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.
- Building Sustainable Biopharma Supply Chains Starts With Procurement
- Sustainable Facility Design Brings Bayer Instant Savings
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- Why You Should Measure Comparability Debt Before Ever Starting A Study
- What FDA Inspectors Want From Your OOS File
- You Can't CAPA What You Can't Classify
- New USP Guidelines, Standards Address Lentivirus Characterization
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2193981513-3d-molecular-structure]( "Developing Consistent And Reproducible 3D Spheroid Models")
Developing Consistent And Reproducible 3D Spheroid ModelsImprove 3D spheroid consistency by optimizing cell selection, seeding density, and plate geometry. See how practical workflows and comparative data help reduce variability and establish reliability.
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![GettyImages-1935725164-disease-cell-blue]( "3D Neurospheres In Healthy And Alzheimer's: iPSC-Derived Neurons")
3D Neurospheres In Healthy And Alzheimer's: iPSC-Derived NeuronsExplore how different ApoE alleles influence Alzheimer's Disease risk using iPSC-derived neurons as well as gain insights into AD mechanisms and potential therapies.
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![GettyImages-1382353763-hand-bubble-co2-green]( "Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing")
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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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
Improve Speed To Market By Mitigating Vial And Stopper IncompatibilityThese studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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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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![GettyImages-1382353763-computer-medical-documents-review]( "Building A High-Quality IND From Scratch With Strategic Gap Analysis")
Building A High-Quality IND From Scratch With Strategic Gap AnalysisA biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).
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![Genomic DNA GettyImages-1311197612]( "Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products")
Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy ProductsNavigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.
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![bioprocess-facility-GettyImages-2286540867]( "Summary Of Gamma Irradiation Sterilization Validation")
Summary Of Gamma Irradiation Sterilization ValidationValidation, dose mapping, bioburden monitoring, and routine audits help ensure sterility assurance and support quality in bioprocess manufacturing.
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![mAb, monoclonal antibody, antigen, vaccine-GettyImages-2245122166]( "What Is Size Exclusion Chromatography (SEC)?")
What Is Size Exclusion Chromatography (SEC)?Aggregation can compromise mAb quality at many stages of development. Learn why size exclusion chromatography is a trusted approach for detecting aggregates and supporting confident characterization.
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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.
NEWSLETTER ARCHIVE
- 09.29.26 -- Capsid Selection And Tissue Targeting Begin Long Before Manufacturing
- 09.29.26 -- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- 09.28.26 -- The Integrated Path To Injectable Success
- 09.28.26 -- Why You Should Measure Comparability Debt Before Ever Starting A Study
- 09.25.26 -- The Promise Of MRD-Guided CAR-T Treatment
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
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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