Guest Columns
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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.
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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
4/17/2025
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
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Pharmaceutical Sovereignty: The Resilience We Cannot Outsource
4/15/2025
Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration.
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How AI Is A Game-Changer For Auditing Compliance And Efficiency
4/9/2025
In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.
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A Closer Look At Buffer Recycling For More Sustainable Bioprocessing
4/8/2025
Recognizing the unexplored potential to save resources, one researcher realized consumption reduction of up to 50% during a key phase of downstream processing.
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Struggling With GxP Systems? There's A DAP For That
4/2/2025
A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.
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Risk Management Planning: Be Prepared When Disaster Strikes
4/1/2025
Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.