- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
- CGT Manufacturing Shifts From Capacity To Strategy
- Rethinking CQV In A Digital, Agile Manufacturing Landscape
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- The Next Frontier In Women's Cancer Care: Combining Cell Therapy With Immuno-Oncology
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Pre-Launch Checklist - A Roadmap To Success
The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.
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Advancing Dose Escalation Strategies With Bayesian Modeling
A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
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Analysis Of Partial Capsids Using Empty-Full Capsid Kit
Discover how to assess AAV genome integrity beyond ITR-2 using an extended ddPCR method for precise quantification of empty and full capsids with various genomic targets.
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Inside The Payer Perspective On Cell And Gene Therapy Coverage
Find out what 19 US payer organizations revealed about CGT coverage decisions, pre-approval engagement timelines, and the clinical evidence they need most to approve high-cost therapies.
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Redefining Biomanufacturing For Personalized Cancer Vaccines
Personalized cancer vaccines need fast, flexible manufacturing. Cell‑free synthetic DNA enables rapid, small‑batch mRNA production, supporting individualized therapies beyond plasmid‑based limits.
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Next Generation Sequencing In Viral Safety Testing
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
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Partner Case Study: Accelerating Gene Editing Manufacturing
Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.
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Automated Library Prep For A Nanopore DNA Barcoding Protocol
A streamlined workflow reduces reagent use and hands‑on time while preserving long‑read sequencing quality. See how multiplexed offer an efficient option for scaling or mobilizing sequencing efforts.
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NGS Analysis Of Hereditary Cancer Predispositions
Examine how a molecular genetics team improves NGS efficiency and library quality through streamlined automation, intuitive QC tools, and reliable workflows, boosting reproducibility.
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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.
NEWSLETTER ARCHIVE
- 05.28.26 -- Accelerate Your Assay And Imaging Data With These New Tools
- 05.28.26 -- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- 05.27.26 -- Smarter Processing For Workflows From Discovery To Commercial Scale
- 05.27.26 -- Rethinking Sterile Welding In Bioprocessing
- 05.27.26 -- Bridging Analytical Gaps To Ensure CGT Material Quality
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
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