FEATURE ARTICLES
The FDA has released a new draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. The document is set to replace the 2023 version.
- Modulus Brings Home Top Award At 2026 FOYAs
- Designing Pharma Facilities For Change, Not Just Capacity
- September 2026 — CDMO Opportunities And Threats Report
- An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
- Why Early Evaluation Of Process Parameters Matters In OSD Scale-Up
- Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
- Is Your Supply Chain Ready For The End Of Class VI?
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2215842261-lab-scientist-looking-down-research]( "A Guide To Process Transparency In Custom Lab Automation Development")
A Guide To Process Transparency In Custom Lab Automation DevelopmentDiscover a practical guide to building custom automation systems with clarity and confidence, as well as how transparent processes reduce risk, prevent misalignment, and support reliable testing.
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Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends3/12/2025
Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.
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How To Prepare For Risk-based Biological Reactivity Testing10/16/2026
Biological reactivity testing is moving from material classification toward risk-based evaluation, where chemistry data, exposure, and application determine what evidence is enough for each material.
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Quality: The Link Between Platform, Processes, And Patients2/18/2025
Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
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Optimizing mAb Production: Upstream Process Intensification Strategies9/1/2026
See how integrated upstream and downstream intensification strategies can increase monoclonal antibody yield, streamline workflows, improve facility utilization, and reduce manufacturing costs.
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Criteria For Effective Bioprocess Scale-Up3/25/2026
Discover four essential bioprocess scale-up criteria and how each balances hydrodynamics, shear, and mass transfer across manufacturing scales.
PHARMA ONLINE APP NOTES & CASE STUDIES
- The Benefits Of Aqueous Critical Cleaning
- Improving Stability Through Science-Led OSD Reformulation
- Verve Puts Digital-First Quality At The Heart Of Its QC Lab
- Managing Risk In The Most Complex Combination Device Format
- Characterization Of Fly-Derived Prolactin: Insights Into Glycosylation And Activity
NEWSLETTER ARCHIVE
- 11.03.26 -- Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
- 11.03.26 -- Where Speed Is Lost: Fixing Handoffs In BioPharma Operations
- 11.02.26 -- What's Next in Pharmaceutical Packaging?
- 11.02.26 -- Is Your Pharma Factory Ready For What's Next?
- 10.31.26 -- Aseptic Contract Manufacturing Services
- Modulus Brings Home Top Award At 2026 FOYAs
- Designing Pharma Facilities For Change, Not Just Capacity
- Why Early Evaluation Of Process Parameters Matters In OSD Scale-Up
- Printing A New Path To The Brain: 3D Buccal Nanofilms For CNS Lymphoma
- Capturing Tablet Disintegration for Improved OSD Development
NEW FOR OUR READERS
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.
