FEATURE ARTICLES
Case studies reveal the gap between research progress and clinical readiness. In these stories, earlier CMC involvement might have saved resources and staved off delays.
- IT/OT Convergence Could Lighten Biopharma's Automation Burden
- How Peptides Are Expanding The Possibilities Of Drug Discovery
- The 2026 Pharma R&D AI Sourcing Map: Partnerships, Concentration, Inflection
- Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review
- What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI
- How To Keep Your 'Big Bang' Platform Switch From Becoming A Big Bust
- FDA Rethinks Skin Sensitization Testing For Generic Transdermal And Topical Delivery Systems
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1783586499 regulatory compliance]( "GMP Calibration Management")
GMP Calibration ManagementLearn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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Enabling Quality By Design9/8/2025
Outdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.
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Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies5/5/2025
Meeting 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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Pharmaceutical Spray Drying – Technology And Applications1/21/2025
Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.
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Finding An Optimal Harvest Solution By Considering Both Cost And Sustainability3/27/2025
Optimize your bioprocessing harvest with single-use centrifugation. Reduce costs, waste, and space needs compared to traditional depth filtration methods.
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FM Approval Standard 48829/21/2026
A fire in a pharmaceutical cleanroom can be contained, but for sterile manufacturers, smoke can turn a localized event into a far wider decontamination, requalification, and production-recovery challenge.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
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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.
EDITORIAL COLLECTIONS
Our curated Editorial Collections bring expert insights together in one place, offering practical perspectives and actionable guidance to help you navigate complex decisions and improve performance.
More Editorial CollectionsSUPPLIER NEWS
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Lonza Signs Agreement To Acquire US CDMO Network From Merck KGaA, Darmstadt, Germany, And Significantly Expands Its US Presence11/3/2026
Lonza, the world’s leading contract development and manufacturing organization (CDMO), announced today that it has signed a definitive agreement to acquire five CDMO manufacturing sites in the US from Merck KGaA, Darmstadt, Germany at a total enterprise valuation in the low- to mid-triple-digit millions Swiss francs.
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Bracco To Build New Injectable Drug Manufacturing Facility In North Carolina11/2/2026
Bracco, a global leader in diagnostic imaging, today announced plans to invest $230 million to establish its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. Expected to create 200 jobs, the investment marks a significant milestone in Bracco's global manufacturing strategy, expanding production capacity and strengthening supply chain resilience in the United States, the company's largest market.
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Lonza Further Expands Bioconjugation Manufacturing To Support Growing ADC Demand10/29/2026
Lonza, the world’s leading contract development and manufacturing organization (CDMO), announced today the further expansion of its integrated bioconjugation manufacturing offering. Lonza is combining the flexibility of mid-scale bioconjugation manufacturing with its previously announced large-scale bioconjugation expansion in Visp (CH), which will now include three multiproduct suites. Together, these capabilities will offer customers a scalable manufacturing pathway from clinical development through commercial supply for antibody-drug conjugates (ADCs) and other bioconjugates.
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ROSS Portable High Shear Mixing System10/29/2026
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Ardena Launches Online Biomarker Catalogue: 228 Markers, One Quote Request10/29/2026
Ardena has launched a searchable Biomarker Catalogue on its website, giving sponsors a faster route from biomarker selection to a bioanalysis quote.
