Featured Bioprocessing Editorial
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Where Contamination Control Really Breaks Down In Practice
3/13/2026
Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.
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Trends In FDA FY 2025 Warning Letters
3/13/2026
The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.
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SUS Interchangeability Assessment And Qualification Best Practices
3/12/2026
Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.
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Accelerating Technology Diffusion In Cell And Gene Therapy
3/11/2026
Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.
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5 QMS Blind Spots You Should Know About
3/6/2026
Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
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New MIT Consortium Links Innovation With Real-World Biomanufacturing
3/6/2026
In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.
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Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
2/27/2026
By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.
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Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
2/27/2026
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
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The Real Reason We Haven't Fully Automated Cell Therapy Yet
2/26/2026
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
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The Hidden Engineering Behind Successful Upstream Bioprocessing
2/25/2026
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.