Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![doctor patient health plan-GettyImages-1357807788]( "Why CGT Access Strategy Must Go Beyond Academic Medical Centers")
Why CGT Access Strategy Must Go Beyond Academic Medical CentersAcademic medical centers built the foundation for CGT delivery, but their reach has a ceiling. Closing the access gap means rethinking how these therapies move through community hospital networks at scale.
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![GettyImages-1472832232 cleanroom]( "Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy")
Activate Advanced Contamination Control Technology To Safeguard Your Cell TherapyThe most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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![GettyImages-2169909644-celll-meabolism-human]( "Novel Cardiotoxicity Evaluation Method Using iPS-Derived Cardiomyocytes")
Novel Cardiotoxicity Evaluation Method Using iPS-Derived CardiomyocytesDiscover how real-time monitoring of glucose and lactate in iPS-derived cardiomyocytes reveals subtle drug-induced metabolic shifts that traditional screening methods often fail to detect.
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![GettyImages-1435391920-cell-culture-development-well-plate]( "Seed Train Intensification Using High Cell Density Cryopreservation")
Seed Train Intensification Using High Cell Density CryopreservationStreamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.
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![West-Vials Glamour V9]( "Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations")
Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal CombinationsThe study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
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![GettyImages-1068302874-3d-cells-culture]( "3D Cell Culture Reveals Undetectable Drug Efficacy In Traditional Systems")
3D Cell Culture Reveals Undetectable Drug Efficacy In Traditional SystemsDrug discovery now targets cancer stem cells (CSCs) to achieve long-term tumor eradication, which moves beyond traditional chemotherapeutics. Discover an advanced screening platform that better predicts CSC inhibitor efficacy.
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![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "The Key To Viral Vector Success")
The Key To Viral Vector SuccessEstablishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
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![GettyImages-1309776439-scientists-lab-analysis-manufacturing]( "Optimized Transient Transfection Platform: AAV Program From Gene To GMP")
Optimized Transient Transfection Platform: AAV Program From Gene To GMPAchieve faster AAV gene therapy progress by adopting a unified platform for manufacturing. Accelerate your program to GMP readiness with up to 9x higher titers and robust, high-quality full capsid yields.
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![ai-data-GettyImages-2236890597]( "Unlock The Power Of Clinical Data Science")
Unlock The Power Of Clinical Data ScienceDiscover a unified, AI‑driven approach that helps clinical teams manage growing data complexity, accelerate insight generation, and improve trial oversight to enable faster decisions.
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![GettyImages-1068004492 women]( "Decentralized And Community-Based Solutions Driving Women's Healthcare")
Decentralized And Community-Based Solutions Driving Women's HealthcareClinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
NEWSLETTER ARCHIVE
- 07.08.26 -- Why In Vivo Therapies Are Moving Toward the Clinic with Ascidian Therapeutics' Dr. Mike Ehlers
- 07.07.26 -- Targeting Tau In Alzheimer's Disease With Voyager Therapeutics' Al Sandrock, M.D., Ph.D.
- 07.07.26 -- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- 07.06.26 -- In An Era Of Overcapacity, Should Companies Rent, Lease, Or Build Their Manufacturing Future?
- 07.03.26 -- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- 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
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
