FEATURED EDITORIAL
Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.
- The Metaphoric Rise Of Outsourcing
- In Vivo's Biggest Threat — Comparison To Old Models
- Managing Supply Chain Risk In Scale-Up And Multisite Trials
- The Industrialization Of Advanced Modalities
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
GUEST COLUMNISTS
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In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
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Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
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The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
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Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
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Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
From regulatory fragmentation to cold chain risks, discover how strategic action, data visibility, and resilient design keep clinical trials on track.
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December 2025 — CDMO Opportunities And Threats Report
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.
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Do's And Don'ts Of Material Handling When Retrofitting For ADCs
Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.
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Building Enterprise Resilience From QRM Signals
Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.
PHARMA OUTSOURCING WHITE PAPERS
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Stopper Migration In Frozen Pre-Filled Syringes
Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.
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Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner
Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.
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Factors To Consider While Selecting Stoppers For Lyophilized Vials
Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.
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Protein Stress Testing
Start your forced degradation studies early to uncover molecular risks, strengthen product stability, and ensure regulatory-ready development from the start.
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Accelerating ADC Clinical Development Timelines
For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.
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Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Cell Culture Media Mixing In A Benchtop Single-Use Mixer
- CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics
- Lentiviral Vector Production Using Single-Use Bioreactors
- Overcoming The Solubility Challenges Of Antibody-Drug Conjugates
- Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations