FEATURE ARTICLES
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
- 6 Reasons Pharma Manufacturing Has Eyes On Puerto Rico
- June 2026 — CDMO Opportunities And Threats Report
- Reshoring Pressure Meets Manufacturing Reality
- CDMO Live Europe 2026: Partnerships For An Uncertain World
- Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
- Building AI Readiness Through Cross Collaboration
- Bayer Adds A Spine To Modularity For Scale Without Disruption
PHARMA ONLINE WHITE PAPERS
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![sterile cleanroom protective gear]( "Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems")
Global Regulatory Harmonization: Comparisons In Aseptic Barrier SystemsCompare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
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The Complete Guide To Immunohistochemistry9/24/2024
Immunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
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The Impact Of Artificial Intelligence On CQV7/23/2025
AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
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Automated Validation And Centralized Data7/23/2025
Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.
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EMA Support For Rare Disease Therapies6/10/2025
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
INDUSTRY NEWS
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![white coupon banner, great topic-GettyImages-2271702407]( "Let Your Voice Help Shape Pharma Manufacturing")
Let Your Voice Help Shape Pharma ManufacturingPharmaceutical Online hosts live virtual panels with industry experts on important topics and challenges, and we want to know what topics are important to you. Please consider taking a few minutes of your time to tell us what they are.
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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese 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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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat 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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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith 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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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough 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.
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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METTLER TOLEDO Introduces LightningBuild Program For Four-Week Delivery8/13/2026
METTLER TOLEDO Product Inspection Group introduces its LightningBuild program, which delivers select product inspection systems from purchase order to the customer’s dock within four weeks. The program is launching with the X12 LightningBuild x-ray inspection system and the C31 LightningBuild checkweigher, both on exhibit for the first time at Pack Expo in booth 2122. Available at no additional charge, LightningBuild is designed for food and pharmaceutical manufacturers that need to start, expand or adapt operations quickly.
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Ypsomed Opens Production Site In China8/12/2026
