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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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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A Comparative Guide To CGTs: Modalities, Landscape, And Logistics
Cell and gene therapies (CGTs) have the potential to revolutionize medicine. However, achieving therapeutic success requires advanced logistical consideration to ensure product safety and efficacy
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Intuitive Bioprocess Scale-Up From Bench Scale To Pilot Scale
This study explores scaling a high-demand fed-batch process from bench to pilot scale, highlighting control parameter differences at 50L and 500L while maintaining consistent growth and product titers.
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Development Of LNP Formulations Using The KNAUER NanoScaler
Lipid nanoparticles (LNPs) offer a robust solution for nucleic acids. The NanoScaler system optimizes this technology, enabling scalable and reproducible LNP formulations for diverse applications.
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A Bright Future For Eye Care: The Advanced Therapy Revolution Is Here
Groundbreaking cell and gene therapies are revolutionizing eye care. Discover how advanced treatments target root causes, offering unprecedented hope for conditions previously deemed untreatable.
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Modern Lentiviral Platforms For Scalable Cell Therapy
A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.
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Mixing Of Various Dry Powdered Media And Buffers
Explore how this mixing system efficiently handles various powdered media and buffers, ensuring precise solubilization and mixing in applications like cell culture and protein purification.
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Optimized Performance Model For Yield And Quality Of The mRNA Product
Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
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Extractables In Single-Use Systems Used In ADC Manufacturing
To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.
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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.
NEWSLETTER ARCHIVE
- 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?
- 02.09.26 -- Strategies For Multi-Modal Success And Annex 1 Compliance
- 02.09.26 -- A Deeper Look At Pharma's Structural Supply Chain Vulnerability
- 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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