Featured Bioprocessing Editorial

1. The Complex Anatomy Of An ADC Tech Transfer 8/20/2026

   Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

2. What Goes Into Restarting A Shelved Orphan Drug Candidate? 8/19/2026

   The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

3. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

   Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

4. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

   The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

5. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

   Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

6. In Bioprocessing, Trusted Data Is A Process Variable 8/6/2026

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

7. Combination Cell Therapy's Clinical Success Hinges On Manufacturability 8/5/2026

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

8. Are Biopharma Companies Outsourcing Their Ability To Think? 8/5/2026

   Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

9. June 2026 — CDMO Opportunities And Threats Report 7/30/2026

   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.

10. The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable 7/29/2026

    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.