Featured Bioprocessing Editorial
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Do We Really Understand Plasmid Quality's Effects On mRNA Production?
5/1/2025
Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.
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Using Virtual Reality To Enhance Aseptic Contamination Control
5/1/2025
Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.
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Lean Thinking For Pharma — Flow Without Facility Upheaval
4/28/2025
Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.
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A Checklist For Mechanism-Based Potency Testing In Cell Therapy
4/25/2025
New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.
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FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating
4/24/2025
Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.
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PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand
4/24/2025
Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Common Manufacturing Challenges For LBP Formulations
4/23/2025
As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.
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What CDMOs Wish Biotechs Knew Before Submitting An RFP
4/23/2025
This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership.
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8 Actions To Redefine Sponsor–CDMO Relationships
4/22/2025
When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.