By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Building Sustainable Biopharma Supply Chains Starts With Procurement
- Sustainable Facility Design Brings Bayer Instant Savings
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- Why You Should Measure Comparability Debt Before Ever Starting A Study
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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Process Intensification And Other Ways To Adapt To Changing Needs
As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.
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Enhancing Preclinical Cell Therapy Development
Automation in cell therapy development boosts reproducibility, reduces error, and enhances yield. Learn how it’s reshaping preclinical workflows and accelerating clinical trial readiness.
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21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?
Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.
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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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Automated Manufacturing Of CD34-Enriched Cell Products
See how this streamlined approach produces high-quality CD34+ cell products from cryopreserved apheresis material, integrating thawing, washing, and enrichment into a single automated workflow.
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Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges
Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.
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A Beginner's Guide To Mesenchymal Stem Cell Culture
Gain a foundational understanding of the process for culturing mesenchymal stem cells in stirred-tank bioreactors and learn about the key parameters for successful scale-up.
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Can Your Biopharma Team Keep Unplanned Downtime At Bay?
Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.
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Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity
A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.
NEWSLETTER ARCHIVE
- 10.05.26 -- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- 10.02.26 -- Building Sustainable Biopharma Supply Chains Starts With Procurement
- 10.01.26 -- New Podcast Episodes: 2026 Regulatory Updates, Funding A Virtual Biotech, Structuring CGT Deals
- 10.01.26 -- Building An End-To-End Strategy For CGT Manufacturing
- 10.01.26 -- Why CDMO Capacity Investments Signal A New Era In Cell & Gene
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
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