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The FDA has released a new draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.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
-
![GettyImages-2179548801-ADC-3d-render]( "Advancing ADCs: From Concept To Commercialization")
Advancing ADCs: From Concept To CommercializationADC programs move fastest when payload-linker strategy, route design, conjugation, and drug product are planned together, with timelines and scale-up capacity shaping choices from the earliest development stages.
-
Coordinated Development As An Execution Framework6/9/2026
See how integrating clinical, development, manufacturing, and supply functions within a single execution framework can transform program performance and accelerate development success.
-
Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling9/9/2026
At roughly 600,000 samples per year, manual EM documentation creates real compliance and operational risk. This whitepaper details how a fully integrated digital sampling system addresses both.
-
Transformative Innovation: Advancing Drug Development Using In Silico Modeling3/4/2026
Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.
-
The Importance Of Quality In Raw Material Selection1/16/2025
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
-
Navigating Digital Transformation For Pharmaceutical CDMOs10/31/2025
Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.
PHARMA ONLINE APP NOTES & CASE STUDIES
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
-
![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.
-
![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.
-
![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
-
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.
-
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.
-
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.
-
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.
-
Meissner Hosts Ribbon Cutting Ceremony For X-Ray Irradiation Services And Breaks Ground On Phase 2 Of Its Athens, Georgia, U.S.A. Campus10/23/2026
Meissner Corporation, a leading manufacturer of advanced microfiltration and therapeutic manufacturing systems for biopharmaceutical production of life-saving and life enhancing medicines, celebrated a double milestone in Athens-Clarke County: the ribbon cutting for its new X-ray irradiation services facility and the groundbreaking for Phase 2 of its Athens, Georgia, U.S.A., manufacturing campus.
