FEATURE ARTICLES
This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
- A 5-Step Foundation For Early CQV Involvement
- Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline
- Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals
- Selecting The Right eQMS To Maximize Quality Maturity
- BCS Class IV: Rescuing Hard To Deliver Molecules With Nanoformulation
- FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
- Challenges And Solutions In Aseptic Evolution
PHARMA ONLINE WHITE PAPERS
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![rules, policies, regulatory documents-GettyImages-1438925546]( "Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies")
Annex 1: Sterile Fill/Finish For Early Phase Clinical SuppliesMeeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.
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Quality By Design: The Importance Of Reference Standards In Drug Development8/1/2024
Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.
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How To Avoid Sticking And Picking In The Tableting Industry9/23/2024
Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.
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Why Biopharma Breakthroughs Aren't Moving The Market10/20/2025
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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What Pharma And Biopharma Should Know About Container Closure Integrity8/1/2024
Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges
- Use Cation Exchange Chromatography For High Yields In Vaccine Production
- Advancements In GLP-1 Analog Formulation: Overcoming Challenges
- Maximizing Scale-Up Efficiency Of A mAb Upstream Process
- A High-Throughput Platform For Fast And Reliable Clone Screening
NEWSLETTER ARCHIVE
- 05.02.26 -- Quality Assurance Product Showcase
- 05.01.26 -- ISPE Announces 2026 FOYA Winners
- 04.30.26 -- The Hidden Operational Cost Contained In Every Small Molecule Portfolio
- 04.30.26 -- STREAM Edition: Selecting Equipment And Technology
- 04.29.26 -- Navigating an Evolving Pharma Landscape with Strong CDMO Partnerships
INDUSTRY NEWS
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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.
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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.
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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Compact & Powerful Double Planetary Mixer For Lab And Pilot-Scaling4/30/2026
ROSS has delivered an ergonomic and powerful Double Planetary Mixer Model DPM-10 engineered for high-viscosity and specialty material processing in laboratory and pilot-scale operations.
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AES Cleanroom Technology appoints John Groth As Chief Revenue Officer4/27/2026
AES Cleanroom Technology, a leading provider of modular cleanroom design, manufacturing, and construction solutions for the life sciences and biopharmaceutical industries, has appointed John Groth as Chief Revenue Officer as demand grows for flexible, high-performance manufacturing environments across pharma and biotech.
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Navigating Change: Key Industry Insights At PHARMAP 20264/27/2026
The Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) 2026 brought together senior industry leaders on 20-21 April in Amsterdam for two days of focused discussion on the forces reshaping pharmaceutical manufacturing. Held in partnership with Astellas Pharma Europe, GSK, ESTEVE, Laboratoires Théa and Recipharm, the Congress covered global manufacturing strategies, supply chain resilience, packaging innovation and many other topics.
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AbbVie Announces $1.4 Billion North Carolina Campus To Expand U.S. Pharmaceutical Manufacturing Capacity4/27/2026
AbbVie today announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie's immunology, neuroscience and oncology medicines.
