Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.
- May 2026 — CDMO Opportunities And Threats Report
- In Vivo Gene Editing Is Moving From Promise To Proof
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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384-Well Microplate Time Resolved Fluorescence (TRF) Immunoassay
Examine how innovative sandwich ELISAs in a 384-well format can be utilized with a sensitive reader for high-throughput screening to quantify Human IgG and IFN gamma.
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Decentralized And Community-Based Solutions Driving Women's Healthcare
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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How Blast Freezing Affects The Quality Of Bottled Drug Substance: Test Results And Insights
Uneven ice formation during bottle freezing creates a "Volcano Effect," pushing solutes into highly concentrated zones. This test-based study explains this risk to drug substance quality.
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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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Manufacturing Strategies To Industrialize Autologous Therapies
Discover how a systematic approach to autologous cell therapy manufacturing can reduce costs, improve reliability, and accelerate access to life-changing treatments.
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Analytical Method Release And Stability Platform For RNA Drug Substance
We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
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Delivering Specialist Neurology Support
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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Cytokines For Ex Vivo Cell Culture
Comparable T cell expansion and function between cytokine sources were demonstrated. Generated CAR-T cells showed robust cytotoxicity and lower exhaustion markers.
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AAV Viral Titering Using Nanoplate-Based Digital PCR
Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.
NEWSLETTER ARCHIVE
- 06.19.26 -- Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- 06.18.26 -- Tools And Technologies Enabling Next-Generation Cell Therapies
- 06.18.26 -- Scale Vaccine Production With Proven Cell Culture Solutions
- 06.18.26 -- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- 06.17.26 -- What's Slowing Your Cell & Gene Therapy Program?
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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