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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Bio-Based Polymers Towards Net Zero In Single-Use BioprocessingDecarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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Flexible Multiplex Solution For VCN Determination In Gamma-Retrovirus–Transduced CAR-T Cells Using QIAcuity® dPCRSee how a multiplex digital PCR approach enables accurate, reproducible VCN determination in gamma‑retrovirus–transduced CAR‑T cells, supporting streamlined workflows and confident decision‑making.
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Background-Free Analysis Of Mouse TILsSyngeneic mouse tumor models are crucial for immunotherapy research, but variability in TILs and nonspecific binding complicate analysis. Discover how blocking reagents help but make the process more labor-intensive.
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Optimize DNA Clearance In High-Salt, GMP-Grade Purification ProcessesEfficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.
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Media And Buffer Mixing Using The Xcellerex™ Magnetic MixerA common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.
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Ready To Demystify Organoids?Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
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History Of Peptides In Medicine: From Early Chemistry To The GLP-1 EraPeptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug development.
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CQA Assessment Of LNP-Encapsulated IVT mRNALearn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.
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Transforming Clinical Trial ManagementSee how Vestigo® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.
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Seamless Process Transfer Using An In Silico Bioreactor Scaling ToolTransferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.
NEWSLETTER ARCHIVE
- 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
- 05.18.26 -- FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
- 05.15.26 -- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- 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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