FEATURE ARTICLES
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
- A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
- Tackling OSD Manufacturing Challenges With Pharma 4.0 Digital Innovation: Overview
- At Base Camp: Lilly's Manufacturing Capacity Journey
- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
- January 2026 — CDMO Opportunities And Threats Report
- Solving The Top 3 Pharma Packaging/Manufacturing Issues
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
PHARMA ONLINE WHITE PAPERS
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Pave The Way To High Productivity With Continuous Manufacturing For Pharma
Continuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.
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Building the Next Generation of TIDES Manufacturing Excellence2/12/2026
Rising demand for complex TIDES therapies is shifting manufacturing expectations, driving adoption of continuous processing, digital tools, stronger supply strategies, and greener, scalable synthesis.
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Building A Compelling Business Case For Quality Transformation2/26/2024
Discover the key to a successful quality transformation, explore the business value of modern quality systems, and learn how quality leaders can build a compelling case for change.
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Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing8/22/2024
Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.
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Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter11/10/2025
Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.
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Unpacking FDA's Final Rule To Regulate LDTs3/14/2025
Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.
PHARMA ONLINE APP NOTES & CASE STUDIES
- A Temperature-Stable Replacement For Animal Trypsin In Cell Dissociation Applications
- Automation Of 3D Intestinal Organoids Culture
- Successful Method Migration Of The USP Quetiapine Fumarate Impurities Method
- Leveraging A Modern HPLC System For Peptide Drug Substances Analysis
- How A Leading CDMO Reduced Yield Variability With Automation
NEWSLETTER ARCHIVE
- 02.21.26 -- Aseptic Contract Manufacturing Services
- 02.20.26 -- Lessons In Quality From Sanofi's Plai.qa
- 02.19.26 -- STREAM Edition: Regulatory Guidance For Cleaning And Disinfecting
- 02.18.26 -- How To Break Through Fill/Finish Bottlenecks
- 02.17.26 -- Solving The Top 3 Pharma Packaging/Manufacturing Issues
INDUSTRY NEWS
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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.
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FDA Cracks Down On GLP-1 Imports
GLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.
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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Syntegon Launches AIM9 High-Speed Inspection Platform2/18/2026
Based on decades of experience and proven technology, Syntegon is launching the AIM9 inspection platform. It combines visual inspection and leak detection with outputs of up to 600 vials per minute, helping pharmaceutical manufacturers and CMOs achieve the highest inspection and product quality.
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JHS CEO Chris Preti Receives 2026 Person Of Influence Award2/12/2026
Spokane, WA. - The Spokane Journal of Business named Chris Preti, CEO of Jubilant HollisterStier (JHS), as one of its 2026 People of Influence.
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Subcutaneously Administered Nanotrastuzumab Matches Performance Of Herceptin HYLECTA In Minipig Study2/12/2026
Nanoform Finland Plc, the medicine performance-enhancing company, announced the results from a preclinical study designed to compare the tolerability and pharmacokinetics of Nanotratsuzumab, a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery versus Herceptin HYLECTA™, a co-formulated product with Halozyme’s proprietary hyaluronidase enzyme marketed by Roche/Genentech.
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A New Chapter In ROIS Commercial Leadership2/11/2026
ROIS today announced the appointment of Kimberlee Steele as Chief Commercial Officer, effective from 1 March 2026.