FEATURED EDITORIAL
Tales of purpose-led careers that bring innovations to business leaders and opportunities to university students. They inspire us. Chief Editor Louis Garguilo documents two such professionals who have combined to help domestic manufacturing organizations locate each other and power their operations, and to get students involved in the industry.
- Combination Cell Therapy's Clinical Success Hinges On Manufacturability
- Are Biopharma Companies Outsourcing Their Ability To Think?
- Global Ties, Good Fortune Bind Biotech And CDMO
- June 2026 — CDMO Opportunities And Threats Report
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
- Reshoring Pressure Meets Manufacturing Reality
GUEST COLUMNISTS
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Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
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June 2026 — 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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The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
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Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
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Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
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CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
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Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
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Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
PHARMA OUTSOURCING WHITE PAPERS
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Advances In High-Concentration Protein Formulation Development
High-concentration protein formulations improve patient convenience but face challenges like viscosity, aggregation, and surfactant degradation. Innovative strategies optimize stability, scalability, and quality for advanced biologics development.
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Why Biopharma Breakthroughs Aren't Moving The Market
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing
Decarbonizing 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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Boosting CMC Regulatory Efficiency In Gene Therapy
Ensure 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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Enabling Digital Twins With Computational Fluid Dynamics Modeling
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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ON-DEMAND WEBINARS
- Life Cycle Assessment (LCA): Empowering Sustainable Decisions
- Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies
- Enhancing AAV Manufacturing Yield Via Mini-Helper Plasmid
- When High-Stakes ADC Decisions Can't Wait for More Material or Better Data
- Beyond Outsourcing: Turning Your CDMO Into A Value-Creation Engine