Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.
- 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
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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A Beginner's Guide To Sf9 Culture In Stirred-Tank Bioreactors
Learn about the workflow steps for Sf9 cell expansion, virus preparation, and protein production in stirred-tank bioreactors, including GFP expression.
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Techniques For PEGylation Site Identification
Examine how our innovative methods enable the precise identification of PEGylation sites, unlocking deeper insights into the structure, stability, and function of biotherapeutics.
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Accelerating Clinical Data Review With Traceable Workflows
Clinical data review needs centralized access and traceable workflows. Leveraging AI-automation and real-time collaboration drives faster, better-informed decisions and reduced compliance risk.
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Development And Optimization Of LNP Formulations
The production of lipid nanoparticles (LNPs) is a process that demands robustness, scalability, and reproducibility. Examine the impact of key operational parameters on the efficacy of LNPs.
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5 Must-Haves For Electronic Batch Records In Life Sciences
Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.
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Enhanced Development Of Virus-Specific Hybridomas
Double-stranded DNA viruses cause various human diseases, which complicates diagnosis due to antigen conservation. Explore a cell line that produces specific monoclonal antibodies to aid biotherapeutics development.
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Analysis Of DNA Integrity And Stability Using Digital PCR
Digital PCR offers precise, inhibitor-resistant DNA quantification and genome integrity assessment. Discover how this method enhances accuracy and reproducibility, especially in AAV analysis, using multiplexed targets and Poisson-based calculations.
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Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance
Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.
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What FDA CRLs Reveal About CCIT
FDA rejection letters show common CCIT gaps — low sensitivity and incomplete validation. Spotting these trends helps teams strengthen integrity testing and avoid approval delays.
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High-Throughput IgG Quantification Assay For Cell Line Development
Monoclonal antibodies are revolutionizing treatment for various diseases, which include cancer and autoimmune disorders. Discover how improving production methods can reduce costs and enhance accessibility.
NEWSLETTER ARCHIVE
- 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
- 04.28.26 -- Target Selection Drives The Future Of CAR-T Therapy In Solid Tumors
- 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
- Ensuring Quality Of CGT Materials
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