Tariffs, FDA workforce cuts, and a stalled BioSecure Act are reshaping CDMO strategy. Get the full policy breakdown to stress-test your supply chain planning now.
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
- Inside ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive T-Cell Malignancies
- Reshoring Pressure Meets Manufacturing Reality
- CDMO Live Europe 2026: Partnerships For An Uncertain World
- Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
- Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
- Pharmacogenomics In Oncology: A Pharmacokinetic Perspective
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Use Cation Exchange Chromatography For High Yields In Vaccine Production
Learn how to achieve high yields in vaccine production by using Cation Exchange Chromatography for purifying SARS-CoV-2 spike proteins. This method provides high purity and minimizes protein aggregates.
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Automation Of iPSC Culture, Passaging, And Expansion
Find out how iPSC-derived models enable researchers to generate diverse cell types and tissues as well as how automation reduces the labor-intensive culturing process with AI-powered decision-making.
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Measure And Control In-Line Protein Concentration
Streamline protein and antibody purification with an automated TFF system featuring real-time, in-line concentration measurement for enhanced accuracy, reliability, and cGMP compliance.
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Navigating The Cell And Gene Regulatory Landscape
Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.
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Building A Scalable Digital Foundation To Support CGT Manufacturing
Explore how digital systems strengthen CGT manufacturing by improving traceability and managing batch‑of‑one, as well as essential steps toward scalable, integrated operations.
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Integrated Upstream And Downstream Strategies For Robust Manufacturing
Process robust mAb production requires understanding scale dependent cell environments, leveraging predictive models, and pursuing data driven control to minimize variability and optimize quality.
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Why RWD Strategy Can't Wait With Price, Value And Evidence Pressures Everywhere
Overcome pricing pressures and reimbursement delays by integrating real-world evidence early in development to align clinical outcomes with payer demands and accelerate patient access.
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Flexible Multiplex Solution For VCN Determination In Gamma-Retrovirus–Transduced CAR-T Cells Using QIAcuity® dPCR
See how a multiplex digital PCR approach enables accurate, reproducible VCN determination in gamma‑retrovirus–transduced CAR‑T cells, supporting streamlined workflows and confident decision‑making.
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Preventive Control Of Sequencing Through The Insert
Understanding library size distributions helps prevent sequencing through the insert, reducing adapter read‑through. Explore how smear analysis guides optimal read‑length selection to avoid noise.
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How Remote Pharmacy Monitoring Improves Trial Compliance
Explore how leading IDS pharmacies are using remote monitoring workflows and digital accountability systems to improve accuracy, reduce site burden, and maintain audit readiness.
NEWSLETTER ARCHIVE
- 08.03.26 -- CGT Modality, Hybrid Models, And What To Keep In-House
- 07.31.26 -- Supply Chain Orchestration, Priorities For Smaller CGT Biotechs
- 07.30.26 -- Innovations To Support Scale And Efficiency In Your Process
- 07.30.26 -- Addressing The Particulate Challenge In Cell Therapy Products
- 07.29.26 -- Key Considerations for Combination Product Development
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
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.
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