FEATURE ARTICLES
Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.
- Where Contamination Control Really Breaks Down In Practice
- Trends In FDA FY 2025 Warning Letters
- Raising The Bar In Radiopharmaceutical Manufacturing
- SUS Interchangeability Assessment And Qualification Best Practices
- New MIT Consortium Links Innovation With Real-World Biomanufacturing
- 9 Pharma Trends To Watch In 2026
- Process Engineering's Key Role In Sterile Injectable Facility Design
PHARMA ONLINE WHITE PAPERS
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Enabling CDMOs To Focus On Core Priorities
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
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Expanding The Viscosity Limits Of Peristaltic Dosing12/17/2025
Discover how innovations in closed-loop control and mechanical design extend peristaltic dosing limits to 2000 cP, maintaining accuracy while preserving the advantages of sterile, disposable paths.
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Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide9/4/2025
Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.
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Guide To Pharmaceutical CAPA And Quality Management3/14/2025
CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.
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Performance Characteristics Of The Mobius® ADC Reactor For Conjugation10/22/2024
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
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White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges10/16/2024
Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 03.18.26 -- Struggling with mAb aggregation and other impurities?
- 03.17.26 -- Highlighting 50 Years of Excellence
- 03.16.26 -- Simplifying Complexity For Your Unique OSD Needs
- 03.14.26 -- Pharmaceutical Online Best Of February
- 03.13.26 -- Process Engineering's Key Role In Sterile Injectable Facility Design
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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Axplora Announces $60 Million High Potency API Manufacturing Facility Expansion In Italy3/17/2026
Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme in highly potent API (HPAPI) manufacturing at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale.
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BD Announces $110 Million To Support U.S. Pharmaceutical Supply Chain For Biologic Drugs3/16/2026
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a $110 million investment to expand its production of prefillable syringes, helping accelerate biologic and GLP-1 drug delivery and supporting pharmaceutical reshoring in the U.S.
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BD And Ypsomed Expand Partnership To Address Rapidly Growing Biologics Market3/16/2026
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Ypsomed, a leading developer of injection systems, are strengthening their collaboration with the development of a 5.5 mL version of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe.
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ROSS PDDM-10 Planetary Dual Disperser Delivers Unmatched Pilot-Scale Processing Flexibility3/10/2026
The ROSS Model PDDM-10 Planetary Dual Disperser is a near-universal pilot scale mixer designed to deliver high shear and controlled planetary agitation under vacuum, enabling rapid solids dispersion and producing air-free, high-quality pastes, slurries, gels and putties. It can also handle powder blending, granulation and vacuum drying requirements. This mixer processes up to 12 gallons per batch with a full holding capacity of 15 gallons.