Featured Bioprocessing Editorial
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April 2026 — CDMO Opportunities And Threats Report
5/8/2026
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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Why Your MES RFP Is Failing Before It Starts
5/6/2026
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
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Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
5/5/2026
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
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Why Dilution Gets Tricky: The Role Of Measurement Variability
5/5/2026
Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.
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Gaining An Edge In GLP-1 Production
5/5/2026
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.
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Inside March Biosciences' CD5-Targeting CAR-T Approach
5/4/2026
Fratricide is one of the key reasons T-cell therapies targeting T-cell malignancies have faltered. March's approach aims to solve that with its MB-105 candidate.
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Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
5/1/2026
This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
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The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
4/30/2026
Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.
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Minimizing Regulatory Risk For Biologics Manufacturing Changes
4/29/2026
Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.
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Selecting The Right eQMS To Maximize Quality Maturity
4/23/2026
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.