Featured Outsourcing Editorial
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How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
4/23/2026
Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.
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FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
4/22/2026
The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
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Mapping Candel Therapeutics' Sprint To The BLA Finish Line
4/22/2026
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
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Validating Candel's BLA-Ready Analytics Profile
4/22/2026
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
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The Hidden Operational Cost Contained In Every Small Molecule Portfolio
4/21/2026
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.
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U.S. Pharma Tariffs And MFN Become Law After April 2 Update
4/15/2026
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
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Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
4/15/2026
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
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How To Implement Post-Approval Changes On A Global Level
4/14/2026
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.
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The Business Case For Continuous Manufacturing In Biologics
4/14/2026
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.
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March 2026 — CDMO Opportunities And Threats Report
4/14/2026
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.