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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![injecting vaccine vaccination-GettyImages-665515600]( "Injection Site Reaction Screening Methodology")
Injection Site Reaction Screening MethodologyOptimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.
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![GettyImages-1457289257 patient]( "Quantitative ROI With DCTs")
Quantitative ROI With DCTsThrough dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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![GettyImages-1435391920-cell-culture-development-well-plate]( "Integrating Cutting-Edge Technologies In Cell Bank Manufacturing")
Integrating Cutting-Edge Technologies In Cell Bank ManufacturingDiscover how our adoption of a counterflow centrifuge enhances GMP-compliant cell banking through closed-system automation, precision harvesting, and scalable workflows.
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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.
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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-1348093614 mobile visit child]( "Redefining Accessibility For Pediatric Patients")
Redefining Accessibility For Pediatric PatientsExplore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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![GettyImages-1217285194 vials, test tubes, drug development]( "Lightning-Link<sup>®</sup> Conjugation Kits: Consistent Performance On A Broad Scale")
Lightning-Link® Conjugation Kits: Consistent Performance On A Broad ScaleLearn about labeling technology offering a transformative solution through direct antibody labeling without the need for post-conjugation purification, thereby mitigating antibody loss and ensuring reproducible results.
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![GettyImages-1914829121-rna-strands-molecule]( "Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines")
Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP VaccinesDiscover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
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![GettyImages-1166528597-scientist-lab-equipment-tubing]( "Automated PUPSIT For Drug Product Applications")
Automated PUPSIT For Drug Product ApplicationsAutomated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.
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![GettyImages-506999858-scientists-cell-culture-lab-development]( "NGS Analysis Of Hereditary Cancer Predispositions")
NGS Analysis Of Hereditary Cancer PredispositionsExamine how a molecular genetics team improves NGS efficiency and library quality through streamlined automation, intuitive QC tools, and reliable workflows, boosting reproducibility.
NEWSLETTER ARCHIVE
- 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
- 04.28.26 -- What FDA CRLs Reveal, USP <665> Countdown, Biowaiver Webinar
- 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.
More Content Collections
