Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
- Inside ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive T-Cell Malignancies
- Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
- Pharmacogenomics In Oncology: A Pharmacokinetic Perspective
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2258800592-car-t-cell-therapy-manufacturing-3d]( "Memory T Cells – Depletion Of CD45RA+ Cells")
Memory T Cells – Depletion Of CD45RA+ CellsLearn how selective depletion of CD45RA-positive cells helps preserve pathogen-specific memory T cells, reduce potentially alloreactive populations, and support immune reconstitution strategies.
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![GettyImages-2190227882-male-scientist-lab]( "Automated Enrichment Of Human CD34+ Cells")
Automated Enrichment Of Human CD34+ CellsExplore an automated approach to CD34+ cell enrichment that combines scalable processing and high-purity cell recovery, offering insight into performance metrics and practical considerations.
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![Lab Experiment-GettyImages-157697835]( "Automated Enrichment Of Human CD34+ Cells")
Automated Enrichment Of Human CD34+ CellsDiscover an automated strategy for enriching CD34+ cells, combining streamlined processing, strong purity and viability metrics, and reduced hands-on effort to support stem cell engineering.
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![Tumor Cancer Cells-GettyImages-2203606213]( "Automated Tumor-Infiltrating Lymphocyte Expansion")
Automated Tumor-Infiltrating Lymphocyte ExpansionExamine how automated TIL manufacturing supports consistent expansion of viable, tumor-reactive lymphocytes across multiple cancer types and production sites, helping address key scalability challenges.
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![GettyImages-2178790629 cell]( "Ex-Vivo T Cell Depletion In Allogeneic HSCT")
Ex-Vivo T Cell Depletion In Allogeneic HSCTExplore a flexible cell depletion strategy that selectively removes targeted immune cell populations while preserving beneficial subsets, supporting tailored graft engineering approaches.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "Automated Manufacturing Of CD34-Enriched Cell Products")
Automated Manufacturing Of CD34-Enriched Cell ProductsSee how this streamlined approach produces high-quality CD34+ cell products from cryopreserved apheresis material, integrating thawing, washing, and enrichment into a single automated workflow.
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![cell-therapy-GettyImages-1494029118]( "Enrichment Of Human CD4+ And CD8+ Antigen-Specific T Cells")
Enrichment Of Human CD4+ And CD8+ Antigen-Specific T CellsA fully automated workflow streamlines cell processing, labeling, and magnetic separation. Learn how automation supports reproducible manufacturing of virus- and cancer-targeted cellular products.
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![GettyImages-1212712327 cell cultures]( "How Can I Increase My Viral Titers And Improve The Percentage Of Full AAVs?")
How Can I Increase My Viral Titers And Improve The Percentage Of Full AAVs?Explore various strategies to enhance viral titer and increase the percentage of full AAV capsids, like modifications to transfection reagents, cell lines, media, procedures, and more.
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![GettyImages-2190227882-male-scientist-lab]( "Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR Separation")
Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR SeparationADC characterization does not have to be overwhelmed by complex intact MS profiles. Smart column selection can improve separation, clarify critical quality attributes, and make ADC analysis easier.
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![cell-gene-therapy-GettyImages-2157300524]( "21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?")
21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us?Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.
NEWSLETTER ARCHIVE
- 07.31.26 -- Supply Chain Orchestration, Priorities For Smaller CGT Biotechs
- 07.30.26 -- Innovations To Support Scale And Efficiency In Your Process
- 07.30.26 -- Addressing The Particulate Challenge In Cell Therapy Products
- 07.29.26 -- Key Considerations for Combination Product Development
- 07.29.26 -- Full FDA Approval For TECELRA Is More Than A Regulatory Win For Solid Tumors
- 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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