Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
- Proteomics Tools: A Resurrection
- Powering AI And Synthetic Biology In Therapy Design
- Six Specialized Modalities Testing CDMO Readiness In 2026
- Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
- The Real Reason We Haven't Fully Automated Cell Therapy Yet
- Process Engineering's Key Role In Sterile Injectable Facility Design
- What To Know About — And How To Apply For — FDA's PreCheck Pilot
- Breaking Through Tumor Defenses With Next-Generation Cell Therapy
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Importance Of Quality In Raw Material Selection
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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Enhanced Development Of Virus-Specific Hybridomas
Double-stranded DNA viruses cause various human diseases, which complicates diagnosis due to antigen conservation. Explore a cell line that produces specific monoclonal antibodies to aid biotherapeutics development.
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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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Enabling Accelerated Raman Model Calibration For Real-Time Monitoring
Raman spectroscopy is a key component of a PAT strategy. Evaluate an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.
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Building A Scalable Digital Foundation To Support CGT Manufacturing
Explore how digital systems strengthen CGT manufacturing by improving traceability and managing batch‑of‑one, as well as essential steps toward scalable, integrated operations.
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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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The Proven, Practical Gateway To Upstream Process Intensification
N-1 perfusion enables higher inoculum densities, faster production, and reduced costs without altering fed-batch processes. Explore a practical path to intensification for biologics manufacturers.
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How Patient-Centric Approaches Are Shaping The Future Of CGT
Emily Whitehead’s CAR-T cell therapy journey highlights the power of patient engagement in cell and gene therapies. Discover how her story and advocacy drive a patient-centric approach in innovative treatments.
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Optimizing Performance For De-Risked Lentiviral Vector Production
Discover a de-risked, reproducible, and scalable platform for efficient GMP manufacturing of lentiviral vectors that maximizes titers and enriches recovery through upstream and downstream optimization.
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AAV Viral Titering Using Nanoplate-Based Digital PCR
Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.
NEWSLETTER ARCHIVE
- 03.06.26 -- New Podcast Episodes: Therapeutic Power Of Fibroblasts, Curative Cell Therapies, Breakthrough HER2 Immunotherapy
- 03.06.26 -- Simplifying Friction In Cell Therapy Clinical Trials With Dr. Panteli Theocharous
- 03.05.26 -- Regulatory, Payer & Distribution Insights For CGT Success
- 03.05.26 -- Process Engineering's Key Role In Sterile Injectable Facility Design
- 03.04.26 -- Breaking Through Tumor Defenses With Next-Generation Cell Therapy
- Powering AI And Synthetic Biology In Therapy Design
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- 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
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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