Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- In Vivo's Biggest Threat — Comparison To Old Models
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs
- Single-Use Standards Are Maturing, But The Process Remains King
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Smart Manufacturing: A Strategic Imperative For Pharma's Future
Pharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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End-To-End Workflow Integration For Antibody Development
Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.
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Relieving The Strain Of Publishing During Regulatory Registration
Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.
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Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation
Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.
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5 Essential Capabilities For Decentralized Clinical Trials
Learn how to develop and utilize a successful DCT framework, enabling your study to enhance patient access, improve data quality, and streamline study operations.
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Hepatitis B - Global Clinical Trial Landscape
As Hepatitis B virus (HBV) clinical trials advance, refining therapeutic endpoints and integrating novel treatment strategies are essential to transforming Hepatitis B management.
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How Can I Increase My Viral Titers And Improve The Percentage Of Full AAVs?
Explore various strategies to enhance viral titer and increase the percentage of full AAV capsids, like modifications to transfection reagents, cell lines, media, procedures, and more.
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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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Advances In Flow-Through Technology To Enhance mAb Polishing
Optimize your monoclonal antibody purification with cutting-edge flow-through chromatography. Learn how POROS resins enhance polishing efficiency, improve aggregate removal, and streamline bioprocessing.
NEWSLETTER ARCHIVE
- 02.06.26 -- New Podcast Episodes: Putting Pressure On CDMOs, BoB@JPM, Building Safer CRISPR Medicines For CVD
- 02.06.26 -- Sales & Operations Planning For Small Teams: Aligning Clinical Supply
- 02.05.26 -- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- 02.04.26 -- Balancing The Elements: Strategies For Resilient Clinical Research
- 02.04.26 -- In Vivo's Biggest Threat — Comparison To Old Models
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
- Global Shifts And Strategic Resilience Will Shape CGT In 2026
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
- CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B
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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