FEATURE ARTICLES
Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.
- Chugai Accelerates Automation To Boost Operational Efficiency
- The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process
- CDMO Selection: Start With The Relationship, Not The RFP
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Navigating Rough Pharma Seas With Collaboration
PHARMA ONLINE WHITE PAPERS
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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Quality By Design In The Pharmaceutical Industry12/12/2025
Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
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Streamlining Early Drug Development: Efficient Synthesis Of Highly Potent Compounds5/6/2026
Discover how risk‑based, phase‑appropriate synthesis enables safe, efficient production of highly potent compounds while balancing speed, worker safety, and regulatory readiness in early development.
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FDA's Regenerative Medicine Advanced Therapy (RMAT) Program12/10/2025
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
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Accelerating An Innovative High Potency Oncology Therapy To Market5/13/2026
Learn how disciplined containment, proactive risk management, and collaboration accelerate complex oncology programs under tight timelines while protecting quality, safety, and global launch readiness.
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Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements4/8/2025
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 06.05.26 -- Process Equipment Spotlight: Lab Advances Innovations
- 06.04.26 -- From Partnerships To RNA: Trends Redefining Biopharma
- 06.04.26 -- Closing The MES Value Gap: Why Technology Isn't The Problem
- 06.04.26 -- STREAM Edition: Interventions And Automation
- 06.02.26 -- Navigating Combination Product Development For Novel Biologics
INDUSTRY NEWS
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ISPE Announces 2026 FOYA Winners
These awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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Høeg In, Pazdur Out At The FDA
What an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
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9 Drugs Granted Fast Track By FDA's Voucher Program
With targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
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Leaders In The Excipient Market: Region And Type
Though North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.
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Pfizer Strengthens Obesity Foothold With Metsera Acquisition
After discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
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Veranova Appoints Dr. Bob Huang Vice President And General Manager Of West Deptford Site6/3/2026
Veranova today announced the appointment of Dr. Bob Huang as Vice President and General Manager for its West Deptford, New Jersey facility. He will lead site operations, advance strategic growth initiatives, and strengthen manufacturing excellence and customer delivery.