This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
- The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Selecting The Right eQMS To Maximize Quality Maturity
- How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
- FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
- Validating Candel's BLA-Ready Analytics Profile
- Mapping Candel Therapeutics' Sprint To The BLA Finish Line
- Why Cell And Gene Therapies Break After Early Success
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2155672333-2025-road-future-looking]( "Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends")
Future-Proofing Life Sciences Manufacturing: 2025 CDMO TrendsReview contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.
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![GettyImages-2174865889 lab, research]( "Quality Control Of Oligonucleotides Using HPLC Coupled To UV And MS Detection")
Quality Control Of Oligonucleotides Using HPLC Coupled To UV And MS DetectionEfficient quality control of therapeutic oligonucleotides is crucial. Explore advanced methods combining HPLC-UV and mass spectrometry for precise impurity quantification and mass confirmation.
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![GettyImages-2181934436-laboratory-analysis-scientists-technology-computer]( "Streamline Analytical Tech Transfer Through Analytical Target Profile")
Streamline Analytical Tech Transfer Through Analytical Target ProfileAnalytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.
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![Pharma Manufacturing GettyImages-1135140594]( "The State Of Digital Maturity In Pharma And Medtech Manufacturing")
The State Of Digital Maturity In Pharma And Medtech ManufacturingExplore results from a study aiming to understand why numerous companies continue to rely on manual, paper-based systems, and gain insight into how your competitors are gaining a competitive advantage.
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![GettyImages-1472832232 cleanroom]( "Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy")
Activate Advanced Contamination Control Technology To Safeguard Your Cell TherapyThe most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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![GettyImages-2152031133-atom-hand-gear-wrench-automation]( "Parallel Line Analysis And Relative Potency")
Parallel Line Analysis And Relative PotencyExplore parallelism testing methods, including response and parameter comparison tests, with innovative software to ensure accurate results with detailed protocols for linear and non-linear regression curves.
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![GettyImages-1327318287 cells]( "hiPSC Aggregate Expansion In Stirred-Tank Bioreactors")
hiPSC Aggregate Expansion In Stirred-Tank BioreactorsLearn about a bioreactor-based Human Induced Pluripotent Stem Cell (hiPSC) expansion workflow with the potential to improve cell therapy applications.
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![Research-Experiment-Trial-Discovery-GettyImages-1413606459]( "The Importance Of Quality Proteins For Research, Development, And Manufacturing")
The Importance Of Quality Proteins For Research, Development, And ManufacturingLearn how validated testing, strict sourcing, and regulatory guidance help minimize endotoxin contamination risks and support reliable therapeutic development in advanced medicinal products.
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![T-Cells Work to Fight Cancer, Immunotherapy, CAR T-cell therapy-GettyImages-1317697233]( "Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies")
Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T TherapiesDiscover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.
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![Pipette With Cell Culture Plate-GettyImages-520238063]( "Cytokines For Ex Vivo Cell Culture")
Cytokines For Ex Vivo Cell CultureComparable T cell expansion and function between cytokine sources were demonstrated. Generated CAR-T cells showed robust cytotoxicity and lower exhaustion markers.
NEWSLETTER ARCHIVE
- 05.01.26 -- New Podcast Episodes: Reprogramming T Cells, Radiotherapeutics, Rewriting Disease Biology
- 05.01.26 -- Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
- 04.30.26 -- Validating Candel's BLA-Ready Analytics Profile
- 04.29.26 -- Master pipetting, PCR, and NGS for cell and gene workflows.
- 04.29.26 -- Reprogramming T-Cell Access To Solid Tumors Via Improved Trafficking And Entry
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
- Mitigating Challenges In Solid Tumor Delivery
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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