell therapy applications.
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![GettyImages-2036497889-lab-computer-research]( "Smart Manufacturing: A Strategic Imperative For Pharma's Future")
Smart Manufacturing: A Strategic Imperative For Pharma's FuturePharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.
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![GettyImages-2190247072-laboratory-vials-analysis-scientist]( "Optimized Urine Liquid Biopsy Workflow")
Optimized Urine Liquid Biopsy WorkflowUrine-derived cell-free DNA is revolutionizing liquid biopsy research to offer a non-invasive, accessible tool for early disease detection, monitoring, and comprehensive diagnostics across oncology.
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![Genomic sequencing, molecular biology, and genetic data analysis-GettyImages-2153790378]( "Sample Quality Control In The Whole-Genome Sequencing Workflow")
Sample Quality Control In The Whole-Genome Sequencing WorkflowSee how consistent QC checkpoints show how even degraded samples can produce strong sequencing results when monitored with reliable sizing, quantification, and workflow‑specific thresholds.
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![dna, rna molecules-GettyImages-537327406]( "Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes")
Optimize DNA Clearance In High-Salt, GMP-Grade Purification ProcessesEfficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.
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![mRNA GettyImages-1356994684]( "Levers To Optimize The IVT Reaction For Increased mRNA Yield")
Levers To Optimize The IVT Reaction For Increased mRNA YieldMastering IVT yield requires balancing magnesium and nucleotide ratios. Learn how specific buffers and pyrophosphatase optimize mRNA synthesis for scalable, high-quality therapeutic production.
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![cell-gene-therapy-GettyImages-2157300524]( "21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?")
21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.
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![GettyImages-931069642 mAb, monoclonal antibodies]( "Empowering Antibody Discovery With ProSpeed™")
Empowering Antibody Discovery With ProSpeed™Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification of diverse therapeutic candidates.
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![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "The Key To Viral Vector Success")
The Key To Viral Vector SuccessEstablishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
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![SUS - ADC Filling]( "How Automated ADC Filling Cuts Labor By 90%")
How Automated ADC Filling Cuts Labor By 90%Manual ADC filling demands 30 labor hours per batch, introduces contamination risk, and leaves product recovery to chance.See how automation cut that to 2 hours with ROI in under a year.
NEWSLETTER ARCHIVE
- 06.30.26 -- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?
- 06.29.26 -- Simplify The Journey Of Advancing Your Therapies To Patients
- 06.29.26 -- May 2026 — CDMO Opportunities And Threats Report
- 06.26.26 -- Reimagining In Vivo Gene Editing Through Base Editing And Targeted Delivery
- 06.25.26 -- Fixing The Fragmentation In Outsourced Pharma
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- 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
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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