FEATURE ARTICLES
Modular facility concepts offer a different path, giving manufacturers the ability to expand capacity stepwise, standardize core infrastructure, and adapt production environments as product portfolios evolve
- Transforming Computer System Validation In The Life Sciences Industry
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- How To Avoid The Biggest USP <665> Compliance Trap
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- Inside Chugai's Digital Infrastructure Strategy
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
PHARMA ONLINE WHITE PAPERS
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Three Key Actions To Minimize Dead Volumes
Minimizing liquid dead volume helps labs conserve costly reagents and scarce samples while boosting assay throughput. Learn how advanced liquid level detection technologies are driving efficiency.
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Why Pharmaceutical Scientists Trust The Discovery Core Rheometer5/1/2026
Drug formulations demand more than single‑point viscosity data. Explore how rheology reveals stability, flow, and structural behavior across suspensions, topicals, and injectables.
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Three Key Strategies To Guide Efficient And Effective Recall Management2/18/2025
Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.
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A Patented Process For Intermediates Useful For Upadacitinib2/18/2026
Discover how innovative and safer synthetic strategies can streamline the manufacture of Upadacitinib while addressing the complexity and safety challenges inherent in its key intermediates.
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Safe Syringe Solutions For Lipid Nanoparticles7/1/2026
Prefilled syringes improve lipid nanoparticle dosing accuracy and administration. Advanced containment solutions with cross-linked coatings preserve stability and accelerate development timelines.
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From Open Cleanrooms To Closed Systems – What Is Driving The Change?3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Sample Preparation Automation For Immunosuppressant Drug Analysis
- Assessing Viability And Real-Time Apoptosis/Necrosis
- Secondary Packaging: Labeling, Cartoning, Clamshell, And Stretch Carding
- Using DSC And MDSC To Study Material Interactions Of APIs And Excipients
- Boosting Cell Culture Yields With Intensified Fed Batch Processing
NEWSLETTER ARCHIVE
- 07.17.26 -- Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?
- 07.16.26 -- Human-Centric Models For Modern Drug Development
- 07.16.26 -- What Biopharma Often Overlooks In A Scheduled Shutdown
- 07.16.26 -- STREAM Edition: High-Volume GLP-1 Manufacturing: Challenges And Bottlenecks On A Global Scale
- 07.14.26 -- Practical Strategies for Contamination Control and EM Compliance
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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Amneal's Planned Sterile Facility Creates Opportunity For Aseptic Filling, Isolator, And Automation Suppliers7/8/2026
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced it has been selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA PreCheck Pilot Program for the company's planned sterile manufacturing facility in Brookhaven, New York.
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AustinPx Expands KinetiSol™ Technology Commercial Access Through Thermo Fisher Scientific Collaboration6/30/2026
AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement for orally delivered small molecule drugs, today announced its agreement with Thermo Fisher Scientific’s Patheon pharma services for the installation of AustinPx’s KinetiSol™ Technology equipment.
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Recipharm Invests In U.S. Fill-Finish Infrastructure To Accelerate Biologics Development6/17/2026
Recipharm, a leading global contract development and manufacturing organisation (CDMO), today announced a multi-million-dollar investment in its US operations, strengthening its ability to support pharmaceutical and biotechnology companies with advanced sterile fill and finish services for biologics and advanced therapies.
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Four Myths About Embedded CMOs, Busted6/17/2026
If you’re looking for a contract manufacturer to bring your therapy to market, you’re far from alone. Demand for manufacturing services is shaping the pharma Contract Manufacturing Industry, with analysts predicting a growth rate of nearly 7% per year until 2028.