Featured Editorial
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All Of Us Need To Be Rooting For The FDA
7/23/2025
In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.
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Here's What Limits AI's Outlook For Replacing Knowledge Workers
7/21/2025
Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.
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How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much
7/21/2025
In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.
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Tales From The Trenches: Developing Potency Assays Outside Big Pharma
7/18/2025
Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.
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FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline
7/17/2025
The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.
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Is Your Pharma Facility Ready For The Next Public Health Crisis?
7/17/2025
Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.
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FDA Leading The Decline Of Animal Testing
7/16/2025
The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).
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A Flexible Mindset For Bridging Between Cell-Based Assay Groups
7/16/2025
Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.
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Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation
7/16/2025
Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.
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Exploring Outsourcing's Role In CGT Scalability And Affordability
7/16/2025
CDMOs give therapy developers access to state-of-the-art production platforms and expertise without the massive up-front investment required for in-house manufacturing.