Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
- ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive 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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Addressing A Critical Drug Shortage
A critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.
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Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success
The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.
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Essential Strategies For Effective Viral Clearance Studies In Biologics Manufacturing
Strengthen your viral safety strategy by applying science- and risk-based approaches to viral clearance planning, ensuring robust data, regulatory compliance, and patient protection.
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ADC Manufacturing: Practices, Challenges, And The Road Ahead
ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.
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Business Continuity Management: The Benzonase® Endonuclease Success Story
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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Bispecific T- Cell Engager (BiTE) Screening, Automated Pipeline
View automated, high‑throughput BiTE screening in mammalian cells, enabling rapid discovery of efficacious variants through precise genomic integration and scalable workflows.
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End-To-End Process Scalability Of HEK 293 Media For High Titer AAV Production
Explore how controlled bioreactor environments enable optimization of critical process parameters and support robust, scalable AAV production from development through manufacturing.
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Automated DNA Size Selection For Flexible NGS Workflow Integration
Gain insight into automating DNA size selection that shows how optimized bead ratios and programmable handling improve fragment recovery, consistency, and throughput.
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Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations
The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
NEWSLETTER ARCHIVE
- 08.05.26 -- Advancing Precision In Clinical Trial Design
- 08.05.26 -- How Precision Oncology Is Redefining Cancer Drug Development With Aprea Therapeutics' Dr. Oren Gilad
- 08.04.26 -- De-Risk MSC Development From Source To Scale
- 08.04.26 -- STREAM Edition: When Great Biology Meets Manufacturing Reality
- 08.03.26 -- CGT Modality, Hybrid Models, And What To Keep In-House
- 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.
More Content Collections