FEATURE ARTICLES
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
- Implementing And Optimizing Your eQMS
- Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
- The Complex Anatomy Of An ADC Tech Transfer
- A Much-Improved Approach For Understanding And Managing Safety Risks
- CSV Assumes The AI System Sits Still — It Doesn't.
- AI Needs Human Oversight To Better GMP Documentation
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
PHARMA ONLINE WHITE PAPERS
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Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
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.
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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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Accelerated Development Of Solid Oral Dosage Formulation For IND Submission12/11/2024
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
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Leveraging Integrated Electronic Laboratory Notebook And Inventory Systems6/15/2026
Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development.
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The Future Of DMTA In Drug Discovery And Development5/28/2026
AI‑enabled DMTA cycles connect design, experimentation, and analysis through structured data and automation, reducing manual handoffs while accelerating discovery, development, and CMC decision‑making.
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Evaluation Of Novel Process Indicators For Hydrogen Peroxide Decontamination6/30/2026
Immediate, quantifiable verification replaces seven-day incubation periods. Discover how enzyme-based indicators optimize hydrogen peroxide decontamination.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Assessing Viability And Real-Time Apoptosis/Necrosis
- Peptide Mapping Of Adeno Associated Virus Capsid Proteins
- Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation System
- Overcoming API Constraints And Tight Timelines With On-Demand Manufacturing
- From 51% Yield To 87% With Targeted Impurity Removal
NEWSLETTER ARCHIVE
- 08.30.26 -- AI Needs Human Oversight To Better GMP Documentation
- 08.28.26 -- Capabilities For Choosing The Right CDMO For Cell Line Development Success
- 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery
- 08.27.26 -- CSV Assumes The AI System Sits Still — It Doesn't.
- 08.27.26 -- Changing Inspection Readiness Into Continuous Improvement
INDUSTRY NEWS
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Let Your Voice Help Shape Pharma Manufacturing
Pharmaceutical 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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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.
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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JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program8/28/2026
Jubilant HollisterStier(JHS) and Altoura will be of only three company-CDMO pairs participating in the BioTools Innovator VANGUARD Level Up-XR Program.
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Syntegon Launches New Pilot Scale Tablet Coater For Small Batches8/26/2026
Syntegon, a strategic lifecycle partner to the pharmaceutical and biotech industry has expanded its Oral Solid Dosage (OSD) processing portfolio with the Sepion 75. The new pilot-scale tablet coater designed to support manufacturers and CDMOs in handling growing product diversity, smaller and more variable batch sizes, and stricter containment requirements for highly potent active ingredients. The new coater completes the established Sepion series and supports consistent scale-up, faster flexible batch processing, and containment-oriented manufacturing.
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Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities8/25/2026
Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced the successful completion of three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA). The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network.
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CleanSpace Names Pharma Industry Veteran Will Knapp Midwest Sales Director8/25/2026
Will Knapp joins CleanSpace as Director of Sales for the Midwest, bringing morethan 25 years of pharma facility design, construction, and validation expertise.
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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.