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.
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Car T cells attacking cancer cells-GettyImages-1171781191]( "Accelerate Drug Discovery With Real-Time Cell Interaction Insights")
Accelerate Drug Discovery With Real-Time Cell Interaction InsightsDecoding immune cell interactions reveals critical insights for cancer therapy. Advanced imaging and spectral analysis enable precise identification of synapses, accelerating immuno-oncology research.
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![GettyImages-2165446110 lab, flow cytometry, research]( "A Toolkit For Unraveling Protein Expression Patterns")
A Toolkit For Unraveling Protein Expression PatternsLearn about a method that utilizes monoclonal antibodies and flow cytometry to analyze the metabolic state of individual immune cells, advancing immune research and immunotherapy.
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![gettyimages_1331137712_regulatory]( "Boosting CMC Regulatory Efficiency In Gene Therapy")
Boosting CMC Regulatory Efficiency In Gene TherapyEnsure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
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![Cell Lab GettyImages-1183901928]( "The Complete Flow Cytometry Guide")
The Complete Flow Cytometry GuideThis guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
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![GettyImages-533937117-mrna-chemicals]( "Improving CD Media Titers With Nu-Tek Peptones")
Improving CD Media Titers With Nu-Tek PeptonesAdding 0.2% soy peptone to chemically defined media increases CHO IgG production by 30–60%. This animal-free supplementation enhances titers while maintaining high process control.
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![GettyImages-1347856166 tube, research, lab]( "Overcoming Scale-Up Challenges In iPSC Production: A Joint Investigation")
Overcoming Scale-Up Challenges In iPSC Production: A Joint InvestigationDiscover how new processing methods tackle challenges in large-scale stem cell production and how automated, low-shear processing maintains cell health and pluripotency across production scales.
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![GettyImages-1583149311 biomanufacturing, automation, robotics]( "Enhancing Preclinical Cell Therapy Development")
Enhancing Preclinical Cell Therapy DevelopmentAutomation in cell therapy development boosts reproducibility, reduces error, and enhances yield. Learn how it’s reshaping preclinical workflows and accelerating clinical trial readiness.
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![GettyImages-1354923731-magnifying-glass-mrna]( "IVT mRNA Encapsulation Efficiency Assessment")
IVT mRNA Encapsulation Efficiency AssessmentIn vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
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![GettyImages-506999858-scientists-cell-culture-lab-development]( "Engineering Reliability In Cell Therapy Manufacturing")
Engineering Reliability In Cell Therapy ManufacturingA cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.
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![Computer Science Research Laboratory with Robotic Arm Model-GettyImages-968289652]( "End-To-End Workflow Integration For Antibody Development")
End-To-End Workflow Integration For Antibody DevelopmentModern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.
NEWSLETTER ARCHIVE
- 06.16.26 -- Reduce mAb Aggregates: Practical Strategies
- 06.16.26 -- STREAM Edition: When Should CGT Companies Keep Manufacturing In-House?
- 06.16.26 -- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- 06.15.26 -- Discover The Capabilities Driving Next-Generation Biologics
- 06.15.26 -- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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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