Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
- Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need
- What Global Survey Says About Scant Patient Access To CAR-T Therapy
- Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
- Amgen Bets On Agility In The Age Of AI
- A Look At Elsa, The FDA's New AI Digital Assistant
- Navigating Data Management Requirements For Sterile Manufacturing
- The Promise Of Focused Ultrasound For AAV Gene Therapy Delivery
- A Guide To Designing mRNA Medicines
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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Mobile Clinical Lab For Miami Cancer Institute
Germfree helped the Miami Cancer Institute at the peak of the COVID pandemic convert a pharmacy compounding mobile unit to a BSL-2+ mobile clinical lab for in-house testing for COVID testing.
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Standardizing Cryopreservation For Cell Therapy Supply Chains
Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
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Achieving Optimal CAR-T Cell Generation
Discover the innovative methods behind CAR-T cell production, from custom plasmid design to lentiviral vector transduction, and explore their potential in revolutionizing cancer treatment.
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The Advantages Of A Blended Learning Approach In Operator Training
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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Accelerating The mAb Formulation Process
Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.
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Delivering Specialist Neurology Support
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
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AAV Vectors In Gene Therapy Clinical Trials
AAV-based gene therapies show promise but face immune challenges. ELISpot assays help evaluate T cell responses, enhancing clinical trial design and improving therapeutic success.
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A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived Exosomes
EV production scale increases require paired robust, scalable, and cost-effective downstream processes. Process parameters can be tailored for therapeutic exosome programs and allow for maximum exosome recovery.
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How Can I Increase My Viral Titers And Improve The Percentage Of Full AAVs?
Explore various strategies to enhance viral titer and increase the percentage of full AAV capsids, like modifications to transfection reagents, cell lines, media, procedures, and more.
NEWSLETTER ARCHIVE
- 06.20.25 -- Navigating CGT Biotech's Financial Headwinds And The Path Forward
- 06.19.25 -- Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
- 06.18.25 -- Choose The Fast Lane: Accelerate Your Viral Vector Manufacturing
- 06.18.25 -- Bridging Development And Regulation In CGT With Halloran Consulting Group's Monika Swietlicka
- 06.17.25 -- Your helping hand in filtration for high concentration drugs.

- The Promise Of Focused Ultrasound For AAV Gene Therapy Delivery
- Unlocking The Potential Of iPSC Therapies In Regenerative Medicine
- Ferring Builds A Global Gene Therapy Manufacturing Network Around ADSTILADRIN
- Atsena Therapeutics Advances Gene Therapy For XLRS
- Navigating CGT Biotech's Financial Headwinds And The Path Forward
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