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- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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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![Scientists in lab-GettyImages-1441665026]( "Optimize Time, Space and Cost With Inline Buffer Formulation And System")
Optimize Time, Space and Cost With Inline Buffer Formulation And SystemDiscover how integrating inline buffer formulation with chromatography reduces buffer waste by 50% and delivers a 710% ROI, transforming downstream efficiency and sustainability.
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Meet Regulation Requirements With RTU Vials And Cartridges10/9/2025
Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.
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Alleviate Compliance Risks With Your EAM/CMMS3/2/2026
Discover how unified asset management enhances audit readiness by connecting maintenance, calibration, and quality insights, as well as how integrated workflows reduce compliance risk.
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Insights And Effective Strategies For A Successful Technology Transfer11/1/2024
Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.
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Unlocking Operational Capacity With Digitalized Cleaning Validation6/2/2026
Digitalizing cleaning validation reduces inefficiencies, strengthens data integrity, and improves audit readiness. See how integrated systems can continuously optimize manufacturing performance.
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Why Choose Robotic Processing For Small Batch Aseptic Filling1/9/2026
Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation
- Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors
- A Human-Relevant Model Of The Liver Sinusoid
- Evaluating The Ruggedness Of An Advanced HPLC System For SEC Separations
- Engineering The Future Of Lipsomal Drug Delivery
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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![white coupon banner, great topic-GettyImages-2271702407]( "Let Your Voice Help Shape Pharma Manufacturing")
Let Your Voice Help Shape Pharma ManufacturingPharmaceutical 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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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese 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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![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.
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.
