FEATURE ARTICLES
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- Why CMC Tech Transfer Should Begin With The End In Mind
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2152031133-atom-hand-gear-wrench-automation]( "The AI-Ready Factory: How IT/OT Integration Transforms Manufacturing Data")
The AI-Ready Factory: How IT/OT Integration Transforms Manufacturing DataPharmaceutical manufacturers need more than raw production data to scale AI. Learn how contextualized, governed IT/OT integration can turn disconnected shop-floor signals into real-time decisions.
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Color Consistency In UHMWPE Medical Textiles3/26/2026
Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.
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The Connectivity Crisis Blocking AI Deployment6/30/2026
Disconnected systems and siloed data block analytics in life sciences manufacturing. Learn to bridge the infrastructure gap and build a connected foundation for scalable intelligence.
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Sustainability In Small Molecule API Manufacturing11/7/2025
Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.
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Advancing ADCs With Expertise In Payloads And Linkers2/18/2026
Discover how integrated containment, high-potency expertise, advanced chromatography, and proven linker–payload process optimization can accelerate your ADC program from early development to reliable commercial supply.
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Selecting A CDMO For Custom Activated PEGs1/27/2026
Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 10.06.26 -- The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem
- 10.06.26 -- Continuous Environmental Monitoring
- 10.03.26 -- Aseptic Manufacturing Product Showcase
- 10.02.26 -- Navigating The Future Of Large-Volume Biologic Delivery
- 10.02.26 -- 4 Ways To Building A Better CMC Tech Transfer
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.
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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.
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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Upperton Unveils New Brand Identity Reflecting Evolution Into Specialist CDMO10/6/2026
Upperton has unveiled a new brand identity at CPHI Milan, marking a significant milestone in the company's evolution into a specialist, end-to-end contract development and manufacturing organisation (CDMO) focused on solving the challenges of molecule development across oral, nasal, pulmonary and parenteral dosage forms.
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Hovione To Commission World's First ConsiGma® CDC Flex, Bringing Next-Generation Continuous Tableting To The U.S.10/5/2026
Hovione, a globally integrated pharmaceutical contract development and manufacturing organization (CDMO), today announced it will commission the world’s first ConsiGma® CDC Flex – a next generation continuous tableting line – at its East Windsor, New Jersey campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione's recently opened facility, expanding the company´s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the U.S.
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Agilent Expands Oligonucleotide Manufacturing Capabilities With New Boulder Lab10/5/2026
Agilent Technologies Inc. (NYSE: A) today announced the addition of new laboratory space in Boulder, Colorado, to support the expansion of its oligonucleotide manufacturing capabilities. The facility is expected to support the development and scale-up of emerging manufacturing technologies for oligonucleotide therapeutics, initially focusing on enzymatic ligation.
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Bayer Expanding U.S. Pharmaceutical Manufacturing Footprint With New Ohio Manufacturing Facility10/5/2026
Company plans to build state-of-the-art site in New Albany, Ohio, U.S., to serve patients in the U.S. as well as globally / Bayer expects to create around 600 new high-value jobs in the area / Multi-year investment reinforces U.S. business expansion and adds to more than seven billion dollars in U.S. pharma R&D and manufacturing expenditure over past five years.
