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.
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- Europe's ATMP Opportunity Still Requires Local Navigation
- The Unspoken Truth About Cell Therapy Product Understanding
- Overcoming Recovery Challenges In AAV Production
- In Vivo CAR T Needs More Than Better Cell Engineering
- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- Implementing And Optimizing Your eQMS
- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Automated Enrichment Of Human CD34+ Cells
Explore 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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Finding An Optimal Harvest Solution By Considering Both Cost And Sustainability
Optimize your bioprocessing harvest with single-use centrifugation. Reduce costs, waste, and space needs compared to traditional depth filtration methods.
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A Novel Approach To Improving AAV Titers
As demand for AAV-based therapies rises, optimizing production processes is essential. By utilizing existing technologies, tailored platforms, and optimized formulations, titers and productivity can be enhanced.
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Collaborative Variability Reduction In Cell Culture Media
Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.
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Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success
The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.
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Guiding Principles For Process Development And IND Readiness
Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.
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The Case For Non-Viral Circular Single-Stranded HDR Donors
Enable efficient, low-toxicity genome editing without viral vectors. This cell-free circular ssDNA platform preserves stem cell fitness while supporting scalable manufacturing.
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Automation Of iPSC Culture, Passaging, And Expansion
Find out how iPSC-derived models enable researchers to generate diverse cell types and tissues as well as how automation reduces the labor-intensive culturing process with AI-powered decision-making.
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Accelerate LNP Manufacturing With Automated Process Development
Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.
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Ensuring Product Safety And Purity With Mycoplasma And Sterility Testing
Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.
NEWSLETTER ARCHIVE
- 09.01.26 -- Reimagining Solid Tumor Immunotherapy Through Engineered Tregs With CoRegen's Dr. Sonal Gupta
- 09.01.26 -- Unlocking The Future Of Cell And Gene Therapies
- 08.31.26 -- Next-Gen Cell & Gene Manufacturing Solutions
- 08.31.26 -- Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- 08.29.26 -- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
- Building Antigen-Specific Immune Tolerance For Autoimmune Disease
- Solving Vector Yield Challenges Starts Long Before Manufacturing
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.
More Content Collections