FEATURE ARTICLES
Though I still have a great deal to learn about the pharmaceutical industry, I am surrounded by a warm and incredibly bright cast of editors that I gain knowledge from every day.
- Top 7 AI Lessons Learned
- An AI Use Case in Pharma Process Optimization
- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
- November 2025 — CDMO Opportunities And Threats Report
- What 2025 FDA Warning Letters Tell Us About GMP Compliance
- Unpacking The EU's Mutual Recognition Agreements For Pharma
- It's Copy/Paste In Fleet Management Manufacturing
PHARMA ONLINE WHITE PAPERS
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![edgewipe]( "Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know")
Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To KnowThis guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.
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Enabling Digital Twins With Computational Fluid Dynamics Modeling1/16/2025
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
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Tools For Efficient And Reliable Gene Therapy Manufacturing11/5/2025
Discover scalable strategies for overcoming AAV purification challenges, from low yield and impurity removal to serotype variability, as well as how advanced tools can streamline manufacturing.
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Ready To Demystify Organoids?7/1/2025
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
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Aggregation In Antibody-Drug Conjugates: Causes And Mitigation9/1/2025
Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
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A Strategic Guide For Biotech And Biopharma Leaders5/15/2025
Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Generation Of A Contamination Control Strategy
- Integrating Phase-Appropriate Quality Standards
- Predicting Human Liver Damage With A More Accurate In Vitro Hepatotoxicity Assay
- Development Of Separation Methods For GLP-1 Synthetic Peptides
- Custom Mobile Pharmacy Cleanroom Trailer For Oncology Infusion Pharmacy Services
NEWSLETTER ARCHIVE
- 01.09.26 -- Høeg In, Pazdur Out At The FDA
- 01.08.26 -- Fostering A Quality Software Culture
- 01.08.26 -- STREAM Edition: The Editors' Roundtable: A 2025 Retrospective Of The Life Science Industry
- 01.06.26 -- Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
- 01.02.26 -- Is Charisma An API?
INDUSTRY NEWS
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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.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter 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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![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-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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Sharp Sterile Manufacturing Increases Capacity With $28 Million Investment Featuring New IMA Isolated Vial Filling Line1/8/2026
Sharp Sterile Manufacturing has today announced a $28 million expansion of its site in Lee, Massachusetts. The enhanced state-of-the-art facility will strengthen opportunities for highly skilled engineering and pharmaceutical manufacturing roles within the local life sciences community and represents a major milestone in Sharp Sterile’s development.
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CDMO GBI Biomanufacturing Announces New President1/6/2026
GBI Biomanufacturing, a U.S.-based biopharmaceutical CDMO providing integrated development and cGMP manufacturing services for complex biologics, today announced that Jesse McCool, Ph.D. has been appointed President.
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Symbiosis Initiates Commercial Drug Manufacturing At New FDA-Inspected Production Facility1/6/2026
(Symbiosis), a leading sterile fill finish contract manufacturing organisation (CMO), has manufactured their first 10,000 vial batch at the company’s new facility in Stirling, UK.
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Samsung Biologics Expands U.S. Manufacturing Capabilities With Strategic Acquisition Of Human Genome Sciences From GSK12/22/2025
This strategic move secures Samsung Biologics’ first U.S.-based manufacturing site, a significant expansion of the company’s global footprint and its long-term commitment to the U.S. market.
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Techceuticals Releases 2026 Schedule For In-Person Solid Dosage Manufacturing Training12/19/2025
Techceuticals has announced its 2026 training schedule for solid dosage manufacturing, featuring a full lineup of two-day, hands-on courses covering tablet making, encapsulation, granulation, film coating, and end-to-end solid dosage processes.
