ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for agressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
- Pharmacogenomics In Oncology: A Pharmacokinetic Perspective
- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- Building A Self-Driving Lab For LNP Development
- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- Addressing The Particulate Challenge In Cell Therapy Products
- Let's Stop Treating Allogeneic Cell Therapy As One Thing
- Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1293879301-scientists-inspecting-analyzing-lab]( "Sample Clean-Up After N-Linked Glycan Release And Labeling")
Sample Clean-Up After N-Linked Glycan Release And LabelingGlycan profiling starts with effective clean-up. See how comparable recovery across key labeled glycans and sialylated glycan groups can support confident analysis while helping labs manage costs.
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![GettyImages-513110674 lab, research, sample, vial]( "Navigating CMC Regulation For Plasmid DNA In Gene Therapy")
Navigating CMC Regulation For Plasmid DNA In Gene TherapyExplore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
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![GettyImages-1390395748-cell-metabolism-glucose]( "In-Line Monitoring Of Culture Medium Using Live Cell Metabolic Analyzer")
In-Line Monitoring Of Culture Medium Using Live Cell Metabolic AnalyzerContinuous in-line monitoring of glucose and lactate levels provides highly accurate, real-time data on cellular metabolism without the risks or data gaps associated with manual periodic sampling.
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![Home Diabetes Treatment iStock-1127801655]( "Bringing Clinical Trials To Everyone's Backyard")
Bringing Clinical Trials To Everyone's BackyardLearn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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![GettyImages-1495393006 opthalmology, eye care]( "A Bright Future For Eye Care: The Advanced Therapy Revolution Is Here")
A Bright Future For Eye Care: The Advanced Therapy Revolution Is HereGroundbreaking cell and gene therapies are revolutionizing eye care. Discover how advanced treatments target root causes, offering unprecedented hope for conditions previously deemed untreatable.
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![Thermo Fisher - SUB DynaDrive]( "A Paradigm Shift From Glass Benchtop Bioreactors")
A Paradigm Shift From Glass Benchtop BioreactorsLearn how a bench-scale single-use bioreactor offers process development advantages over traditional glass systems, including higher efficiency, increased productivity, and enhanced sustainability.
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![GettyImages-1751659695-laboratory-scientists-computer-analysis-evaluation]( "CQA Assessment Of LNP-Encapsulated IVT mRNA")
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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![Corning - hyperstack]( "Expansion Of Human Bone Marrow-Derived MSCs")
Expansion Of Human Bone Marrow-Derived MSCsAchieving over 870 million viable, quality mesenchymal stem/stromal cells is possible. This efficient cell culture method scales bone marrow-derived MSCs for clinical needs.
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![HERMA - Form Fill Seal Applicator]( "Form Fill And Seal Label Applicator For Drug Packaging")
Form Fill And Seal Label Applicator For Drug PackagingDiscover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.
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![West-PO 3 - GCApp]( "Meeting Annex 1: A Proactive Approach To Regulatory Compliance")
Meeting Annex 1: A Proactive Approach To Regulatory ComplianceIt was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
NEWSLETTER ARCHIVE
- 07.28.26 -- STREAM Edition: Future CGT Manufacturing Trends, AI Reality Checks, And Phase 1 Strategy
- 07.28.26 -- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- 07.27.26 -- Building CGT Manufacturing Capacity For The Next Commercial Era
- 07.24.26 -- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- 07.23.26 -- CGT Biotech/CDMO Transparency & Core Capabilities
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
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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