FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- Active Versus Passive Shipping Solutions For Clinical Shipments
- January 2026 — CDMO Opportunities And Threats Report
- Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones
- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
- Why Clinical Supply Risk Starts With Demand Signals
- A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Factors Influencing CD34+ Cell Collection Efficiency In Leukapheresis
Efficiently collecting sufficient peripheral blood stem cells is paramount for successful transplantation, necessitating a deeper understanding of influencing factors and procedural nuances.
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Injection Site Reaction Screening Methodology
Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.
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Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
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The Rescue Option: Course Correcting Struggling Clinical Trials
The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.
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A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers
Explore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.
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Accelerate Cell Expansion And Sustain Viability With A Serum-Free Medium
Discover how Corning's Insect Cell serum-free medium outperforms other commercial media in yield, doubling time, and cell viability by diving into the study results.
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Functional Characterization Of 3D Assembled Neurospheres
Neural organoids and 3D spheroids offer advanced platforms for brain research and drug discovery. Discover how creating 3D neurospheres from iPSC-derived neurons and astrocytes aids in compound profiling and toxicity testing.
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Impact Of Media Selection
To highlight the importance of media selection, a study was conducted assessing the effect of three commercially available cGMP grade medias and their influence on T-cell phenotype.
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Challenges, Methods, And Solutions For Obtaining Optimal Starting Material
For innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.
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Optimizing TFF And SPTFF For High-Concentration mAb Formulations
Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.
NEWSLETTER ARCHIVE
- 02.23.26 -- Mastering EU GMP Annex 1: Packaging, Performance, And Contamination Control
- 02.23.26 -- Ready to design a scalable, cost optimized viral vector workflow?
- 02.23.26 -- Ensuring The Raw Material Data Package Supports Regulatory Filings
- 02.20.26 -- Deciding When Research Grade Raw Materials Are Sufficient
- 02.19.26 -- Advancing Your Cell and Gene Therapy Journey
- 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
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
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.
More Content Collections