FEATURE ARTICLES
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
- Why Supplier Diversification Doesn't Ensure Supply Safety
- Oral Combination Therapies: Navigating Development Complexities
- Building Trust In AI For Computerized System Validation
- When To Trust And When To Verify AI-Enabled Validation Systems
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- Using Digital Platforms To Find Your CDMO
- AI Governance Is Just Like Driving A Race Car
PHARMA ONLINE WHITE PAPERS
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![GettyImages-172962854 screen]( "OEE And Product Inspection")
OEE And Product InspectionExplore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.
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Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know10/29/2025
This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.
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Modern Containment Solutions In OSD Processes6/15/2026
Outdated containment infrastructure in OSD facilities creates costly compliance gaps and operational bottlenecks. Flexible single-use isolator systems offer a faster, more adaptable path forward.
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Insights And Effective Strategies For A Successful Technology Transfer11/1/2024
Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.
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Food Safety Digital Maturity In The Supply Chain3/17/2026
Look at how connected data and automated processes strengthen safety, improve traceability, and streamline compliance across the supply chain—offering a clear roadmap for progression.
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Small Molecule API Production: Unveiling The Impact Of Fermentation3/17/2026
Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Native RPLC For ADCs: How Column Hydrophobicity Shapes DAR Separation
- Anticoagulant Selection Influences T Cell Purity And Yield In Whole Blood Isolation
- Solving The Challenges Of Transdermal Patch Package Integrity
- How Can You Avoid Bioprocessing Risks When Using Cable Ties?
- Particle Removal In Drug Production
NEWSLETTER ARCHIVE
- 09.16.26 -- Fewer Setbacks, Faster INDs Through Smarter Chemistry Development
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
- 09.15.26 -- AI Governance Is Just Like Driving A Race Car
- 09.15.26 -- Your Collaborator: mAb Productivity And Robustness
- 09.12.26 -- Pharmaceutical Online Newsletter - Best Of August
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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Hovione Opens New Facility At New Jersey Campus, Doubling U.S. Spray Drying Capacity9/16/2026
Hovione, a globally-integrated pharmaceutical Contract Development and Manufacturing Organization (CDMO), has opened 89 Twin Rivers, a new 31,000-square-foot facility at its East Windsor, N.J. campus that doubles the company's U.S. spray drying capacity and further reinforces Hovione´s global leadership in this technology platform.
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Samsung Biologics Signs USD 262 Million Manufacturing Agreement With European Pharmaceutical Company9/15/2026
Samsung Biologics’ new $262 million manufacturing agreement, extending through 2033, underscores strong long-term demand and business momentum as the company rapidly expands its global capacity, capabilities, and portfolio to support continued growth.
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Jubilant HollisterStier Announces First FDA Commercial Product Approval For Sterile Fill-Finish Line 39/10/2026
Jubilant HollisterStier (JHS) is pleased to announce the FDA regulatory approval of the first commercial sterile injectable product manufactured on its Line 3 isolator fill-finish line, marking a major milestone for the company’s expanded manufacturing operations at its Spokane facility.
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Lonza Further Strengthens US Manufacturing Presence With Addition Of A Commercial Spray-Drying Facility In Bend, Oregon9/10/2026
Lonza, the world’s leading contract development and manufacturing organization (CDMO), announced today plans to further strengthen its significant US presence by constructing a large-scale commercial spray-drying facility in Bend, Oregon. The investment will establish Lonza as the leading CDMO provider of commercial-scale spray-drying PSD-4 capacity in the US.
