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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![GettyImages-1455725431-production-vials-vaccine]( "Validation And Qualification Approach In New Annex 1 Revision")
Validation And Qualification Approach In New Annex 1 RevisionThe new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
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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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Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S112/10/2024
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.
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A Powerful Non-Destructive Tool For Tablet Characterization10/6/2025
Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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Build An AAV8 Platform: Lessons From A Collaborative Development Journey11/5/2025
Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.
PHARMA ONLINE APP NOTES & CASE STUDIES
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.
