The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
- 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
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Role Of Peptones In Boosting Monoclonal Antibody Production
Peptones have become a key tool in CHO cell bioprocessing, enhancing monoclonal antibody yield and quality.
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Chimeric Antigen Receptor Plasmid Production
Parallel single-use bioreactor setups enable faster optimization, improved reproducibility, and smoother transition from development to production—supporting more efficient and consistent cell therapy workflows.
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Vial Adapter Transfer Device Compatibility With Cell Therapies
Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
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Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids
Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.
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Simpler, Faster, Cheaper Advanced Therapy Manufacturing
Discover how TFDF-based perfusion technology boosts lentiviral vector production by over 10-fold, slashes costs, and accelerates the commercialization of CAR-T and other advanced cell therapies.
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Navigating CMC Regulation For Plasmid DNA In Gene Therapy
Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
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Monitoring Microbial Contamination Of Mammalian Cell Cultures
Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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Lightning-Link® Conjugation Kits: Consistent Performance On A Broad Scale
Learn about labeling technology offering a transformative solution through direct antibody labeling without the need for post-conjugation purification, thereby mitigating antibody loss and ensuring reproducible results.
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Delivering Critical Therapies With Speed And Safety
Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.
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Enhancing AAV Production Performance And Economics
Enzymatically produced dbDNA offers safer, faster, and more scalable AAV manufacturing by reducing costs, improving full capsid yields, and enabling high‑fidelity, bacteria‑free DNA production.
NEWSLETTER ARCHIVE
- 08.17.26 -- June 2026 — CDMO Opportunities And Threats Report
- 08.14.26 -- The Fast Track to GMP Compliance
- 08.14.26 -- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- 08.13.26 -- New Resources: MSC Manufacturing, Expansion, and Scale-Up Technologies
- 08.13.26 -- Building A Self-Driving Lab For LNP Development
- 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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