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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Rapid Automated Selection Of Mammalian Cell Colonies
Discover how a new technology cultivates mammalian cells into clonal colonies and images them using fluorescent assays to isolate clonal cell populations based on surface protein expression.
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Finding An Optimal Harvest Solution By Considering Both Cost And Sustainability
Optimize your bioprocessing harvest with single-use centrifugation. Reduce costs, waste, and space needs compared to traditional depth filtration methods.
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Transforming PSP Enrollment To Enhance User Experiences And Optimize Workflows
Lengthy enrollment calls burden patients and PSP teams alike. See how a digital-first intake approach cut onboarding time and improved outcomes for everyone involved.
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Assessing The Success Of CRISPR Gene Therapies Using ddPCR Technology
Achieve high-fidelity results in gene therapy research. Discover how absolute quantification overcomes traditional limitations to provide the precision needed for validating CRISPR edits.
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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A Temperature-Stable Replacement For Animal Trypsin In Cell Dissociation Applications
Improve cell dissociation with a gentle, recombinant enzyme. This temperature-stable protease shows dissociation kinetics similar to porcine trypsin but with lower cell toxicity and greater overall purity.
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3D Neurospheres In Healthy And Alzheimer's: iPSC-Derived Neurons
Explore how different ApoE alleles influence Alzheimer's Disease risk using iPSC-derived neurons as well as gain insights into AD mechanisms and potential therapies.
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Enhance Access And Improve Retention In Rare Disease Trials With HTS
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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CAR Expression Detection Using Fluorescent Labeled Proteins, Flow Cytometry
Learn how site-specific fluorescent labeling addresses key challenges in flow cytometry-based evaluations by enhancing assay sensitivity, reducing variability, and ensuring reliable results.
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Expanding The Capabilities Of Targeted Integration
See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.
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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