GUEST COLUMNISTS

• In Bioprocessing, Trusted Data Is A Process Variable

  As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

• Combination Cell Therapy's Clinical Success Hinges On Manufacturability

  Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.