Featured Bioprocessing Editorial
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The Future Of Biotech Outsourcing: Essential Skills For Program Managers
11/24/2025
The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.
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Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
11/21/2025
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
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A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work
11/21/2025
Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.
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An End-To-End Automated HTP Platform For Cell Line Optimization
11/20/2025
Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.
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Here's What You Need To Know About The Access Consortium Pathway
11/20/2025
Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.
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FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK
11/19/2025
The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.
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Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
11/18/2025
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
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AI Is Not The CMC Revolution You're Looking For, And That's OK
11/18/2025
Advanced therapy development today is less about big funding, more about frugality. Artificial intelligence unlocks a competitive advantage.
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Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development
11/17/2025
The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
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How To Improve Sponsor–CMO Collaboration Around Digital Deviations
11/17/2025
Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.