FEATURED EDITORIAL
As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
- 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
- CDMO Live Europe 2026: Partnerships For An Uncertain World
- Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
GUEST COLUMNISTS
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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.
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Let's Stop Treating Allogeneic Cell Therapy As One Thing
Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.
PHARMA OUTSOURCING WHITE PAPERS
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Pharmaceutical Spray Drying – Technology And Applications
Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.
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AI Implementation To Enhance Quality
Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
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The TIDES Manufacturing Mandate: Why Incrementalism Fails And Integration Prevail
Manufacturing strategies for peptides and oligonucleotides are being reshaped by scale, complexity, and chronic use. An integrated, end‑to‑end approach shows how early design decisions can prevent costly bottlenecks later.
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Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability
Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based antibody drug conjugates and enhance ADC development processes.
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Random And Semi-Targeted Integration In Cell Line Development
While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.
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Why An Integrated Approach Ensures Smooth Entry Into The European Market
Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Formulation Development Of Enterically Protected Spray Dried Dispersions
- Accelerated LVV Manufacturing Enabled By Platform Excellence
- Unlock 14% Reduction In AAV Gene Therapy Cost Of Goods
- Covalent Warhead Reactivity: A New Look At GSH Reactivity Assays
- Partnering With Health Systems: Essential Tips For CGT Commercialization
REPORTING
PRODUCTS & SERVICES
ON-DEMAND WEBINARS
- 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
- July Kincell Bio Webinar