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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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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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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Automation Of 3D Intestinal Organoids Culture
Gain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
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Highly Efficient Production Of Adeno-Associated Virus
This study evaluates the performance of a flexible, automated fixed bed reactor (FBR) system during AAV production, comparing it with a similar FBR system and 2D cell culture controls.
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A Better Immune Response To Vaccination: Using Lymphoid Follicle Organ-Chips
Discover a first-of-its-kind human LF-Chip containing B, T, plasma and antigen-presenting cells to test functional immunization responses to vaccines and adjuvants in vitro.
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Cell Culture Media Mixing In A Benchtop Single-Use Mixer
Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.
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Controlled Production Of MSC-Derived EVs In Stirred-Tank Bioreactors
Learn how stirred-tank bioreactors overcome the scalability limitations of static culture for MSC-EV production, while Raman spectroscopy provides unprecedented real-time quality monitoring during production.
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A Human-Relevant Model Of The Liver Sinusoid
This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
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Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization
Discover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
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Background-Free Analysis Of Mouse TILs
Syngeneic mouse tumor models are crucial for immunotherapy research, but variability in TILs and nonspecific binding complicate analysis. Discover how blocking reagents help but make the process more labor-intensive.
NEWSLETTER ARCHIVE
- 03.09.26 -- Putting Pressure On CDMOs With Herman Bozenhardt
- 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
- 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.
More Content Collections