Featured Bioprocessing Editorial
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The Systems And Choreography Needed For Grade B ATMP Material Transfer
3/31/2026
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
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Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
3/27/2026
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
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Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
3/27/2026
Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
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Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
3/23/2026
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
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Generative AI Can Write The Code, But Who Builds In The Quality?
3/23/2026
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
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UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
3/20/2026
Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.
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February 2026 — CDMO Opportunities And Threats Report
3/20/2026
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.
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COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
3/20/2026
Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.
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FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
3/19/2026
FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.
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All The Ways Global Biopharma Still Grapples With Annex 1
3/19/2026
Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.