FEATURE ARTICLES
When using artificial intelligence in GMP settings, risk management extends far beyond validation. This discussion explores moving AI solutions out of the pilot phase.
- Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
- The Complex Anatomy Of An ADC Tech Transfer
- A Much-Improved Approach For Understanding And Managing Safety Risks
- CSV Assumes The AI System Sits Still — It Doesn't.
- AI Needs Human Oversight To Better GMP Documentation
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- 6 Reasons Pharma Manufacturing Has Eyes On Puerto Rico
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
A Risk-Based Approach To Plasmid DNA And mRNA Process DevelopmentBalancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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Email Etiquette That Actually Saves Time for Pharma & Biotech5/12/2026
Smarter email habits cut wasted time, reduce inbox noise, and improve collaboration. Clear subject lines, careful recipients, and purposeful tool use keep teams focused on meaningful work.
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Selecting The Best Deterministic Method For Your CCIT Project3/31/2025
Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.
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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Outdated quality systems delay product release.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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History Of Peptides In Medicine: From Early Chemistry To The GLP-1 Era4/21/2026
Peptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug development.
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An Overview Of 2026 Life Sciences Industry Trends6/3/2026
Explore the paradigm shift reshaping life sciences. Learn how connecting data streams across the product lifecycle drives predictive compliance and operational excellence.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 08.28.26 -- Capabilities For Choosing The Right CDMO For Cell Line Development Success
- 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery
- 08.27.26 -- CSV Assumes The AI System Sits Still — It Doesn't.
- 08.27.26 -- Changing Inspection Readiness Into Continuous Improvement
- 08.26.26 -- De-Risking Combination Product Development For Complex Biologics
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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JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program8/28/2026
Jubilant HollisterStier(JHS) and Altoura will be of only three company-CDMO pairs participating in the BioTools Innovator VANGUARD Level Up-XR Program.
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Syntegon Launches New Pilot Scale Tablet Coater For Small Batches8/26/2026
Syntegon, a strategic lifecycle partner to the pharmaceutical and biotech industry has expanded its Oral Solid Dosage (OSD) processing portfolio with the Sepion 75. The new pilot-scale tablet coater designed to support manufacturers and CDMOs in handling growing product diversity, smaller and more variable batch sizes, and stricter containment requirements for highly potent active ingredients. The new coater completes the established Sepion series and supports consistent scale-up, faster flexible batch processing, and containment-oriented manufacturing.
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Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities8/25/2026
Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced the successful completion of three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA). The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network.
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CleanSpace Names Pharma Industry Veteran Will Knapp Midwest Sales Director8/25/2026
Will Knapp joins CleanSpace as Director of Sales for the Midwest, bringing morethan 25 years of pharma facility design, construction, and validation expertise.
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METTLER TOLEDO Introduces LightningBuild Program For Four-Week Delivery8/13/2026
METTLER TOLEDO Product Inspection Group introduces its LightningBuild program, which delivers select product inspection systems from purchase order to the customer’s dock within four weeks. The program is launching with the X12 LightningBuild x-ray inspection system and the C31 LightningBuild checkweigher, both on exhibit for the first time at Pack Expo in booth 2122. Available at no additional charge, LightningBuild is designed for food and pharmaceutical manufacturers that need to start, expand or adapt operations quickly.
