Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- AI Has Arrived In Biotech CMC Amid Patchwork Governance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-481911027-mrna-3d-structure-dna-helix]( "mRNA Manufacturing With Fed-Batch In Vitro Transcription")
mRNA Manufacturing With Fed-Batch In Vitro TranscriptionA milliliter-scale approach to IVT optimization reveals how controlled feeding, precise pH management, and real-time monitoring can boost mRNA yield and streamline scale-up to larger bioreactor volumes.
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![Scientist Research Data GettyImages-1140779713]( "Simplified Workflow Using Automated Instrument Setup And Compensation On The BD FACSLyric™ Flow Cytometer")
Simplified Workflow Using Automated Instrument Setup And Compensation On The BD FACSLyric™ Flow CytometerExamine the usability and performance capabilities of a system that provides a streamlined flow cytometry workflow, from instrument initialization to data acquisition and analysis.
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![Viral Safety In Monoclonal Antibody Manufacturing-Getty-184714532]( "Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAs")
Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAsDiscover how Synthego's proprietary synthetic sgRNA, combined with Lonza’s 4D-Nucleofector®, enabled highly efficient gene editing in resting human CD4+ T cells.
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![chrom system app note pic]( "Scalability And Reproducibility Of The AAV9 Capture Step")
Scalability And Reproducibility Of The AAV9 Capture StepScaling gene therapies beyond rare diseases demands innovation. Discover a chromatography system that boosts efficiency, protects product integrity, and overcomes viral vector manufacturing challenges.
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![Organs-body-organoid-study-GettyImages-1157550305]( "A Study To Assess Organoid Size And Cell Count From 3D Image Analysis")
A Study To Assess Organoid Size And Cell Count From 3D Image AnalysisRecent advancements in 3D patient-derived organoids (PDOs) offer improved predictive power over traditional 2D assays. Explore a patented bioprocess for PDO expansion that could revolutionize drug discovery, especially in oncology.
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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids")
Streamline AAV-Based Gene Therapies With Off-The-Shelf PlasmidsStandardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.
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![GettyImages-673804426 aseptic biologics clean room lab]( "Solve ATMP Aseptic Filling Challenges With Gloveless Isolators")
Solve ATMP Aseptic Filling Challenges With Gloveless IsolatorsHuman intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.
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![Scientists In Lab Working Together On Digital Tablet GettyImages-893884830]( "The Complete Guide To Immunohistochemistry")
The Complete Guide To ImmunohistochemistryImmunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
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![Scientists working in lab-GettyImages-542935478]( "How Remote Pharmacy Monitoring Improves Trial Compliance")
How Remote Pharmacy Monitoring Improves Trial ComplianceExplore how leading IDS pharmacies are using remote monitoring workflows and digital accountability systems to improve accuracy, reduce site burden, and maintain audit readiness.
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![GettyImages-847137740 cell culture flask]( "Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance")
Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And ComplianceFragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.
NEWSLETTER ARCHIVE
- 06.17.26 -- Why Regulatory And Manufacturing Strategy Must Start Together
- 06.16.26 -- Reduce mAb Aggregates: Practical Strategies
- 06.16.26 -- STREAM Edition: When Should CGT Companies Keep Manufacturing In-House?
- 06.16.26 -- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- 06.15.26 -- Discover The Capabilities Driving Next-Generation Biologics
- 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
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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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