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-1185624320-scientist-lab-smiling]( "Leveraging Integrated Media Services For Speed And Efficiency")
Leveraging Integrated Media Services For Speed And EfficiencyUncertainty in media stability can limit efficiency and scalability in biologics manufacturing. See how a data-driven approach enables more predictable planning and reduces operational strain.
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![GettyImages-2183234647 AAV]( "Scale-Up Of AAV Production In Fixed-Bed Bioreactors")
Scale-Up Of AAV Production In Fixed-Bed BioreactorsConsistent AAV production is critical for manufacturing. See how aligned strategies deliver comparable cell growth, metabolic trends, and rAAV5 titers from development through production.
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![GettyImages-1297393276 Scientist using computer in lab]( "The Role Of Extractables Data In The Adoption Of Single-Use Systems")
The Role Of Extractables Data In The Adoption Of Single-Use SystemsExplore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
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![908 Devices - amino acid analysis]( "Amino Acid Analysis Indicates Metabolic Differences In MCB CAR T-Cells")
Amino Acid Analysis Indicates Metabolic Differences In MCB CAR T-CellsExploring the metabolic differences in CAR T-cells activated with multi-cytokine backpacks (MCBs) reveals correlations between CAR T-cell activation, nutrient metabolism, and efficacy.
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![GettyImages-2155418067-bioreactor-scientist-ipad-beaker]( "iPSC Aggregate Culture In Bioreactors Equipped With 8-Blade Impellers")
iPSC Aggregate Culture In Bioreactors Equipped With 8-Blade ImpellersControlled aggregation, oxygen management, and scalable workflows drive consistent iPSC expansion. Parallelized systems and precise parameter control improve reproducibility for faster optimization and confident transitions.
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![GettyImages-1336251027 IT Specialist Using Laptop Computer In Data Center]( "How We Used Intelligent Automation to Transform Vendor Selection")
How We Used Intelligent Automation to Transform Vendor SelectionDiscover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.
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![antibody molecules-GettyImages-2165626333]( "ADC Development Grows More Complex — SPR Insights Bring Clarity")
ADC Development Grows More Complex — SPR Insights Bring ClarityExplore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
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![GettyImages-171144953-cryopreservation-freeze]( "Small Volume ATMP Cryo-Freezing Strategies")
Small Volume ATMP Cryo-Freezing StrategiesDiscover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.
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![Lung disease treatment-GettyImages-1557382987]( "Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer")
Accelerating A Global, FIH ADC Therapy Trial For Lung CancerChoose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
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![GettyImages-1787595822-virus-viral-bacteria-cell]( "Application Of A Dual Spiking Strategy In Viral Clearance Studies")
Application Of A Dual Spiking Strategy In Viral Clearance StudiesExplore how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.
NEWSLETTER ARCHIVE
- 06.18.26 -- Scale Vaccine Production With Proven Cell Culture Solutions
- 06.18.26 -- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- 06.17.26 -- What's Slowing Your Cell & Gene Therapy Program?
- 06.17.26 -- Why Regulatory And Manufacturing Strategy Must Start Together
- 06.16.26 -- Reduce mAb Aggregates: Practical Strategies
- 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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