FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- Why Contamination Control By Design Should Matter To Your CDMO
- Repeating Sanofi's Ballroom Design On Two Continents
- Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not
- Closing The MES Value Gap: Why Technology Isn't The Problem
- Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Can A Biotech Create A CDMO Market?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![scientist experimented in laboratory-GettyImages-909089478]( "Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing")
Comprehensive Pathway To Seamless Scale-Up Of mRNA DP ManufacturingAn integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.
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![GettyImages-2183234647 AAV]( "Scale-Up Of AAV Production In Fixed-Bed Bioreactors")
Scale-Up Of AAV Production In Fixed-Bed BioreactorsConsistent AAV production is critical for manufacturing. See how aligned strategies deliver comparable cell growth, metabolic trends, and rAAV5 titers from development through production.
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![GettyImages-1180581753-scientists-lab-monitoring-computer-laboratory]( "Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation System")
Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation SystemLearn how closed-system automation, combined with expert technical guidance and protocol optimization, turned a persistent manufacturing bottleneck into a reliable, scalable process.
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![Scientists working in lab-GettyImages-542935478]( "Cell Culture Media Mixing In A Benchtop Single-Use Mixer")
Cell Culture Media Mixing In A Benchtop Single-Use MixerExplore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.
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![GettyImages-1462147534 manufacturing]( "5 Steps To Design A Microbiological Performance Qualification For Facilities")
5 Steps To Design A Microbiological Performance Qualification For FacilitiesExplore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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![GettyImages-1388387927-computer-scans-brain-doctor-pen]( "Assessing Viability And Real-Time Apoptosis/Necrosis")
Assessing Viability And Real-Time Apoptosis/NecrosisMalignant gliomas are aggressive brain tumors that resist standard treatments. Discover why researchers focus on real-time cell death dynamics to develop targeted therapies and promising strategies.
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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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![Compliance Regulation Business Technology risk management-GettyImages-1433535736]( "Simplify CAPA In 7 Steps")
Simplify CAPA In 7 StepsDiscover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.
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![Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization]( "Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization")
Stabilization Of RNA-Loaded Lipid Nanoparticles By LyophilizationDiscover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
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![Eppendorf - CGT brochure]( "Tackling CGT Challenges: Stirred-Tank Bioreactors For R&D And Commercial Manufacturing")
Tackling CGT Challenges: Stirred-Tank Bioreactors For R&D And Commercial ManufacturingScalability remains a key bottleneck in CGT manufacturing. See how optimized stirred-tank bioreactor systems accelerate translation from clinical to commercial production.
NEWSLETTER ARCHIVE
- 05.20.26 -- Streamlined Lentiviral Characterization And QC With Digital PCR
- 05.20.26 -- Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
- 05.19.26 -- Building Integrated cGMP Systems For Autologous Cell Therapies With MassGen's Tatyana Matveeva, Ph.D.
- Cell And Gene Therapies: The Emerging Reality For Scalable Market Readiness
- 05.18.26 -- Strengthen Your Data Integrity and Safety
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
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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