The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Why A Cell Therapy CEO Waited Until Phase III To Outsource
- Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- How To Implement Post-Approval Changes On A Global Level
- March 2026 — CDMO Opportunities And Threats Report
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Tailoring Viral Clearance Study Design
Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
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Advanced Aseptic Filling Assembly Helium Integrity Testing
Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.
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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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When To Consider Material And Personnel Airlocks For Downflow Booths
Strategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.
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Cell Collection Basics For The Transplant And CGT Industries
Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.
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Biocompatibility Studies On CHO Cell Culture In X-ray Irradiated BioBLU® Single-Use Bioreactors
In cell culture, the leakage of toxic or inhibitory chemicals from single-use bioreactors has become a growing concern. Explore recommendations for leachable studies.
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Quantifying Lentiviral Physical Titer
Streamline lentiviral vector analytics with our direct RT-dPCR method. Achieve precise, reproducible results to accelerate safe, effective gene therapies with enhanced quality control.
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Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion
Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.
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Improved T Cell Expansion Using Closed, Automated Stirred-Tank Bioreactors
A shift from traditional rocking motion systems to stirred-tank bioreactors can enhance T cell expansion, offering greater scalability and more intimate process control.
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A Human-Relevant Model Of The Liver Sinusoid
This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
NEWSLETTER ARCHIVE
- 04.22.26 -- From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
- 04.21.26 -- All The Ways Global Biopharma Still Grapples With Annex 1
- 04.21.26 -- STREAM Edition: Bridging Analytical Gaps To Ensure CGT Material Quality
- 04.20.26 -- Why A Cell Therapy CEO Waited Until Phase III To Outsource
- 04.17.26 -- Large Molecule Capacity Powering Cell & Gene Therapies
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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