The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.
- CSV Assumes The AI System Sits Still — It Doesn't.
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- Combination Cell Therapy's Clinical Success Hinges On Manufacturability
- Are Biopharma Companies Outsourcing Their Ability To Think?
- June 2026 — CDMO Opportunities And Threats Report
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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How A QMS Embeds Quality Into Cell Therapy Production
Discover how a digital manufacturing solution helped a cellular therapy leader eliminate cleanroom paper, align quality teams, and accelerate batch release times by nearly 50%.
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Expansion Of Cord Blood-Derived CD34+ Cells In A Hollow-Fiber Bioreactor With 10% Standard Cytokine Concentration
CD34+ cells isolated from cord blood were expanded in a hollow-fiber bioreactor using a novel cytokine cocktail at one-tenth the standard concentration using a MSC-free coating strategy.
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Challenges, Methods, And Solutions For Obtaining Optimal Starting Material
For innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.
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Enhance Access And Improve Retention In Rare Disease Trials With HTS
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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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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Enabling MSC Harvest, Wash, And Concentration
A study demonstrates how a low-shear, closed-system centrifuge achieved over 90% MSC recovery and minimized viability loss, supporting scalable cell therapy manufacturing.
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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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Media Exchange In iPSC Cell Expansion And Differentiation: A Comparative Study
Low-shear, closed-system media exchange in iPSC differentiation is vital for scalability. This study compares automated centrifugation to gravity sedimentation, showing equivalent or superior differentiation outcomes.
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Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality
Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.
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End-To-End Clinical, Biometrics, And Regulatory Support In Neurology
Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.
NEWSLETTER ARCHIVE
- 08.18.26 -- The Missing Link Between AI Pilots And Production Success
- 08.18.26 -- Building Platform Strategies Instead Of One Off Vector Solutions
- 08.18.26 -- Reassessing Nanoparticle Immunotoxicity Testing Methods
- 08.17.26 -- June 2026 — CDMO Opportunities And Threats Report
- 08.14.26 -- The Fast Track to GMP Compliance
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- 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
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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