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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![cdmo-solid-dose-GettyImages-1432665138]( "Safely Scaling High Potency API Manufacturing")
Safely Scaling High Potency API ManufacturingScaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.
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Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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Vial Fogging: Practical Considerations For Vial Selection10/16/2024
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
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Molecular Properties Of PROTACs And The Relationship To Formulation Design3/4/2025
Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.
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Connecting Quality Management, Patient-Centricity, And Business Value2/18/2025
Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Site Transfer Of Tablet Production From Ex-U.S. To Georgia Site
- Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing
- Re-Engineering A Complex Process For FDA Compliance
- Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods
- Time-To-Manufacture Reduced By 30% Through Rapid Transfer Strategy
NEWSLETTER ARCHIVE
- 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
- 04.28.26 -- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
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.
