Clinical supply risk often begins long before manufacturing or distribution. Flawed demand signals and enrollment forecasts can quietly create shortages, delays, and costly material waste.
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- In Vivo's Biggest Threat — Comparison To Old Models
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs
- Single-Use Standards Are Maturing, But The Process Remains King
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Remote Patient Monitoring Using Mobile Health Technology
This study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.
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Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis
This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.
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Multiplex Imaging
Explore recombinant antibody reagents that support the imaging of key targets within the TME and offer flexible solutions across various platforms to improve patient outcomes.
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Performance Comparison Of The Vericheck ddPCR™ Empty-Full Capsid Kit And Analytical Ultracentrifugation (AUC)
Discover how Droplet Digital PCR (ddPCR) offers a precise analysis of AAV capsid content, outperforming analytical ultracentrifugation (AUC) in distinguishing therapeutic genomes from contaminants.
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A Comparative Study Of Cryopreservation Media
This study compared two different cryopreservation mediums and the data highlights which is ideal for preserving the viability of different cell types, including Mesenchymal Stem and HEK-293 Cell Line.
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Best Practices For Regulatory Excellence In Clinical Research
Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.
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Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Molecular Approaches To Streamline Cell Therapy Product Analytical Testing
Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.
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Next Generation Sequencing In Viral Safety Testing
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
NEWSLETTER ARCHIVE
- 02.05.26 -- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- 02.04.26 -- Balancing The Elements: Strategies For Resilient Clinical Research
- 02.04.26 -- In Vivo's Biggest Threat — Comparison To Old Models
- 02.03.26 -- STREAM Edition: Data Governance And Regulations For AI Use In GMP With Peter Baker
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
- Global Shifts And Strategic Resilience Will Shape CGT In 2026
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
- CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B
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