For the next-generation cell and gene therapies, we must rethink design and controls, and we must reframe the problem from modality to architecture.
- A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Determination Of Immune Cell Composition And CAR-T Cells
Discover a system that automates CAR-T cell production using flow cytometry and analyzers for precise monitoring as well as learn about the sample preparation, instrument setup, and data analysis.
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Lentiviral Vector Bioproduction Follow-Up Tool
Explore a new optical device that performs real-time, user-friendly, and label-free measurements of lentiviral vector physical titer and size distribution.
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Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing
Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.
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Advancing An Integrated Biopharma Workflow Strategy
Global research teams were generating critical data in disconnected systems, hindering collaboration. Explore how unified workflows and a shared data backbone strengthen efficiency.
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Leveraging Droplet Digital PCR For Accurate Viral Titer Measurement
Accurately measuring viral titer is a key metric throughout gene therapy development, whether you are in the early stage, scaling production, or running assays for quality control release.
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Automated Library Prep For Nanopore Human Whole Genome Sequencing
Gain insight into an automated high‑input workflow that streamlines long‑read whole‑genome library prep, supporting large DNA fragments while reducing reagent use.
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ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
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Efficient Late-Stage Development Of Biologics
Reducing biologics manufacturing costs requires strategic late-stage process development, yield optimization, scale-up, and raw material substitution—all while maintaining product quality and regulatory compliance.
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Alternative Two-Step Mixed-Mode Approach To A mAb Purification Process
Two post–Protein A capture two-step mAb processes were developed and compared to an archetypical three-step mAb purification process using two IEX steps after Protein A capture.
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Predicting Antibody-Dependent Cell-Mediated Cytotoxicity
We developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.
NEWSLETTER ARCHIVE
- 02.11.26 -- Breakthroughs In Cell Research & Automation
- 02.11.26 -- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- 02.10.26 -- The Future Of Pharma Manufacturing Starts With Digitalization
- 02.10.26 -- STREAM Edition: 2026 Regulatory Roadmap: Get Set Up For Success
- 02.10.26 -- Which Advanced Modalities Are Built For Commercial Scale In 2026?
- 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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