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 Your MES RFP Is Failing Before It Starts
- Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
- Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction
- Inside March Biosciences' CD5-Targeting CAR-T Approach
- Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Cell And Gene Therapy CDMOs: On The Path To $75 Billion in Services?
- The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Tailoring Viral Clearance Study Design
Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
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Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool
Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.
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A Study To Assess Organoid Size And Cell Count From 3D Image Analysis
Recent advancements in 3D patient-derived organoids (PDOs) offer improved predictive power over traditional 2D assays. Explore a patented bioprocess for PDO expansion that could revolutionize drug discovery, especially in oncology.
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Smart Scaling For Cell And Gene Therapies
To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
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From Variability To Validation – GMP Bioassay Success Through Partnership
Turn your inconsistent bioassays into GMP-validated, high-reliability platforms — just like we helped a biopharma partner cut failure rates from ~25% to <1%.
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Cell-Free Modeling Approach For Efficient Cell Culture Monitoring
Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.
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Expansion Of Human Bone Marrow-Derived MSCs
Achieving 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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Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead Technology
Scale up your manufacturing of adherent cell cultures used for viral vector-based treatments with the novel technologies needed to facilitate safe, rapid production.
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Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies
Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.
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Implementing Raman Spectroscopy For Automated Monitoring Of A Cell Culture Bioprocess
Discover how Raman spectroscopy and parallel bioprocessing enable real-time cell culture monitoring, saving time and providing crucial data for process optimization in biopharmaceutical production.
NEWSLETTER ARCHIVE
- 05.09.26 -- Cell & Gene Best Of April
- 05.08.26 -- Insights And Support For Clinical Trial Optimization
- 05.08.26 -- How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
- 05.07.26 -- Lilly's Unified Mindset For A Global Parenteral And Device Manufacturing Network
- 05.06.26 -- Regulatory Flexibility In CGT: Key Shifts & Implications With Monika Swietlicka
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
- Mitigating Challenges In Solid Tumor Delivery
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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